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Mysterious Vaping Lung Injuries May Have Flown Under Regulatory Radar

LOS ANGELES SENTINEL — It was the arrival of the second man in his early 20s gasping for air that alarmed Dr. Dixie Harris. Young patients rarely get so sick, so fast, with a severe lung illness, and this was her second case in a matter of days. Then she saw three more patients at her Utah telehealth clinic with similar symptoms. They did not have infections, but all had been vaping. When Harris heard several teenagers in Wisconsin had been hospitalized in similar cases, she quickly alerted her state health department.

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Vaping (Photo by: Grant Williams | pexels.com)

By Sydney Lupkin and Anna Maria Barry-Jester

It was the arrival of the second man in his early 20s gasping for air that alarmed Dr. Dixie Harris. Young patients rarely get so sick, so fast, with a severe lung illness, and this was her second case in a matter of days.

Then she saw three more patients at her Utah telehealth clinic with similar symptoms. They did not have infections, but all had been vaping. When Harris heard several teenagers in Wisconsin had been hospitalized in similar cases, she quickly alerted her state health department.

As patients in hospitals across the country combat a mysterious illness linked to e-cigarettes, federal and state investigators are frantically trying to trace the outbreaks to specific vaping products that, until recently, were virtually unregulated.

As of Aug. 22, 193 potential vaping-related illnesses in 22 states had been reported to the Centers for Disease Control and Prevention. California is investigating 22 cases. Wisconsin, which first put out an alert in July, has at least 16 confirmed and 15 suspected cases. Illinois has reported 34 patients, one of whom has died. Indiana is investigating 24.

Lung doctors said they had seen warning signs for years that vaping could be hazardous, as they treated patients. Medically it seemed problematic, since it often involved inhaling chemicals not normally inhaled into the lungs. Despite that, assessing the safety of a new product storming the market fell between regulatory cracks, leaving doctors unsure where to register concerns before the outbreak. The Food and Drug Administration took years to regulate e-cigarettes once a court determined it had the authority to do so.

“You don’t know what you’re putting into your lungs when you vape,” said Harris, a critical care pulmonologist at Intermountain Healthcare in Salt Lake City. “It’s purported to be safe, but how do you know if it’s safe? To me, it’s a very dangerous thing.”

Dr. Laura Crotty Alexander, a pulmonologist and researcher with the University of California-San Diego, said she saw her first case about two years ago. A young man had been vaping for months with the same device but developed acute lung injury when he switched flavors. She strongly suspected a link but did not report the illness anywhere.

“It wasn’t that I didn’t want to report it, it’s that there’s no pathway” to do so, Alexander said.

She said she’s concerned that many physicians haven’t been asking patients about e-cigarette use and that there’s no way to document a case like this in the medical coding system.

Off The Radar

When electronic cigarettes came to market about a decade ago, they fell into a regulatory no man’s land. They are not a food, not a drug and not a medical device, any of which would have put them immediately in the FDA’s purview. And, until a few years ago, they weren’t even lumped in with tobacco products.

As a result, billions of dollars of vaping products have been sold online, at big-box retailers and in corner stores without going through the FDA’s rigorous review process to assess their safety. Companies like Blu, NJoy and Juul, which is based in San Francisco, quickly established their brands of devices and cartridges, or pods. And thousands of related products are sold, sometimes on the black market over the internet or beyond.

“It makes it really tough because we don’t know what we’re looking for,” said Dr. Ruth Lynfield, the state epidemiologist for Minnesota, where several patients were admitted to the intensive care unit as a result of the illness. She added that if it turns out that the products in question were sold by unregistered retailers and manufacturers “on the street,” outbreak sleuths will have a harder time figuring out exactly what is in them.

With e-cigarettes, people can vape — or smoke — nicotine products, selecting flavorings like mint, mango, blueberry crème brûlée or cookies and milk. They can also inhale cannabis products. Many are hopeful that e-cigarettes might be useful smoking cessation tools, but some research has called that into question.

The mysterious pulmonary disease cases have been linked to vaping, but it’s unclear whether there is a common device or chemical. In some states, including California and Utah, all of the patients had vaped cannabis products. One or more substances could be involved, health officials have said. The products used by several victims are being tested to see what they contained.

Because e-cigarettes aren’t classified as drugs or medical devices, which have well-established FDA databases to track adverse events, doctors say there has been no clear way to report and track health problems related to vaping products.

And this has apparently been the case for years.

Multiple doctors described seeing earlier cases of severe lung problems linked to vaping that were not officially reported or included in the current CDC count.

