Washington, May 16 (AP/UNB) — A federal judge is siding with public health groups suing the Food and Drug Administration to begin reviewing thousands of e-cigarettes on the U.S. market.
The ruling handed down Wednesday in district court states that the agency shirked its legal duty when it postponed reviewing all U.S. vaping products by several years.
The American Academy of Pediatrics, Campaign for Tobacco-Free Kids and other groups filed the federal lawsuit in Maryland last year. The groups say the lack of FDA oversight has led to an explosion in underage vaping by teenagers, threatening to hook a generation of Americans on nicotine.
"It is now the FDA's responsibility to take immediate action to protect our kids and require manufacturers to apply to the FDA if they want to keep their products on the market," the groups said in a statement.
E-cigarettes are nicotine-emitting devices that have grown into a multibillion-dollar industry in the U.S. despite little research on their long-term health effects, including whether they are useful in helping smokers quit cigarettes.
The FDA gained authority to regulate the products in 2016, but it has allowed thousands of products to remain on the market without formal rules or product standards. The agency says that both FDA staff and manufacturers need more time to prepare for regulation.
The public health groups have warned that the lack of oversight could undo decades of anti-tobacco efforts as young people migrate toward newer vaping products.
U.S. Judge Paul Grimm agreed, calling the FDA's delay "so extreme as to amount to an abdication of its statutory responsibilities."
FDA spokesman Michael Felberbaum said in an emailed statement that the agency is reviewing the court decision and "will continue to tackle the troubling epidemic of e-cigarette use among kids." The agency will have the option of appealing the decision.
Gregory Conley of the American Vaping Association said the government "must appeal this ruling" to "protect adult access to less harmful alternatives to cigarettes."
Under President Donald Trump's FDA commissioner, Scott Gottlieb — who departed last month — the FDA said it would not require e-cigarette manufacturers to submit their products for review until 2022. Shortly before stepping down Gottlieb moved the deadline up to 2021.
But Grimm's ruling suggests the FDA must move much faster. He calls for the health groups and the FDA to submit plans for moving forward with product reviews within 30 days.
Wednesday's ruling follows a similar decision last September, when a federal judge said the FDA must move ahead with adding graphic warning labels to cigarette packs. The FDA was required to take that step under a 2009 law, but the process has been bogged down by legal challenges from tobacco companies.
"The courts are clearly pushing FDA — at behest of medical and consumer groups — to step up their regulatory pressure on industry," said Marc Scheineson, a former FDA official who now advises companies with the law firm Alston & Bird.
Scheineson said he expects the FDA to argue that it doesn't have the resources to process the flood of applications that industry would submit if the ruling is enforced.
The FDA and most health experts agree that e-cigarettes are likely less harmful than traditional cigarettes because they don't produce the cancer-causing byproducts of burning tobacco. But there is little research on their long-term health effects, particularly for young people.
Nicotine is what makes both cigarettes and e-cigarettes addictive, and health experts say the chemical is harmful to developing brains.
Separately on Wednesday, North Carolina's attorney general announced the first state lawsuit against e-cigarette giant Juul, which dominates the U.S. vaping market.
While living in a mother’s womb, cushioned by amniotic fluid and protected from the outside world, babies have only minimal exposure to microorganisms like bacteria and viruses. Shortly after birth, a newborn’s collection of microorganisms – their microbiome – begins to develop as a succession of bacteria colonizes their gut.
A variety of factors, such as mode of delivery (cesarean or vaginal birth) and antibiotic use, influence this population of bacteria. After that, human milk serves as a primary way more bacteria are introduced to a baby’s system, as it can contain up to 700 different species of bacteria.
In my research as a chemist, I’ve been focusing on the complex sugars that human milk contains. My colleagues and I are interested in how these sugar molecules help mold a baby’s microbiome and contribute to overall health. Ultimately we hope that knowing more about individual molecules in human breast milk will lead to the development of better infant formulas that can be used in cases where breastfeeding isn’t possible.
What’s in mother’s milk
You’ve probably heard that breast milk provides all the energy requirements, vitamins and nutrients that an infant needs. In fact, the World Health Organization recommends exclusively breastfeeding babies for the first six months of life when possible. Unfortunately there are a number of reasons that breastfeeding can be a challenge to keep up; and indeed, only about a quarter of American babies meet that guideline.
Breastmilk has a number of health benefits, beyond just keeping a baby well-fed. Exclusively breastfed babies have lower infant mortality due to common childhood illnesses such as diarrhea, pneumonia, urinary tract infection, ear infection, necrotizing enterocolitis and sudden infant death syndrome (SIDS), compared to formula-fed counterparts. And antibodies in milk mean breastfeeding helps babies recover quicker when they do fall ill.
