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FDA expediting use of a blood plasma coronavirus treatment as New York rolls out new clinical trials


The FDA said in a news release that it is “facilitating access” for patients with life threatening infections to blood plasma taken from a person who recovered after once testing positive for the virus.

It’s a treatment the state of New York is pursuing in clinical trials, Gov. Andrew Cuomo said Tuesday.

The process, known as plasma-derived therapy or “convalescent plasma,” involves doctors testing the plasma of people who recovered for antibodies to the virus and then injecting that plasma, or a derivative of it, into the sick person.

The move is a “big step” forward, said Dr. Arturo Casadevall, chief of molecular microbiology and immunology at Johns Hopkins Bloomberg School of Public Health, who has advocated for the plasma treatment.

“It has a high likelihood of working but we won’t know whether it works until its done” and enough patients have been treated, he said. “We do know based on history it has a good chance.”

Rolling out trials

The move comes as the US recorded its deadliest day since the outbreak began. More than 150 deaths from Covid-19, the disease caused by coronavirus, were reported in the US on Tuesday, according to a tally by CNN. At least 700 people in the US have died and more than 53,000 have tested positive for the virus.

Cuomo said his state is also pursuing testing people’s blood for antibodies and immunity to coronavirus.

“That would be very important for us to know because then healthcare workers that could go back to work, there are workers that could return back to the private sector.”

The New York State Department of Health is also rolling out clinical test trials for anti-malaria drug Hydroxychloroquine and the antibiotic Azithromycin. The patients who are hospitalized with moderate or severe coronavirus will be eligible to receive the treatment.

“Those are the patients that we think can have the greatest impact so we want to focus on them,” according to a New York health official.

A second New York University trial is exploring if Hydroxychloroquine can be used as a preventative measure to preemptively treat people who don’t have the virus but are in contact with those who do, according to an email seen by CNN that was sent by a member of the NY Health Department’s Institutional Review Board.

Logistics are the biggest issue

The New York health official said for the plasma treatment they will be recruiting patients from New Rochelle, which had the first cluster of cases in the state and now has a critical mass of people who have recovered.

Plasma treatments will take time to get off the ground.

Physicians will need to identify patients who now test negative for the disease, extract their plasma and have it tested for antibodies for Covid-19 before it can be deployed to ill patients. If there are enough antibodies in plasma it can kill the disease, some doctors say.

The FDA is limiting the plasma treatment to the most seriously ill patients.

The New York health official acknowledged finding a good candidate and providing plasma could take days, but the official said they are expediting this process to just a few days.

“The biggest issue is the logistics. You’ve got to find the people, you’ve got to test them, identify the right donors, donate plasma and get it to the people who need it. That involves logistics but it’s all doable we’re not talking about rocket science,” said Casadevall. He says he’s been overwhelmed with people who want to donate their plasma and doctors around the world who want to understand the potential treatment.

Casadevall has set up a website where he hopes to post more information in the next few days.

Plasma treatments have been used since 1900s

He anticipates doctors could know in as soon as one month whether the plasma treatment is working if they get enough volunteers to donate their plasma.

How we've overcome past pandemics

Plasma treatments have been used since the 1900s to treat infectious diseases like influenza and more recently Ebola. China has used this treatment in its Covid-19 positive patients and says it is working although US doctors have not yet seen the underlying data.

Casadevall said it’s largely safe but there are always risks, including whether someone passes along a pathogen that wasn’t identified earlier.

He said the treatment might not work if the patients are too critical. In 2009, he said, there was a trial to treat influenza using plasma but some of the patients were already too sick for the antibodies to work. He said their dire situation had less to do with the virus and more to do with inflammation.

In New York, he said, the treatment will be given to people who are already very ill, but he hopes it will get to the point where doctors can prescribe it to patients who are diagnosed much earlier.



