Review Category : Health

New FDA Regulations Won’t Slow Down Big Tobacco, Analysts Say

iStock/Thinkstock(NEW YORK) — Major regulations for e-cigarettes and tobacco products announced this week may not do much to slow down the largest tobacco companies, analysts tell ABC News.

E-cigarettes will face new regulations by the U.S. Food and Drug Administration (FDA), including requirements that affect manufacturing, ingredient labeling and not selling the product to those under the age of 18, the agency announced Thursday.

In addition, California Gov. Jerry Brown signed legislation yesterday prohibiting the sale of cigarettes to anyone under age 21, up from 18, and restricting the use of e-cigarettes in public places in the state. The state also reclassified vapor products as tobacco.

The FDA’s rules will especially affect the businesses of smaller e-cigarette makers, which may not have the resources to comply with the agency’s approval process, said Michael Lavery, an analyst with Credit Lyonnais Securities Asia (CLSA) Americas in New York. Lavery said that “could be a positive” for larger tobacco companies, such as Altria Group, Reynolds-American and Imperial Brands, he wrote in a research note shared with ABC News. E-cigarettes currently make up less than 1 percent of revenue for all three companies, he noted.

In response to the FDA’s regulations, Stifel analyst Chris Growe, who follows the tobacco industry, said the larger tobacco companies are already accustomed to numerous laws governing their products.

“We believe the large tobacco companies can thrive in a heavily regulated world, such as the current conditions in the cigarette category,” Stifel analyst Chris Growe wrote in a research note provided to ABC News. “In addition, the level of regulation will be so high that small companies, those typically operating in the E-cig category and other tobacco category, will likely find them to be onerous.”

He added: “We believe this will thwart new product innovation from many small companies and favor the large tobacco companies.”

The rule extends the FDA’s authority over any newly regulated product, including e-cigarettes, not on the market before Feb. 15, 2007. The new regulations will likely take time to be implemented, as the FDA expects that manufacturers will sell their products for up to two years before they submit their product for FDA review. It will take another year for the FDA to review an application once it’s submitted.

Lavery said he expects Altria Group to challenge the ban on the company’s use of the term “mild” on cigar products, including its Black & Mild brand cigars, which would become regulated after 90 days under the new regulations. Manufacturing cigars with the term would be banned after a one-year transition period. Still, cigars are less than 1 percent of Altria’s volumes, Lavery pointed out.

A spokesman for Altria said the company is still reviewing the FDA’s regulations.

“We are concerned that FDA did not update the predicate date. FDA acknowledges that e-vapor products are ‘likely less hazardous’ for individuals compared to continued use of traditional cigarettes,” the spokesman said. “We continue to support legislation in Congress which would change the predicate date and also address other important issues such as setting battery standards and requiring that all e-vapor products be sold in a non-self-service fashion (with adult-only facility exception).”

The Smoke-Free Alternatives Trade Association, the trade group for the vaping industry, said the FDA’s actions would ban 99 percent of all vapor products on the market as a result of the Feb. 2007 predicate date.

“Today’s [Thursday’s] final rule pulls the rug out from the nine million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses,” the trade association said. “These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers. It also limits access to the 40 million adult smokers in the U.S. yet to make the switch to vaping and cripples a multi-billion dollar job-creating industry, the majority of which are made of small businesses.”

The trade group said the California law would negatively impact 1,400 vaping retail locations that are small businesses, “plus hundreds of manufacturers, distributors and related businesses that contribute to the state’s economy, generating taxes and thousands of jobs.”

“California took a step backwards today by reclassifying vapor products as tobacco,” the trade association said in a statement. “Stigmatizing vapor products, which contain no tobacco and treating them the same as combustible tobacco while actively seeking to economically penalize smokers attempting to switch is counterproductive to public health. We … will continue to work with the legislature, and voters, to educate them on what science says should be embraced as a far less harmful alternative to combustible cigarettes.”

Copyright © 2016, ABC Radio. All rights reserved.

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Paralyzed Pup Left on Shelter Doorstep with Heartbreaking Note

Humane Society of Tampa Bay(TAMPA BAY, Fla.) — One paralyzed pup is still smiling, despite being abandoned on the doorstep of a Florida shelter.