Dr. John E. Parker of West Virginia University said he saw his first patient with pneumonia tied to vaping in 2015. Doctors there were intrigued enough to report on the case at the annual meeting of the American College of Chest Physicians. Parker and his team didn’t contact a federal agency, and Parker said it was unclear whom to call.

Numerous other cases have been reported in medical journals and at professional conferences in the years since. The FDA’s voluntary system for reporting tobacco-related health problems included 96 seizures and only one lung ailment tied to e-cigarettes from April through June of this year. The system appears to be utilized most by concerned citizens, rather than manufacturers or health care professionals.

But several lung specialists said that due to the patchwork nature of regulatory oversight over the years, the true scope of the problem is yet to be identified.

“We do know that e-cigarettes do not emit a harmless aerosol,” said Brian King, a deputy director in the Office on Smoking and Health at the CDC in a call with media on Aug. 23 about the outbreak. “It is possible that some of these cases were already occurring but we were not picking them up.”

Regulatory Limits

The FDA has had limited authority to regulate e-cigarettes over the years.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, empowering the FDA to oversee the safety and sale of tobacco products. But e-cigarettes, still new, were not top of mind.

Later that year, the FDA tried to block imports of e-cigarettes, saying the combination drug-device products were unapproved and therefore illegal for sale in the United States. Two vaping companies, Smoking Everywhere and NJoy, sued, and a federal judge ruled in 2010 that the FDA should regulate e-cigarettes as tobacco products.

It took the agency six years to finalize what’s become known as the “deeming rule,” in which it formally began regulating e-cigarettes and e-liquids.

By then, it was May 2016. The e-cigarette market had swelled to an estimated $4.1 billion, Wells Fargo Securities analyst Bonnie Herzog said at the time. Market researchers now project that the global industry could reach $48 billion by 2023.

Critics say the FDA took too long to act.

“I think the fact that FDA has been dillydallying [has made] figuring out what’s going on [with this outbreak] much harder,” said Stanton Glantz, a University of California-San Francisco professor in its Center for Tobacco Control Research and Education. “No question.”

The agency began by banning e-cigarette sales to minors and requiring all new vaping products to submit applications for authorization before they could come to market. Companies and retailers with thousands of products already on the market were granted two years to submit applications, and the FDA would get an additional year to evaluate the applications. Meanwhile, existing products could still be sold.

But when Dr. Scott Gottlieb arrived as the new FDA commissioner in 2017, the rule hadn’t been implemented and there was no formal guidance for companies to file applications, he said. As a result, he pushed the deadline back to 2022, drawing ire from public health advocates, who called foul over his previous ties to an e-cigarette retailer called Kure.

“I thought e-cigarettes at the time — and I still believe — that they represent an opportunity for currently addicted adult smokers to transition off of combustible tobacco,” he said in an interview, adding that other parts of the deeming rule went into effect as planned. “All I did was delay the application deadline.”

Gottlieb’s thinking changed the following year, when a national survey showed a sharp rise in teen vaping, which he called an “epidemic.” He announced that the agency would rethink the extended deadline and weigh whether to take flavors that appeal to kids off the market.

A judge ruled last month that e-cigarette makers would have only 10 more months to submit applications to the FDA. They’re now due in May 2020.

Asked about the lung injuries appearing now, Gottlieb, who left the FDA in April, said he suspected counterfeit pods are to blame, given the geographic clustering of cases and the fact that, overall, the FDA is inspecting registered e-cigarette makers and retailers to make sure they’re complying with existing regulations.

“I think the manufacturers are culpable if their products are being used, whether the liquids are counterfeit or real,” he said. “Ultimately, they’re responsible for keeping their products out of the hands of kids.”

Juul, the leading e-cigarette maker, agreed that children shouldn’t be able to vape its products, and said curtailing access should be done “through significant regulation” and “enforcement.”

“When people say ‘Why aren’t these being regulated?’ They actually are all being regulated,” Gottlieb said.

For example, companies are required to label their products as potentially addictive, sell only to adults and comply with manufacturing standards. The agency has conducted thousands of inspections of e-cigarette manufacturers and retailers and taken enforcement actions against companies selling e-cigarettes that look like juice boxes, and a company that was putting the ingredients found in erectile dysfunction drugs into its vape liquid.

Health departments investigating the outbreak told Kaiser Health News that e-cigarettes’ niche as a tobacco product instead of a drug has presented challenges. Most weren’t aware that adverse events could be reported to a database that tracks problems with tobacco products. And, because e-cigarettes never went through the FDA’s “gold standard” approval process for drugs, doctors can’t readily look up a detailed list of known side effects.

