A 17-year-old boy whose lungs were irreversibly damaged by vaping received a double-lung transplant at the Henry Ford Hospital in Detroit, a lifesaving measure taken when a patient’s own lungs are diseased or damaged beyond repair and there is no other hope of survival, doctors said Tuesday.
Without the transplant, performed last month, the patient “would have faced certain death,” Dr. Hassan Nemeh, who led the surgical team, said during a news conference at the hospital.
The patient’s lungs were scarred, stiffened, pocked with dead spots and extremely inflamed, he said. On a CT scan before the surgery, the patient’s chest appeared almost empty, as if the lungs had vanished. Normal lungs look dark on imaging because they are full of air; the patient’s were not visible because they were not working. There was no air.
“What I saw in his lungs is like nothing I’ve seen before, and I’ve been doing lung transplants for 20 years,” Nemeh said. He added, “This is an evil I haven’t faced before.”
The patient is recovering well and is up and about now, but still in the hospital. His name is being withheld to protect his privacy, but he and his family wanted to release information about his case in the hope that it might persuade other people to quit vaping or never start, hospital officials said.
A doctor at the briefing read a statement from the family, which said, in part:
“We asked Henry Ford doctors to share that the horrific life-threatening effects of vaping are very real! Our family could never have imagined being at the center of the largest adolescent public health crisis to face our country in decades.
“Within a very short period of time, our lives have been forever changed. He has gone from the typical life of a perfectly healthy 16-year-old athlete — attending high school, hanging out with friends, sailing and playing video games — to waking up intubated and with two new lungs, facing a long and painful recovery process as he struggles to regain his strength and mobility, which has been severely impacted.”
The doctors declined to say what products the patient had been vaping, how long he had been doing it or how often. About 86% of the patients with lung injuries in this outbreak had vaped THC, the chemical in marijuana that makes people high.
The case is the first transplant reported in the nationwide outbreak of vaping-related lung injuries, and it highlights the severity of an illness that, as of Nov. 5, had sickened 2,051 people and killed 40. Researchers have described the lung damage from vaping as chemical burns, similar to the injuries in people who have inhaled toxic fumes in industrial accidents, or in soldiers attacked with mustard gas in World War I.
The patient was first admitted to a different hospital on Sept. 6 with what was thought to be pneumonia. His condition worsened and he was placed on a ventilator on Sept. 12. He continued to deteriorate. On Sept. 17, he was transferred to a second hospital, where he was connected to a machine that delivers oxygen directly to the bloodstream.
His health continued to decline, and in early October, he was transferred to Henry Ford Hospital, where he was put on the waiting list for a lung transplant. A national organization sets the criteria for eligibility, not individual hospitals. Several factors quickly pushed him to the to top of the list, Nemeh said: He was a child, the lung damage was irreversible and he would die without the transplant.
The surgery was performed on Oct. 15. The doctors said they could not reveal any information about the source except to say that the donor had been healthy.
Health officials investigating the outbreak described a major advance last week: Researchers found a “very strong culprit,” a form of vitamin E, in the lungs of patients who had the vaping illness. The substance, vitamin E acetate, is sometimes used by illicit sellers to “cut” or dilute THC and increase profits.
Finding the chemical in the lungs meshed with earlier investigations that had already found it in vaping products.
The vitamin compound is thick and sticky. Precisely how it might damage the lungs is not yet known, and health authorities say it is still possible that other chemicals added to vaping fluids may also contribute to lung disease.
The doctors in Detroit did not say whether vitamin E acetate had been found in the patient’s lungs.
“We’re going to see more of this,” said Dr. Mangala Narasimhan, a lung specialist at Long Island Jewish Medical Center and Northwell Health’s regional director of critical care, who has treated several severe cases of the illness. “We definitely see some patients who have such severe lung damage, we are thinking that some of it might not be completely reversible.”
None of her patients have needed transplants.
In general, lungs for transplantation are difficult to obtain, she said. “A huge number of patients die waiting.”
About 2,500 lung transplants were performed in the United States in 2018, compared with more than 21,000 kidney transplants.