“Even though she’s had some very severe trauma to her spine, she’s as sweet as can be,” said Sherry Silk, CEO of the Humane Society of Tampa Bay, a no-kill shelter in Tampa, Florida. “… She’s bright, alert and she’ll give you little kisses.”

Silk told ABC News that on Monday morning, the shelter’s maintenance worker discovered an animal crate on the property.

Inside was Genie, an estimated 2-and-a-half-year-old Cocker Spaniel mix, and attached to her cage was a note from the dog’s previous owner.

It read: “Please help my Genie. Genie (her name) is paralyzed from I believe her hips to her hind legs. I tried to manage her pain with medication from her vet but they only ease her pain and she needs surgery. I cannot afford so I ask that the Animal Health Center heal her and find her a loving forever home. Thank you.”

Silk said the shelter’s veterinarian’s are unsure as to how Genie became paralyzed, but suspect she may have fallen or gotten hit by a car.

In addition to her disability, Genie also has bladder issues that vets are now trying to treat, Silk said.

And although the pup was left behind, Silk said the Humane Society feels no ill will toward Genie’s past owners.

“I know that had to be a hard decision to leave her in the middle of the night,” she said. “We’re doing our best to treat her now and believe with a combination of these medicines, that there will be enough improvements. There are are people that worry about handicapped animals, so I think we’ll be able to find her a home.”

Silk said the Humane Society of Tampa Bay has been asking for donations to get Genie a set of wheels.

Copyright © 2016, ABC Radio. All rights reserved.

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FDA Issues New Regulations for E-Cigarettes

iStock/Thinkstock(WASHINGTON) — E-cigarettes will face new regulations by the U.S. Food and Drug Administration, including requirements that affect manufacturing, ingredient labeling and not selling the product to those under the age of 18, the agency announced Thursday.

The FDA announced a plan to regulate e-cigarettes two years ago, but these are the first concrete regulations issued. The new rules affect not only e-cigarettes but more traditional tobacco products, including cigars, pipe tobacco and hookah tobacco.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction,” U.S. Department of Health and Human Services Secretary Sylvia Burwell said in a statement Thursday.

“Today’s announcement is an important step in the fight for a tobacco-free generation — it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions,” Burwell said.

Federal officials framed the new regulations as a way to take on the rapidly increasing rates of e-cigarette usage among teens. The new regulations will affect the selling, marketing and manufacturing of e-cigarettes and other tobacco products.

Newly announced prohibitions on selling e-cigarettes, hookah tobacco and cigars to people under 18 or giving free samples will start to be enforced within 90 days, according to the FDA.

Mitch Zeller, director of the Center for Tobacco Products, a part of the FDA, likened the current e-cigarette marketplace to “the wild, wild west,” pointing out that there have been reports of e-cigarettes exploding in recent months, causing burns on teens.

“Today is a first step, a foundational step, to bring all these previously unregulated products into the world of being regulated,” Zeller said during a news conference Thursday.

Health officials have been concerned that teens and other young adults may view e-cigarettes as an alternative to cigarettes with a rising number of teens using e-cigarettes. A recent survey found current e-cigarette use among high school students has risen sharply, from 1.5 percent in 2011 to 16 percent in 2015, according to the FDA and the U.S. Centers for Disease Control and Prevention.

An estimated three million middle and high school students were current e-cigarette users in 2015, according to the FDA. Data also showed high school boys smoked cigars at about the same rate as cigarettes.

To ensure compliance with new regulations, manufacturers of e-cigarettes will have to present their products to the FDA to meet public health standards. The new regulations include new requirements to report ingredients and any potentially harmful aspect of the product. Health warnings will be required on e-cigarette packages and ads and e-cigarette makers must register the places where their products are manufactured.

The new regulations will likely take time to be implemented, as the FDA expects that manufacturers will sell their products for up to two years before they submit their product for FDA review. It will take another year for the FDA to review the product the application.

While most of the regulations will not be implemented for years, prohibiting tobacco sales to those under 18 will start in 90 days. Burwell explained that currently “the absence of federal restriction means enforcement is uneven and sometimes non-existent” in preventing teens from buying e-cigarettes and other tobacco products.

Burwell called the regulations “common sense” actions to protect children from tobacco products.