But like other arms of the FDA, the tobacco office has tools and a team to investigate a public health threat just as the teams for drugs and devices do, Gottlieb said. It may even be better equipped because of its funding.

“I don’t think FDA is operating in any way with hands tied behind its back because of the way that the statute is set up,” he said.

Teen vaping has exploded during this regulatory tussle. In 2011, 1.5% of high school students reported vaping. By 2018, it was 20.8%, according to a CDC report.

Unknown Components

Still, doctors and researchers are concerned about the ingredients in e-cigarettes, and how little the public knows about the risks of vaping.

In Juul’s terms and conditions, posted on its website, it says, “We encourage consumers to do their own research regarding vapor products and what is right for them.” Many ingredients in e-cigarette products, however, are protected as trade secrets.

Since at least 2013, the flavor industry has expressed concern about the use of flavoring chemicals in vaping products.

The vast majority of the chemicals have been tested only by ingesting them in small quantities, as they’re encountered in foods. For most of these chemicals, there have been no tests to determine whether it is safe to inhale them, as happens daily by millions when they use e-cigarettes.

“Many of the ingredients of vaping products, including flavoring substances, have not been tested for … the exposure one would get from using a vaping device,” said John Hallagan, a senior adviser to the Flavor and Extract Manufacturers Association. The group has sent cease-and-desist letters to e-cigarette companies in previous years for using the food safety certification of the flavor industry to imply that the chemicals are also safe in e-cigarettes.

Some flavor chemicals are thought to be harmful when inhaled in high doses. Research suggests that cinnamaldehyde, the main component of many cinnamon flavors, may impair lung function when inhaled. Sven-Eric Jordt, a professor at Kaiser Health News, says he presented evidence of its dangers at an FDA meeting in 2015 — and its relative abundance in many e-cigarette vaping liquids. In response, one major e-cigarette liquid seller, Tasty Vapor, voluntarily took its cinnamon-flavored liquid off the shelves.

In 2017, when Gottlieb delayed the FDA application deadline, the product was back. A company email to its customers put it this way:

“Two years ago, Tasty Vapor allowed itself to be intimidated by scaremongering tactics. … We lost a lot of sales as well as a good number of long time customers. We no long see reason to disappoint our customers hostage for these shady tactics.”

At the time of publication, Tasty Vapor’s owner did not reply to a request for comment.

Jordt said he is frustrated by the delays in the regulatory approval process.

“As a parent, I would say that the government has not acted on this,” he said. “You’re basically left to act alone with your addicted kid. It’s kind of terrifying that this was allowed to happen. The industry needs to be held to account.”

Kaiser Health News correspondents Cara Anthony, Markian Hawryluk and Lauren Weber and reporter Victoria Knight contributed to this report. 

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

This article originally appeared in The Los Angeles Sentinel.

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FILM: Top 10 Must-See Black documentaries

NNPA NEWSWIRE — Below you will find a list of documentaries, based on the roots of African American culture, compiled by Word in Black partner, The Houston Defender. From “I Am Not Your Negro” to “High on the Hog,” each film offers up the origin stories of our most important activists, artists, athletes and traditions.
The post FILM: Top 10 Must-See Black documentaries first appeared on BlackPressUSA.

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By The Houston Defender | Word in Black

The AFRO’s October Special Edition is all about the roots of our culture, our family lineage and the return to old ways and traditions. Below you will find a list of documentaries, based on the roots of African American culture, compiled by our Word in Black partner, The Houston Defender. From I Am Not Your Negro to High on the Hog, each film offers up the origin stories of our most important activists, artists, athletes and traditions.

#10: Attica (2021) 

In September 1971, Attica Prison became the location of one of the largest prison riots in US history, taking place just weeks after revolutionary activist George Jackson was murdered by prison guards at Rikers Island, an act that initiated the birth of Black August and the prison reform movement. The constant abject cruelty and inhumane treatment doled out to the incarcerated (who were overwhelmingly Black and Latinx) by Attica guards (all White) created the context. The riot itself, and its aftermath, are something all human beings should be required to reckon with.

#9: Quincy (2018) 

If you’re Black, it literally doesn’t matter when you were born, what generation you’re a part of, or where you’re from. You’ve been impacted by the genius of Quincy Jones. We’ve all been influenced by the genius of Quincy Jones. The music he made, the albums he produced, the artists he developed, the movies he scored, and about a gazillion other things Jones did, means, as I’ve already said, if you’re Black, Quincy has had a hand in your life. Don’t believe me. What Black person do you know who isn’t a Michael Jackson fan, who hasn’t seen The Wiz, or who doesn’t have a family member who worships jazz music? Quincy Jones had his hand in all that and so much more. Directed by one of his daughters, actress Rashida Jones, this doc is most definitely a must see.