Researchers know human milk contains two types of simple proteins, whey and casein, which are easily digested. It also has complex proteins including lactoferrin, which inhibits the growth of iron-dependent bacteria, and secretory IgA, which protects the infant from viruses and pathogenic bacteria. It provides a number of essential fats that are necessary for brain development, vitamin absorption and nervous system development.
And then there are the complex sugars called human milk oligosaccharides or HMOs that have long been neglected by the scientific community. As trained organic chemists, my team took an interest in HMOs precisely because not much was known about them. A few studies had found that these sugars were food for good bacteria, but not the pathogenic ones. It seemed like there must be more to the story. We also knew we’d be able to synthesize in the lab any molecules we identified as important.
A closer look at mom’s milk sugars
These complex sugars in human milk appear to provide a growth advantage for good bacteria. For example, breastfed infants have a microbiome rich in two species of bacteria: Bacteroides and Bifidobacteria. Both species are symbiotes, meaning they live with us on a daily basis, but typically cause no harm. They live in the human gut where they use human milk oligosaccharides as energy sources to grow, whereas pathogens do not. Breastfed babies tend to be colonized to a lesser extent by infectious species, meaning they get sick less.
Many of the protective properties of human milk have been attributed to its HMO component. For instance, research has shown that HMO supplementation shortens the duration of rotavirus infection – one of the leading causes of diarrhea in infants.
Bovine milk, which most formula is based on, however, contains a negligible oligosaccharide component. Additionally, bovine milk oligosaccharides lack the structural complexity and diversity of HMOs. So formula-fed infants do not obtain comparable oligosaccharide-fostered protections to those who are breastfed.
A case study: Group B strep
Based on these known effects of human milk oligosaccharides, my research group took an interest in Group B streptococcus. All mothers-to-be are screened during the third trimester of pregnancy for Group B strep; although it isn’t much threat to a healthy adult, this bacteria can be passed to the baby during labor and birth, with an increased risk of infection.
We noted that, even though Group B strep bacteria are present in breast milk, children who breastfeed are not at increased risk for Group B strep infection. Why? Could HMOs be providing protection against this bacteria?
To investigate, our team worked to isolate the complex sugars contained in donated human milk. With these molecules in hand, we began to test whether HMOs acted as antibiotics against Group B strep. In an initial study, we tried to grow Group B strep both in the presence and absence of HMOs. It turned out that HMOs do prevent the growth of Group B strep bacteria.
We also observed that different women produced HMOs with varying levels of antibiotic activity. This was not surprising as there are over 200 different HMOs in breast milk. Every woman produces a different set of sugars and they change during lactation. In followup studies, we showed that HMOs have antibiotic properties against a number of additional pathogens, including staph.
Going forward, our goals are to figure out exactly how these sugars are working and why specific women produce sugars that are more antimicrobial than others. Once researchers understand more about which HMOs are the most important ingredients in breast milk for baby health, these compounds can be synthesized and added to infant food products. A better quality infant formula that more closely mimics human breast milk may help close the health gap between breastfed and formula-fed babies.
Los Angeles, May 9 (AP/UNB) — The nation's most productive agricultural state moved Wednesday to ban a controversial pesticide widely used to control a range of insects but blamed for harming brain development in babies.
The move cheered by environmentalists would outlaw chlorpyrifos after scientists deemed it a toxic air contaminant and discovered it to be more dangerous than previously thought. California Environmental Secretary Jared Blumenfeld said it's the first time the state has sought to ban a pesticide and the move was overdue.
"This pesticide is a neurotoxin, and it was first put on the market in 1965," Blumenfeld said. "So it's been on the shelf a long time, and it's past its sell-by date."
The decision comes after regulators in several states have taken steps in recent years to restrict the pesticide used on about 60 different crops in California, including grapes, almonds and oranges. Hawaii banned it last year, and New York lawmakers recently sent a measure to the governor outlawing use of the pesticide.
DowDuPont, which produces the pesticide, said it was disappointed with the decision and that farmers who rely on the pesticide say it will hurt their ability to control insects.
"It's a very important part of the crop protection tool box," said Casey Creamer, president of California Citrus Mutual, which represents 5,000 growers. "We're fighting for our lives here trying to protect ourselves from deadly diseases, and we keep losing tools."
Creamer questioned the scientific studies behind the decision and said removing the pesticide could hurt efforts to prevent a pest like the Asian citrus psyllid from decimating the citrus industry in California like it did in much of Florida. The pest infects citrus trees with a fatal disease.
Blumenfeld said California took action in part because the federal government allowed the pesticide to be used after the Obama administration tried to phase it out.
The U.S. Environmental Protection Agency under President Donald Trump reversed that effort after reevaluating the science. Environmental groups and farmworkers challenged that decision, and a federal appeals court last month ordered the EPA to decide by July whether to ban the pesticide.