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US cigarette packs and ads to include graphic warnings, FDA says



Beginning on June 18, 2021, the new cigarette health warnings will be required on cigarette packages and in advertisements, occupying the top 50% of the area on the front and back panels of packages and at least 20% of the area at the top of cigarette ads, according to the FDA.

“The 11 finalized cigarette health warnings represent the most significant change to cigarette labels in more than 35 years and will considerably increase public awareness of lesser-known, but serious negative health consequences of cigarette smoking,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a news release on Tuesday.

“Research shows that the current warnings on cigarettes, which have not changed since 1984, have become virtually invisible to both smokers and nonsmokers, in part because of their small size, location and lack of an image. Additionally, research shows substantial gaps remain in the public’s knowledge of the harms of cigarette smoking, and smokers have misinformation about cigarettes and their negative health effects,” Zeller said. “The new cigarette health warnings complement other critical FDA actions, including outreach campaigns targeted to both adults and youth, to educate the public about the dangers associated with using cigarettes, as well as other tobacco products.”

The proposed warnings feature color images and describe the health risks of smoking, warning, “Smoking reduces blood flow to the limbs, which can require amputation,” and “Smoking causes bladder cancer, which can lead to bloody urine.”

Various health groups — the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids and the Truth Initiative — responded to the final rule in a written statement.

“The U.S. Food and Drug Administration today has taken a critical and long-overdue step forward in the nation’s battle against tobacco use — the number one cause of preventable death,” the statement said in part. “The new warnings show and tell the truth about the deadly consequences of smoking and will promote greater public understanding of the many ways in which smoking harms the human body.”

R.J. Reynolds Tobacco Company, which is among the tobacco companies impacted by this FDA rule, issued a statement in response on Tuesday.

“We support the goal of reinforcing and sustaining the near universal public awareness of the dangers of smoking, but attempting to shock cigarette smokers away from making an informed choice through the use of grotesque pictorial warnings is poor public health policy as well as an unconstitutional violation of free speech,” Kaelan Hollon, a spokesperson for Reynolds American Inc., said in the emailed statement. Reynolds American is the parent company of R.J. Reynolds Tobacco Company in the United States.

“We firmly support public awareness of the harms of smoking cigarettes, but the manner in which those messages are delivered to the public should comply with First Amendment protections that apply to all speakers, including cigarette manufacturers,” the statement said. “Publication of the comparative risks of other tobacco products by FDA to the public is imperative, so that adults who wish to continue to use them can make fully-informed decisions between product options in the tobacco category. We are evaluating our options and will communicate next steps soon.”



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Special Report: FDA targets e-cigs that hook teens but don’t help smokers quit


(Reuters) – E-cigarette makers face an existential threat. By May, they must submit applications to the U.S. Food and Drug Administration proving that their products provide a net benefit to public health. If a company fails to make its case, the FDA has the power to order its products off the market.

FILE PHOTO: Signage for Juul vaping products is seen on a storefront in New York City, U.S., September 9, 2019. REUTERS/Andrew Kelly/File Photo

The agency will judge that benefit with a two-part test: Are e-cigarettes effective in getting smokers to quit? And, if so, does that benefit outweigh the health damage to new e-cigarette users – including teenagers – who never smoked in the first place?

That’s a particularly high hurdle for the largest e-cigarette maker, Juul Labs Inc, according to a Reuters analysis of the latest available data on trends in cigarette and e-cigarette use from the U.S. Centers for Disease Control and Prevention.

The data show that e-cigarettes are having little impact in reducing U.S. cigarette smoking, while growth in vaping since 2015 has come entirely from users under 25 years old, including teenagers. Those trends present a special problem for Juul because of its dominance of the U.S. market and its enormous popularity among teenagers, according to more than a half dozen tobacco researchers and medical experts who assessed the data at Reuters’ request.

“I don’t see it as a surmountable hurdle,” Suzanne Colby, a tobacco researcher at Brown University, said of the FDA standard for public health benefits. “The data look like their product differentially attracts youth instead of adults, in such great numbers.”