“As a nation we have agreed for many years that nicotine does not belong in the hands of children,” Burwell said during Thursday’s new conference. “Progress has been made but the context has changed, we owe it to ourselves to do better.”

Zeller said his group is working with state officials on plans to enforce the ban on sales to those under 18 and that they will “hit the ground running.”

While regulations addressed many concerns of health officials, the FDA has not banned flavors in e-cigarettes. Flavored cigarettes were been banned in 2009 over concerns they may lead younger teens to smart smoking. Zeller said his group is monitoring how flavors affected users.

“As a physician, I’ve seen first-hand the devastating health effects of tobacco use,” FDA Commissioner Robert M. Califf, said in a statement. “At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review.”

Some health groups applauded by the move by the FDA, though others said they were disappointed the FDA didn’t take further action.

The March of Dimes commended the FDA.

“E-cigarettes are clearly tobacco products, and they should be strictly regulated as such,” March of Dimes President Dr. Jennifer L. Howse said in a statement. “Lack of regulation has allowed these products to be marketed and sold without limits, including to pregnant women and youth.”

The American Society of Clinical Oncology called the regulations a “crucial step” in regulating tobacco products and understanding the risks and benefits of e-cigarettes.

“Most importantly, we are concerned that e-cigarettes may encourage nonsmokers, particularly children, to start smoking and develop a nicotine addiction. FDA regulation will minimize the potential negative consequences of e-cigarettes and other ENDS [electronic nicotine delivery systems] without undermining their potential to reduce harm as a smoking cessation tool,” the group said.

The American Academy of Pediatrics also welcomed the regulations but called on the FDA to do more.

“More work must be done now as e-cigarettes become more and more common in households and communities across the country,” the organization said in a statement Thursday. “FDA passed up critical opportunities in this rule by failing to prohibit the sale of tobacco products coming in flavors like cotton candy, gummy bear and grape or to prevent marketing tactics that target children. The Academy also looks forward to a law — the Child Nicotine Poisoning Prevention Act — taking effect this summer that will require child-resistant packaging on liquid nicotine containers.”

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CDC Launches New Campaign on World Hand Hygiene Day

iStock/Thinkstock(ATLANTA) — Just in time for World Hand Hygiene Day, the Centers for Disease Control and Prevention is launching a new campaign Thursday urging medical professionals and patients to prevent healthcare-related infections by keeping their hands clean.

According to the CDC, an estimated 75,000 patients with these types of infections die each year in the hospital.

“Patients depend on their medical team to help them get well, and the first step is making sure healthcare professionals aren’t exposing them to new infections,” CDC Director Tom Frieden said in a statement. “Clean hands really do count and in some cases can be a matter of life and death.”

Dr. Clifford McDonald, an epidemiologist, tells ABC News that hand hygiene is often overlooked in medical facilities.

“We know that right now, on average, healthcare providers clean their hands less than 50 percent of the times that we know they should be cleaning their hands,” he says.

As part of the new campaign, the CDC wants patients and their loved ones to speak up.

“We know that patients can feel hesitant to speak up, but they are important members of the health care team and should expect clean hands from providers,” Arjun Srinivasan, the CDC’s associate director for healthcare-associated infection prevention programs, said in a statement. “We know that healthcare providers want the best for their patients, so we want to remind them that the simple step of cleaning their hands protects their patients.”

McDonald says health officials are recommending doctors use alcohol-based solutions before and after seeing a patient.

“These are so effective and they work so rapidly. They allow a higher margin for error in terms of doing it right,” he explains.

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FDA to Start Regulating E-Cigarettes

iStock/Thinkstock(WASHINGTON) — E-cigarettes will face new regulations by the U.S. Food and Drug Administration, including requirements that affect manufacturing, ingredient labeling and not selling the product to those under the age of 18, the agency announced on Thursday.

The FDA announced a plan to regulate e-cigarettes two years ago, but these are the first concrete regulations issued. The new rules affect not only e-cigarettes but more traditional tobacco products, including cigars, pipe tobacco and hookah tobacco.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction,” U.S. Department of Health and Human Services Secretary Sylvia Burwell said in a statement Thursday.

“Today’s announcement is an important step in the fight for a tobacco-free generation — it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions,” Burwell said.