"This is a historic victory for California's agricultural communities and for children nationwide," said Miriam Rotkin-Ellman of the Natural Resources Defense Council. "The science clearly shows that chlorpyrifos is too dangerous to use in our fields. Since California uses more chlorpyrifos than any other state, this ban will not only protect kids who live here, but kids who eat the fruits and veggies grown here."
The pesticide is in a class of organophosphates chemically similar to a nerve gas developed by Nazi Germany before World War II. Its heavy use has often left traces in drinking water sources. A 2012 study by the University of California, Berkeley, found that 87% of umbilical-cord blood samples tested from newborn babies contained detectable levels of the pesticide.
Dr. Gina Solomon, a medical professor at the University of California, San Francisco, and former deputy secretary of Cal-EPA, said chlorpyrifos is unusual in that it's one of the best understood pesticides because it's been so extensively studied.
"We know a lot about what it does to developing children, and that science is the bedrock of the action that Cal-EPA is announcing," she said. "Many pesticides have been studied well in lab rats, but in this case, we actually know what it does to people."
Studies in cities where the pesticide was once used to kill cockroaches before it was banned for indoor use in 2000 and in rural farmworker communities showed it harmed brain development in fetuses and affected reading ability, IQ and led to hyperactivity in children, Solomon said. Even head sizes were smaller in children whose mothers were exposed to the pesticide.
While the ban — technically known as a cancellation — could take up to two years to take effect, the state Department of Pesticide Regulation has recommended that county agriculture commissioners adopt stricter rules on where and how the chemical can be applied, including larger buffer zones.
Use of the pesticide has been reduced by more than half in California since 2005, to just under 1 million pounds (450,000 kilograms) used on crops in 2016, the state says.
To help farmers make the transition away from chlorpyrifos, California is adding contributing $5.7 million to the development of safer alternatives.
While most environmental groups applauded the announcement, Earthjustice said it would continue pushing legislation to ban the chemical because it questions whether the Department of Pesticide Regulation will follow through.
"It's been like pulling teeth to force DPR to begin the cancellation process for chlorpyrifos," said Greg Loarie, an Earthjustice attorney. "Until we know that chlorpyrifos is gone for good, we are going to keep pushing as hard as we can in as many places as we can."
Shanghai, May 8 (AP/UNB) — The sound of doctors boring through his skull to feed electrodes deep into his brain made Yan tremble.
"The drill was like bzzzzzzz," he later recalled. "The moment of drilling is the most terrible."
Yan is a methamphetamine addict. The hope is that technology will extinguish his addiction — quite literally, with the flip of a switch.
The treatment — deep brain stimulation — has long been used for movement disorders like Parkinson's. Now, the first clinical trial of DBS for methamphetamine addiction is being conducted at Shanghai's Ruijin Hospital, along with trials for opioid addicts. Yan is the study's first patient; for fear of losing his job, he asked that only his surname be published.
Western attempts to push forward with human trials of deep brain stimulation for drug addiction have foundered, even as China has emerged as a hub for this kind of research.
But the vast suffering wrought by the U.S. opioid epidemic may be changing the risk-reward calculus for doctors and regulators. Now, the experimental surgery Yan underwent is coming to America. In February, the U.S. Food and Drug Administration greenlighted a clinical trial in West Virginia of DBS for opioid addicts.
Until now, complex ethical, social and scientific questions made it hard to push forward with such experiments in the United States, where the devices can cost $100,000 to implant. Scientists in Europe have struggled to recruit patients for their DBS addiction studies.
Globally, there are eight registered DBS clinical trials for drug addiction, according to a U.S. National Institutes of Health database. Six are in China.
China has a long, troubled history of using brain surgery to treat addiction. Doctors destroyed small clumps of tissue in the brains of heroin addicts, garnering huge profits and leaving behind a trail of patients with mood disorders, lost memories and altered sex drives.
In 2004, China's Ministry of Health ordered a halt to the practice at most hospitals. Nine years later, a military hospital in Xi'an reported that roughly half of 1,167 addicts who had their brains lesioned stayed off drugs for at least five years.
DBS builds on that history. The surgery involves implanting a device that acts as a kind of pacemaker for the brain, electrically stimulating targeted areas. Instead of irreversibly killing brain cells, the devices allow interventions that are — in theory — reversible. The technology has opened a fresh field of human experimentation globally.
"For many other psychiatric disorders, for example, anorexia schizophrenia, OCD, there's no way to use the animal to be like a model," said Dr. Sun Bomin, director of the functional neurosurgery center at Ruijin Hospital. "For these kinds of special psychiatric disorders we have to use human patients."
Some believe such human experiments on drug addicts should not be allowed.
Critics argue that they are premature, and will not address the complex biological, social and psychological factors that drive addiction. Scientists don't fully understand how DBS works and there is still debate about where electrodes should be placed to treat addiction. There is also skepticism in the global scientific community about the general quality and ethical rigor of clinical trials done in China.