#8: Four Little Girls (1997) 

On Sept. 15, 1963, just 18 short days after the much-celebrated March on Washington for Jobs and Freedom, the 16th Street Baptist Church in Birmingham, Ala., was bombed by four members of a Ku Klux Klan-affiliated racist group. Addie Mae Collins, Denise McNair, Carole Robertson, and Cynthia Wesley, four African American girls between the ages of 11 and 14 who had been attending the church’s Sunday school, were killed in the blast, an act of White domestic terrorism that served as a horrific and sober reminder that Dr. King’s “I Have a Dream” speech was not enough to end the hold the myth of White supremacy had on so many. Director Spike Lee tells this powerfully compelling and important story as only he can.

#7: The Two Killings of Sam Cooke (2019) 

For generations that came after the Baby Boomers, it’s hard for us to fully fathom how big a star Sam Cooke was. Think of the biggest singer of any generation. That was Sam Cooke in his heyday. And not only was he hyper-talented, but not only did he call some of the biggest names in Black history his personal friends (Muhammad Ali and Malcolm X just to name a few), Cooke was a man of the people. And he was heavily invested in the Civil Rights Movement and an advocate for Black self-determination and Black ownership. Cooke even pulled a “Prince” long before Prince—gaining ownership of his own music, something that was as rare then as it is today. This documentary chronicles Cooke’s life, rise to fame, and eventual end, though his influence never died.

#6: Thunder Soul (2010) 

Here’s a hometown entry. Thunder Soul spotlights the extraordinary alumni from Houston’s storied Kashmere High School Stage Band which the iconic Conrad Johnson led. These alums return home after 35 years to play a tribute concert for the 92-year-old ‘Prof’, their beloved band leader who transformed the schools struggling jazz band into a world-class funk powerhouse in the early 1970s. This one will have you out of your seat and dancing in the streets. Check it out.

#5: Who We Are: A Chronicle of Racism in America (2021)  

In this documentary, criminal defense/civil rights lawyer Jeffery Robinson “draws a stark timeline of anti-Black racism in the United States, from slavery to the modern myth of a post-racial America.” It’s that simple, and yet that complex. And it goes without saying; it’s a must see.

#4: Jeen-Yuhs (2022) 

No matter where you score on the Love Ye / Hate Ye scale, this 2022 documentary about his rise to superstardom is beyond compelling. I mean, who thinks to chronicle their every move from the moment they start pursuing their dream until they either give up on it or see it to fruition and beyond? Who does that? No one but this negro Kanye. He may be the only human being with an ego big enough to conceive of such a project. And believe me, the scope and scale of this documentary match that galaxy-sized self-obsession brahman has that make him both insanely talented and just plain insane at the same time.

#3: I Am Not Your Negro (2016) 

This documentary by Raoul Peck, director of Exterminate All the Brutes (2021) which made the first list of must-see documentaries, introduced the brilliance and unabashed Black of James Baldwin to a whole new generation. Described as a work that imagines the completion of Baldwin’s unfinished manuscript, Remember This House (about Baldwin’s personal reflections on and recollections of three of his personal friends who were killed during the Civil Rights and Black Power movements—Medgar Evers, Malcolm X, and Rev. Dr. Martin Luther King Jr.), I Am Not Your Negro is about so much more.

#2: The Last Dance (2020) 

You don’t have to be a basketball fan to get caught up in the chronicling of the last run at an NBA championship by the Michael Jordan-led Chicago Bulls who had been told before the season began that the team would be broken up. The doc not only takes you on that 1996 Bulls’ championship ride, but it also digs deep into the past of players, coaches, and family members, spotlighting triumphs and tragedies that are part of the human story, not just the story of professional athletes.

#1: High on the Hog 

How African American Cuisine Transformed America (2021)

If you know me, you know I’m a sucker for anything that celebrates our history, especially those things that connect us to our African roots and our Pan-African family. This documentary does all that and more. Because the main character is food. Our food. The stuff we grew up on. The meals many of us are eating right now, and never stopped eating since our youth. This beautifully filmed, beautifully narrated piece of art is full of both the familiar and the foreign; or rather, things we’ve come to believe are foreign to us, but are really part of our story and our heritage. And the okra on top? High on the Hog has a powerful H-Town connection. A few, in fact.

This list of documentaries based on the roots of African American culture was compiled by Word In Black.

This article originally appeared in The Afro.