The various new regulations affect the selling, marketing and manufacturing of e-cigarettes and other tobacco products.

Newly announced prohibitions on selling e-cigarettes, hookah tobacco and cigars to people under 18 or giving free samples will start to be enforced within 90 days, according to the FDA.

Health officials have been concerned that teens and other young adults may view e-cigarettes as an alternative to cigarettes with a rising number of teens using e-cigarettes. A recent survey found current e-cigarette use among high school students has risen sharply, from 1.5 percent in 2011 to 16 percent in 2015, according to the FDA and the U.S. Centers for Disease Control and Prevention.

An estimated three million middle and high school students were current e-cigarette users in 2015, according to the FDA. Data also showed high school boys smoked cigars at about the same rate as cigarettes.

To ensure compliance with new regulations, manufacturers of e-cigarettes will have to present their products to the FDA to meet public health standards. The new regulations include new requirements to report ingredients and any potentially harmful aspect of the product. Health warnings will be required on e-cigarette packages and ads, and e-cigarette makers must register the places where their products are manufactured.

The new regulations will likely take time to be implemented, as the FDA expects that manufacturers will sell their products for up to two years before they submit their product for FDA review. It will take another year for the FDA to review the product the application.

“As a physician, I’ve seen first-hand the devastating health effects of tobacco use,” FDA Commissioner Robert M. Califf said in a statement. “At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review.”

Copyright © 2016, ABC Radio. All rights reserved.

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Your Body: Colon Cancer in Young People

iStock/ThinkstockBy DR. JENNIFER ASHTON, ABC News Senior Medical Contributor

Colorectal cancer is not usually considered a disease of younger people, but that’s changing. Over the past 20 years, colon cancer rates have increased significantly between the age of 20 and 50.

Quite often, younger people ignore the symptoms, like rectal bleeding, hemorrhoids or worse. Other times, a doctor may dismiss the symptoms, saying, “These people are just too young to have colon cancer.”

While the cause of colon cancer remains unknown, doctors are taking a second look at how they diagnose younger patients.

Here’s my prescription: Remember that most people who have rectal bleeding don’t have cancer. Other symptoms include a change in bowel habits that last more than a few days or abdominal cramping.

The best prevention for colon cancer is not smoking, being physically active and eating a diet rich in vegetables and fruits.

Copyright © 2016, ABC Radio. All rights reserved.

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California Becomes Second State to Increase Smoking Age to 21

merznatalia/iStock/Thinkstock(LOS ANGELES) — California Governor Jerry Brown signed a series of bills into law on Wednesday expanding restrictions on smoking cigarettes and electronic cigarettes.

The most notable of the bills will raise the minimum smoking age in the state of California to 21 from 18. That change makes California the second state in the country to increase the minimum age to purchase tobacco products to 21, behind Hawaii. Brown also signed bills that would restrict use of electronic cigarettes in public and expand non-smoking areas at public schools.

The Los Angeles Times quotes Democratic State Senator Ed Hernandez, who authored the bill, as calling the approval “a signal that California presents a united front against Big Tobacco. Together, we stand to disrupt the chain of adolescent addiction.”

The bills were approved earlier in the year, and will become effective on June 9.

The National Survey on Drug Use and Health found that about 90 percent of tobacco users start before the age of 21.

The bill does exempt active military personnel under the age of 21 from the age increase.

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Reported Breakthrough in Growing Embryos in Vitro Could Raise Ethical Issues for Research

Medic Image/Getty(NEW YORK) — Scientists have reported they have grown human embryos in vitro for 12 to 13 days, significantly longer than the previous record of nine days.

If scientists are able to conduct experiments on embryos past 14 days, they may be able to “study all aspects of early human development with unprecedented precision,” according to commentators on the two breakthrough studies published Wednesday in Nature and Nature Cell Biology.

Two groups of researchers were able to get embryos to grow for 12 days and 13 days, respectively. Both groups used similar cutting-edge technology in which chemicals and a special medium mimicked a human womb so that the embryos would continue to develop, researchers said.

Part of technology involved creating a method that allowed the embryo to attach in a manner similar to that way it would in the womb. The breakthrough technology also raises ethical questions that were highlighted in an accompanying commentary.