"It would be fantastic if there were something where we could flip a switch, but it's probably fanciful at this stage," said Adrian Carter, who heads the neuroscience and society group at Monash University in Melbourne. "There's a lot of risks that go with promoting that idea."
Meanwhile, the body count from addiction is rising. More than 500,000 Americans died of drug overdoses in the decade ending in 2017, adding urgency to the search for new, more effective treatments.
But research for DBS as an addiction treatment funded by the U.S. National Institutes of Health has focused on animals, not people. And at least two U.S. laboratories dropped clinical trials of DBS for treating alcoholism over concerns about study design and preliminary results that didn't seem to justify the risks, investigators who led the studies told The Associated Press.
"The lack of scientific clarity, the important but strict regulatory regime, along with the high cost and risk of surgery make clinical trials of DBS for addiction in the U.S. difficult at the present time," said Dr. Emad Eskandar, chairman of neurological surgery at Albert Einstein College of Medicine in New York.
China's studies have offered mixed results. Sun and his colleagues have published one case study, describing a heroin addict who fatally overdosed after getting DBS. But a separate pilot study published in January by doctors at a military hospital in Xi'an showed that five of eight heroin addicts stayed off drugs for two years after DBS surgery.
Based on those results, the Chinese deep brain stimulation device manufacturer SceneRay Corp. is seeking Chinese regulatory approval of its DBS device for addiction, and funding a clinical trial targeting 60 heroin addicts. SceneRay chairman Ning Yihua said his application for a clinical trial in the U.S. was blocked by the U.S. Food and Drug Administration.
But in February, the FDA greenlighted a separate trial of DBS for four opioid addicts. The study lead, Dr. Ali Rezai, director of the West Virginia University Rockefeller Neuroscience Institute, hopes to launch the trial in June.
"People are dying," Rezai said. "Their lives are devastated. It's a brain issue. We need to explore all options."
Yan is among those whose lives have been ravaged. Years of drug use cost him his wife, his money and his self-respect, before landing him at Ruijin Hospital in search of a radical cure.
After surgery, Yan said the machine in his brain was magical. "It controls your happiness, anger, grief and joy," he said.
More than six months later, he says he is still off drugs and has put on 20 pounds. Sometimes, in his new life, he touches the hard cable in his neck that leads from the battery pack to the electrodes in his brain. And he wonders: What is the machine is doing inside his head?
Dhaka, Apr 30 (UNB) - Other than Crimson Cup Coffee & Tea, if there is any place in Dhanmondi buzzing with students for a quick meal or snack break, it has got to be The SweetSin Coffees! Regardless of what time you pick to pay them a visit, it’s always buzzing with youngsters hanging out over waffle, coffees, or their great lunch platters!
Last week, an old friend rung up for a few of us to catch up over lunch but we were all on a budget (student troubles). I had been to SweetSin plenty of times before and knew that this place would be suitable both in terms of taste and price. We were greeted warmly by one of their servers and took couch seats by the window which provides a beautiful view of Dhaka City. We ordered 2 Teriyaki Chicken Platters and 1 Sirloin Beef Platter.
At BDT 485+, I was surprised when they asked us for the doneness of the beef steak and of course, I had replied back with a medium. We were served within 15 minutes and my friends were blown away with the portion of each of the platter. The dishes came with sides of rice, sautéed veggies, fresh salad, and mashed potato.
While the plating was a mess, the Teriyaki Chicken tasted scrumptious! It was juicy, tender, and slightly charred. The Japanese rice tasted more like a Mexican one with plenty of peppery taste at every bite. It went really well with the chicken which had a sweet and sour taste from the soy sauce mixed with honey. Moreover, the chicken even had sesame seeds sprinkled on top just like any Teriyaki dishes served at restaurants and added a certain nutty flavor to the chicken. The salad consisted of purple cabbage, carrots, and tomatoes while the sautéed veggies were carrots, broccoli, long beans, and cauliflower cooked with butter, salt, and pepper. The mashed potato could have used some more cream/milk. However, for the price I was paying, I was just glad I wasn’t asked to choose between rice or mash since I was starving!
The beef steak on the other hand was slightly disappointing as the amount of black pepper used here gave too much of a sharp taste. It was because of the mashed potato that (when paired with the steak) helped mellow down the sharpness and allowed us to enjoy the steak. The sides were the same that came with the chicken platter but since this dish was a beef steak, my friend was unable to finish the entire platter by herself.
Why I recommend The SweetSin Coffees is because of the quantity you get for the price you pay. As student, it has become increasingly difficult to find a place for a proper meal these days without paying a hefty price. SweetSin might still come off as slightly more expensive but the service, view, and ambience you get for the price, it is definitely one place I end up going to every now and then.
By: Ifreet Taheea