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A former top executive of Juul is alleging that the electronic cigarette giant sold at least 1 million contaminated mint-flavored nicotine pods — and refused to recall them when told about the problem in March.
In a lawsuit filed in the U.S. District Court for the Northern District of California on Tuesday, Siddharth Breja, who was senior vice president for global finance, claims he was fired March 21 in retaliation for whistleblowing and objecting to the shipment of the contaminated and expired pods and other illegal and unsafe conduct that “has jeopardized and continues to jeopardize public health and safety and the lives of millions of consumers, many of them children and teens.”
Breja detailed a culture of indifference to safety and quality-control issues among top executives at the company and quoted the then-Chief Executive Kevin Burns saying at a meeting in February: “Half our customers are drunk and vaping” and wouldn’t “notice the quality of our pods.”
Burns, who left the company in September, issued a statement Wednesday afternoon strongly disputing the quote. “I never said this, or anything remotely close to this, period,” the statement said. “As CEO, I had the company make huge investments in product quality, and the facts will show this claim is absolutely false and pure fiction.”
The lawsuit was first reported by BuzzFeed News.
Ted Kwong, a Juul spokesman, dismissed Breja’s claims as baseless.
“He was terminated in March 2019 because he failed to demonstrate the leadership qualities needed in his role,” Kwong said. “The allegations concerning safety issues with Juul products are equally meritless, and we already investigated the underlying manufacturing issue and determined the product met all applicable specifications.”
This lawsuit is only the latest in a growing series of cases against Juul being filed around the country by school districts and individuals. Earlier this month a federal judicial panel gathered together the far-flung cases before Judge William H. Orrick in the Northern District of California in San Francisco, who will oversee them. The claims typically focus on personal injury for vaping-related illnesses or false marketing. The panel estimated that there are about 50 lawsuits so far.
Breja’s lawsuit did not specify what the contaminant in the nicotine pods was. The allegations detail that the shipment of tainted mint-flavored pods resulted from a series of decisions by Juul that created a huge demand for that flavor.
In November 2018, Juul, under scrutiny by the Food and Drug Administration, announced it would no longer sell its teen-friendly flavored pods in retail stores, making them available only online. But while Juul moved its dessert flavors off the shelves, it continues to sell menthol and mint in retail stores. Breja alleged that with popular flavors like mango and creme no longer readily accessible, customers began embracing menthol and mint with fervor, so much so that demand outstripped supply.
Breja said in the legal complaint that Burns, whom he characterized as behaving like an autocratic “king,” pressured suppliers to hurriedly come up with more mint-flavored product. Burns, he said, also exhorted employees, saying, “You need to have an IQ of 5 to know that when customers don’t find mango they buy mint.”
In March, Breja said he learned that batches of pods flavored with mint-flavored liquid and nicotine had been contaminated and that 250,000 “Mint Refill Kits,” the equivalent of 1 million pods, had been shipped and were being sold by retailers.
Juul did not recall the pods, Breja said, yet he was told to charge the supplier, Alternative Liquids Inc., $7 million so that Juul could recover from the contaminated batches. The supplier was not reachable for comment.
Breja said he urged Juul’s chief financial officer to issue either a recall or put out product safety warnings. A week later, the complaint says, Breja was fired.
Erika A. Kelton, a lawyer at Phillips and Cohen, a Washington-based firm that represents whistleblowers but is not representing Breja, said that although the allegations are cast as a wrongful termination case, they are likely to get the attention of regulators.
“These contamination allegations are headline-grabbing, and I’d expect both federal and state regulators will investigate because they are of such grave public concern,” she said.
Juul is already under investigation by numerous government offices, among them the Food and Drug Administration, the Federal Trade Commission, five state attorneys general and several congressional committees.
They have ordered Juul to turn over reams of internal documents, and the FDA, among others, has complained that the records do not appear complete. Breja’s case may offer a clue to their frustration.
He also claims that after the FDA raided Juul headquarters in October 2018, seeking internal documents, Burns instructed Breja and other executives not to put anything relating to regulatory or safety issues in writing, so that the FDA could not get them in the future.