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Lawsuit Alleges U.S. Government Discriminated Against Black Veterans for Decades

NNPA NEWSWIRE — According to internal VA data obtained by the Washington Post, Black applicants seeking disability benefits were denied 30 percent of the time from 2002 to 2020. White applicants were denied 24 percent of the time.
The post Lawsuit Alleges U.S. Government Discriminated Against Black Veterans for Decades first appeared on BlackPressUSA.

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Black Information Network | Atlanta Daily World

A new lawsuit against the Department of Veterans Affairs (VA) alleges that the U.S. government discriminated against Black veterans for decades.

On Monday (November 28), the suit was filed by Yale Law School’s Veterans Legal Services Clinic (VLSC) on behalf of Vietnam War veteran Conley Monk Jr, whose applications for education, housing, and disability benefits have been denied since he returned home from the war, per The Hill.

According to the suit, discrimination by the VA has left Black veterans without benefits more frequently than their white counterparts.

Yale’s VLSC said the lawsuit could “provide a legal pathway for Black veterans to seek reparations from the VA.”

“This lawsuit seeks to hold the VA accountable for years of discriminatory conduct,” Adam Henderson, a law student working with the VLSC on the case, said in a statement, per the Hill.

“VA leaders knew, or should have known, that they were administering benefits in a discriminatory manner, yet they failed to address this unlawful bias,” Henderson added. “Mr. Monk — and thousands of Black veterans like him — deserve redress for the harms caused by these negligently administered programs.”

According to internal VA data obtained by the Washington Post, Black applicants seeking disability benefits were denied 30 percent of the time from 2002 to 2020. White applicants were denied 24 percent of the time.

VA press secretary Terrence Hayes said the agency is working to combat “institutional racism.”

“Throughout history, there have been unacceptable disparities in both VA benefits decisions and military discharge status due to racism, which have wrongly left Black veterans without access to VA care and benefits,” Hayes said. “We are actively working to right these wrongs.”

The post U.S. Government Discriminated Against Black Veterans For Decades: Lawsuit appeared first on Atlanta Daily World.

The post Lawsuit Alleges U.S. Government Discriminated Against Black Veterans for Decades first appeared on BlackPressUSA.

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BOOKS: Jerald LeVon Hoover Blends a Love of Sport & Friendship into New Children’s Book

NNPA NEWSWIRE — Through colorful pictures with vibrant imagery, young readers will easily get drawn into the exciting adventures of Bennett Mayco Wilson’s fictional yet exciting world and learn valuable childhood lessons together, when Bennet gets a basketball as a present from his father on his fourth birthday.
The post BOOKS: Jerald LeVon Hoover Blends a Love of Sport & Friendship into New Children’s Book first appeared on BlackPressUSA.

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‘A Basketball Hero is Born’ is a part of The Hero Book Series by Jerald LeVon Hoover, which aims to inspire youth to make a positive change in their communities and the world in general

Widely celebrated African American author, Jerald LeVon Hoover, is once again inspiring young people to make a positive change in their communities with the launch of a new children’s book. Titled A Basketball Hero is Born, the new children’s reading book contains colorful pictures that warm the heart and keep young readers glued to its pages.

The plot follows the exciting adventures of Bennett Mayco Wilson who gets a basketball as a present from his father on his fourth birthday. Affectionately naming the new basketball “Lucky,” the story unfolds as young Bennett tries to take his new best friend everywhere, including the dinner table, to school, and to bed when it is time for sleep.

Jerald L. Hoover

Jerald L. Hoover

Through colorful pictures with vibrant imagery, young readers will easily get drawn into Bennett’s fictional yet exciting world and learn valuable childhood lessons together. Currently available for purchase on Amazon, A Basketball Hero is Born is a part of The Hero Book Series by Jerald LeVon Hoover, which emphasizes instilling a love of sports and friendship in young readers.

About The Author

Jerald L. Hoover is a multi-talented individual with countless accomplishments in the creative, literary, and entertainment worlds. After winning an award for “The Best New Male Writer of the Year” for his fictional novel, My Friend, My Hero Jerald went on to be listed from 1994 – 1996 as a best-selling author among young Black writers in various African American publications. In 1995, he was awarded the Writers Corp Award by then-President Bill Clinton. In 1998, Jerald was inducted into the Mount Vernon Boy’s and Girl’s Club Hall of Fame. Since then, Jerald has won several other awards and is also an in-demand motivational speaker who overcame a childhood speech impediment.

The post BOOKS: Jerald LeVon Hoover Blends a Love of Sport & Friendship into New Children’s Book first appeared on BlackPressUSA.

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