Between 2017 and 2018 – the period when Juul rapidly grew to become the U.S. market leader – e-cigarette use among U.S. adults grew from 2.8% of the population to 3.2%, according to the CDC. But rates of cigarette smoking among adults barely budged, dropping from 14% to 13.7% – not enough to be statistically significant, according to the CDC. (For a graphic showing vaping trends for various age groups, see: here )

Use of e-cigarettes by high-school students, by contrast, shot up by 78% over the same period – from 11.7% to 20.8% of students, data from the CDC and the FDA show. Juul is by far the most popular e-cigarette among teens, with more than half of high school and middle school students naming it as their favorite brand in surveys by the CDC and the FDA.

Moreover, the biggest growth in adult e-cigarette use came among the youngest age cohort of adults, people aged 18 to 24. E-cigarette use among young adults is nearly four times more common than among those aged 45 to 64, the CDC numbers show.

Another dynamic that undermines the public-health case for e-cigarettes is the large proportion of “dual users.” The most recent federal data show that 41% of adult e-cigarette users continue to also smoke cigarettes.

Some studies show dual use could be more harmful than smoking alone. A study last December found people who used both products tested higher than cigarette smokers for a range of volatile organic compounds and other toxins associated with tobacco-related disease. A separate study last year of heart disease risk among e-cigarette users found that dual use was “more dangerous than using either product alone.”

For the industry as a whole, the usage data cast serious doubts on whether e-cigarettes are providing a clear benefit among adult smokers, said Brian King, a deputy director at the CDC’s Office on Smoking and Health.

“When it comes to net public health impact, you have to consider both ends of the scale,” King said. “Right now it does appear the youth initiation is outweighing the adult use.”

Juul declined a request for an interview with executives including CEO K.C. Crosthwaite, a veteran of Marlboro maker Altria Group Inc who took the helm in September, on how it plans to pass the FDA’s regulatory test. As pressure on the company has mounted, Crosthwaite has made the FDA application process a central goal, laying off 650 employees, including many in marketing, last month in an effort to restructure the company to focus on regulatory approval.

In written responses to questions from Reuters, Juul said it believes its products “already are playing a critical role in transitioning adult smokers from combustible cigarettes and have the potential to convert tens of millions of smokers in the U.S.” The company cited studies it has commissioned showing that between 30% to 50% of adult smokers who use Juul “switch completely from smoking cigarettes within six months.”

Juul has said its customers are “the world’s 1 billion smokers,” but the company did not directly address questions about the disparity in youth and adult uptake in the United States. Juul acknowledged it must address any potential impact on nonsmokers who start using e-cigarettes. It said it is “committed to working cooperatively with regulators, public health officials and other stakeholders to combat underage use and convert adult smokers.”

In October, Crosthwaite brought on another Altria executive, Joe Murillo, who helped navigate a successful FDA application for IQOS, a Phillip Morris International Inc product that heats up but doesn’t burn packages of ground-up tobacco. Altria has an agreement with Philip Morris to market IQOS in the United States. The IQOS device is one of only two tobacco products that have successfully made it through the FDA process.

Juul’s competitors in the U.S. market face the same regulatory challenge. One rival, Japan Tobacco International, says it is confident in the FDA application it filed in August for its Logic products because it contains company data showing the brand – unlike Juul – is used overwhelmingly by older adults.

Anthony Hemsley, an executive for Japan Tobacco International’s U.S. division, acknowledged the population-wide trends in e-cigarette and cigarette use. But he pointed out that the FDA’s decision on net public health benefit will be made on a product-by-product basis – not across the entire industry. He added that Juul has “a significant challenge ahead of them, in overcoming the concerns that exist out there.” 

The FDA declined requests for an interview with Mitch Zeller, who heads tobacco regulation at the agency, about its oversight of e-cigarettes. In written answers to questions, the agency did not directly address the population-level data on smoking and vaping trends but said it is “tasked with threading a public health needle” in crafting regulations on e-cigarette firms.