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WASHINGTON - The leading American maker of electronic cigarettes, Juul Labs, announced Thursday it is suspending sales of some flavored vaping products in the United States, as the US government prepares a nationwide ban.
Juul will stop selling mango, cream, fruit and cucumber flavored pods, while federal health authorities finalize new regulations on vaping, Juul said in a statement. Its tobacco, menthol and mint-flavored products will still be available.
"We must reset the vapor category by earning the trust of society and working cooperatively with regulators, policymakers and stakeholders to combat underage use while providing an alternative to adult smokers," Juul CEO CK Crosthwaite said.
The debate over regulating e-cigarettes comes amid a mysterious epidemic of lung conditions linked to vaping that has claimed the lives of at least 33 people in 24 states.
The latest tally by the Centers for Disease Control and Prevention puts the number of confirmed or probable lung injury cases at 1,479 as of October 15.
THC, the active ingredient in cannabis, was involved in more than 3 quarters of cases in which patients reported using e-cigarettes in the 3 months prior to their injuries.
E-cigarettes have soared in popularity among young people since they were introduced about a decade ago, according to multiple surveys.
The industry defends vaping as a healthier alternative to cigarettes that can help people quit smoking. But lawmakers around the country, and overseas, are seeking to impose total or partial bans.
President Donald Trump's administration has chosen the path of barring flavored e-cigarettes, including the popular mint and menthol flavors.
Health Secretary Alex Azar announced plans for a ban in September. The text has not been made public yet but will soon be, according to the Federal Drug Administration, which is responsible for regulating tobacco and e-cigarettes.
Juul assured that it would not challenge the FDA's coming regulations, but its action Thursday indicates it believes its mint and menthol flavored products should be authorized.
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NEW YORK - New York Governor Andrew Cuomo on Sunday announced a ban on all flavored e-cigarettes besides tobacco and menthol in response to a recent nationwide spate of sometimes deadly lung illnesses that US health officials have linked to vaping.
Cuomo said vaping was dangerous and that he was concerned fruit- and candy-flavored e-cigarettes were leading young people to get hooked on nicotine.
"These are obviously targeted to young people and highly effective at targeting young people," the Democratic governor said at a news conference in Manhattan.
Nearly 400 people around the country have been stricken with a lung illness that is potentially vaping-related, according to the US Centers for Disease Control and Prevention. Six have died.
Investigators are still trying to understand what causes the illnesses. Meanwhile, health officials have warned people against buying vaping products on the street or using marijuana-derived oil. They have said people should avoid inhaling vitamin E acetate, an ingredient found in some vaping products.
In New York, the state's health commissioner, Howard Zucker, will formally ban flavored e-cigarettes besides tobacco and menthol during an emergency meeting of the state's Public Health and Health Planning Council this week, Cuomo said.
Under state law, the council can vote to issue or amend certain regulations affecting public health.
New York would be only the second state in the nation to introduce such a ban. Michigan did so earlier this month. On Wednesday, the Trump administration announced plans to remove all flavored e-cigarettes from store shelves.
Sales of e-cigarettes are banned in New York to people under 18 years old, an age that will rise to 21 in November. Cuomo said he has told state police to increase enforcement against sales to underage people.
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SHANGHAI - US e-cigarettes maker Juul Labs Inc, which faces a widening crackdown on vaping at home, has entered China, with online storefronts on e-commerce sites owned by Alibaba Group and JD.com to tap the world’s largest market of smokers.
Juul, in which tobacco giant Altria Group owns a 35 percent stake, has been launching its products in international markets such as South Korea, Indonesia and Philippines. It recently raised over $750 million in an expanded funding round.
The US government announced plans on Wednesday to remove all flavored e-cigarettes from store shelves, as officials warned that sweet flavors had drawn millions of children into nicotine addiction.
The move comes as US health officials are investigating a handful of deaths and potentially hundreds of lung illnesses tied to vaping.
A notice published on Juul's official virtual store on Tmall, an Alibaba e-commerce site, said it had opened on Sept. 9. Juul also had a similar store on JD.com, another major Chinese online retailer.
On Tmall, a Juul device with 2 flavor pods sells for 299 yuan (about $40). Flavors include mint, mango and strawberry.
Juul, Tmall and JD.com did not immediately respond to requests for comment on Thursday.
China, which is the world's largest single market for tobacco consumption with over 300 million smokers, represents a market with both opportunity and risk for the company.
It is already home to dozens of Chinese competitors with names such as Relx, Yooz, and SNOW+ that have taken tens of millions of dollars in venture capital funding from high-profile investors. Like Juul, the competitors have adopted the concept of producing discrete devices that vaporize potent nicotine salts.
China's government has perennially launched anti-smoking campaigns in an effort to improve public health. Earlier this year it released a draft document suggesting that China’s laws regulating e-cigarettes will eventually largely resemble those in Europe.
China’s tobacco industry, meanwhile, is tightly controlled by the government-run monopoly China Tobacco, which maintains complete oversight on the sale, production and distribution of tobacco products. Beijing relies on tobacco sales for a sizable percentage of China’s overall tax revenue.
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LOS ANGELES - San Francisco on Tuesday became the first major US city to effectively ban the sale and manufacture of electronic cigarettes, as concerns grow over a sharp rise in vaping among youths.
The city's legislature unanimously approved an ordinance suspending the sale in shops or online of e-cigarette products that lack approval by federal health authorities. No such approvals currently exist.
Backers said the ban was necessary due to the "significant public health consequences" of a "dramatic surge" in e-cigarette use among teenagers.
But the move triggered a swift backlash from critics who say it could drive former smokers back to conventional cigarettes.
US health authorities are alarmed by the rise in popularity of e-cigarettes, battery-powered devices that enable users to inhale addictive nicotine liquids that are often fruit flavored.
The potential health consequences of vaping, including fears it could stunt adolescent development, remain largely unknown, in part because the practice is so new.
The number of young Americans using e-cigarettes grew by 1.5 million in 2018, with about 3.6 million middle and high school students using vaping products.
San Francisco is home to market-leading e-cigarette maker Juul.
City Attorney Dennis Herrera, who co-sponsored the ban, said it closed a loophole that the federal U.S. Food and Drug Administration should have tackled long ago.
"E-cigarettes are a product that, by law, are not allowed on the market without FDA review," he said in a statement after the second and final vote to implement the ban.
"For some reason, the FDA has so far refused to follow the law. If the federal government is not going to act, San Francisco will."
'DEADLY CIGARETTES'
The city's mayor London Breed has 10 days to sign the legislation -- which she has said she will do -- with the ban due to take effect seven months later.
"We need to take action to protect the health of San Francisco's youth and prevent the next generation of San Franciscans from becoming addicted to these products," Breed said in a statement Tuesday ahead of the vote.
She added that e-cigarette companies were "targeting our kids in their advertising and getting them hooked on addictive nicotine products."
But critics say the legislation will make it harder for people seeking alternatives to regular cigarettes.
E-cigarettes do not contain the cancer-causing products found in tobacco.
An editorial in the Los Angeles Times noted that regular cigarettes were still for sale in San Francisco, arguing that "it's bad public health policy to come down harder on the lesser of two tobacco evils."
Juul said in a statement following the vote that the ban would "drive former adult smokers who successfully switched to vapor products back to deadly cigarettes, deny the opportunity to switch for current adult smokers, and create a thriving black market."
The manufacturer called instead for stricter regulation and enforcement including proof-of-age identification.
'INCREASE RISK'
Traditional "Big Tobacco" companies have increasingly marketed "smoke-free" products like e-cigarettes as far less harmful alternatives to the deadly habit they have long been peddling.
But experts point out that it took decades to determine that smoking tobacco -- which accounts for more than seven million premature deaths worldwide every year -- is truly dangerous.
The San Francisco ordinance text said that nicotine exposure during adolescence "can harm the developing brain" and "can also increase risk for future addiction to other drugs."
It would introduce fines of up $1,000 for each violation by vendors.
Unlike an e-cigarette ban in force in Singapore, the San Francisco legislation does not restrict the use of vaping products -- only sales, manufacturing and distribution.
Recreational cannabis use has been legal for adults in California since January last year.
amz-ban/ft
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