A Reuters investigation in November detailed how Juul’s developers used tobacco industry research and patents to formulate its smooth but potent “nicotine salts” blend of liquid nicotine, a key factor in its popularity among teenagers. The report showed company leaders were aware of the product’s popularity among teenagers soon after its 2015 launch, contradicting statements that Juul was caught off guard by teenage use last year.

Former FDA Commissioner Scott Gottlieb told Reuters that he agreed with public health advocates and tobacco researchers that whatever benefits Juul may be having for cigarette smokers are offset by attracting children who otherwise wouldn’t have tried other tobacco products. Before Gottlieb left the department in April, he and his staff explored the option of halting sales of Juul and similar high-nicotine devices if their popularity continued rising among teens.

“We could take these products off the market tomorrow,” he said. “We don’t need the applications.”

(For a graphic tracking the rise of vaping amid regulatory delays, see: here)

Juul and the FDA did not respond to questions on Gottlieb’s assertion that the agency should immediately remove Juul and similar products from the market.  

MOUNTING PRESSURE ON THE FDA

E-cigarettes have been available in the United States since at least 2007, but the FDA did not formally get authority over the industry until nine years later, in 2016.

The agency initially tried to regulate e-cigarettes as a drug, which would have carried more stringent requirements for e-cigarette firms, such as extensive clinical trials or animal testing. E-cigarette makers sued the FDA and won, leaving the agency to regulate the devices as tobacco products.

FDA officials started crafting a rule to regulate e-cigarettes in 2011, but the industry pushed back and successfully delayed the rule until May 2016, in the final months of the administration of President Barack Obama. During that time, Juul and dozens of competitors introduced products that were grandfathered into the market because they were already being sold before the regulation took effect.

The rule extended certain cigarette restrictions to e-cigarettes, like requiring health warning labels, setting a minimum sales age of 18 and prohibitions on free samples.

A key part of the new rule also required e-cigarette makers to submit applications to the agency by August 2018 – demonstrating why their products provide a net benefit to public health – along with studies and data on potential toxins in the products.

When Gottlieb was appointed by President Donald Trump to lead the agency in 2017, one of his first moves was to delay that deadline by four years, a decision public health advocates criticized. Just months later, school administrators, parents and politicians raised alarms about the rapid rise of vaping among high schoolers, who were particularly transfixed with the Juul device.

Some public health advocates feared the new administration’s commitment to the Obama-era regulations after an initial three-month delay, as the FDA faced litigation from the industry. Gottlieb declined to comment  on whether the some in the administration wanted to kill the regulations but said his effort to push them forward was “not an easy process.” He said he delayed the deadline because the previous administration had not drafted guidelines that companies could follow for the application process, leaving the agency open to a legal challenge from the regulated industries.

“They would have sued me, and I would have lost,” he said.

But today’s FDA could – and should – pull Juul and other products from the market, Gottlieb said.

“I thought that’s where the agency would land,” he said.

In March, just before he left the agency, Gottlieb said publicly that the FDA was considering prohibiting sales of cartridge-based e-cigarettes like Juul from the market if teen usage rates went up for a second year in a row. Federal youth tobacco survey data first released in September showed that teenage usage did in fact keep rising, with the percentage of teenagers reporting they used e-cigarettes in the last 30 days growing from nearly 21% to more than 27%.

Slideshow (2 Images)

In a statement, the FDA said it has sent more than 1,100 warning letters to retailers selling to minors; issued warning letters to companies marketing teen-friendly e-cigarette products, such as those with sweet flavors; and launched advertising campaigns aimed at e-cigarette prevention in schools.

“Taken together, all of these efforts have had a wide-ranging impact on the manufacturing, marketing and selling” of e-cigarettes, the agency said. “FDA’s work is constant in its effort to keep these products out of the hands of kids.”

Reporting by Chris Kirkham; Editing by Vanessa O’Connell and Brian Thevenot



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