Many countries currently restrict experiments on embryos to the first 14 days. Additionally, the International Society for Stem Cell Research has issued guidelines advising researchers across the globe to stick with this 14-day window. The authors of the commentary point out that experiments reaching close to the 14-day rule may mean medical officials will eventually revise this guideline.

“The 14-day rule was never intended to be a bright line denoting the onset of moral status in human embryos,” the authors wrote. “Rather, it is a public-policy tool designed to carve out a space for scientific inquiry and simultaneously show respect for the diverse views on human-embryo research.”

The 14-days limit was set due to how an embryo develops, according to the commentary. After approximately two weeks, the embryo starts to develop more distinct structures that will usually develop into a fetus and placenta. The authors note that the timeline was picked to be sensitive to the different views on when “a human embryo obtains sufficient moral status that research on it should be prohibited.”

Arthur Caplan, a bioethicist and head of the Division of Medical Ethics at New York University Langone Medical Center, said the breakthroughs means the medical community will have to re-evaluate what is ethical when it comes to experimentation on embryos.

“What is that entity?” asked Caplan, who was not involved in these studies. “Many people believe that it is a full person from conception, but it will renew that debate.”

Caplan pointed out that medical officials will have to grapple with the fact that embryonic experimentation past 14 days could lead to important results that help many pregnancies in the future.

“How far can you go with embryo research and how far can you go with editing the genes of embryos to repair them?” Caplan told ABC News. “All of this is in play in the same time.”

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Girl Diagnosed With Rare Genetic Disorder Thanks to Reddit

Hero Images/Getty(NEW YORK) — Bo Bigelow and his wife wondered for year why their daughter was different. Bigelow’s daughter, Tess, was non-verbal, has gastronintestinal symptoms and seemed to have periodic seizures, but doctors were baffled about the cause.

Bigelow said he and his wife were desperate to understand Tess’ condition but that multiple genetic tests didn’t give a clear answer. Geneticists figured out that Tess had a mutation on her USP7 gene, but they didn’t know if that was at all related to her symptoms.

Bigelow said Tess’ doctors ran out of tests to run last year and recommended that he and his wife learn to accept their daughter’s condition without a concrete diagnosis. As a last resort, the family put Tess’ story on different forms of social media in the hopes of contacting another family going through a similar ordeal.

“I put it out on Facebook on Sunday morning and my wife and thought it would be pretty long process of posting and re-posting,” Bigelow said. “By that same evening, I was on the phone with Dr. Mike Fountain at Baylor College.”

In just 24 hours, social media was able to do what multiple doctors in various states could not, they found an answer for Tess’ symptoms. Fountain, a researcher at the Baylor College of Medicine in Houston, had been studying USP7 and had found just seven other people with that genetic mutation. A lab associate had seen Bigelow’s story and posted on Reddit.

“Someone who shared the lab with Fountain saw it and said, ‘Isn’t this the gene you work with?’ And he said, ‘Yes, it is,'” Bigelow told ABC News.

As a result of reaching out to these specialists, Bigelow said he and his family finally understand what is happening to Tess. The mutation means that the cells “can’t recycle proteins right,” which is needed as part of a normal bodily function, Bigelow said.

“You wind up with a neuro-developmental disorder,” Bigelow explained in an online blog. “You have intellectual disability and probably autism and seizures.”

Tess is now 6 years old but has the mental capacity of an 18-month-old, according to her father.

“She’s almost entirely nonverbal and lot of the time it’s guess work about what she’s thinking or feeling,” Bigelow said. “She’s not aware of her own body or own safety, she’ll reach for the hot pan on the stove, everything goes into her mouth. You can’t take the attention away from her for a second.”

Bigelow said working with researchers and knowing the reason for Tess’ symptoms have been an incredible relief, even though there is not yet a treatment to help her.

“They’ve been amazing so far. We really just are getting started with them,” Bigelow said. “We are hopeful about some sort of experimental treatment.”

Bigelow’s posting on social media also led a second family to reach out for help. Bigelow said their child also had a USP7 mutation, but instead of having to wait years to know what that meant, they were able to find out within hours.

“I have a feeling we’ll be talking more,” Bigelow said.

The effects of the genetic mutation are still unclear, but the family has been able to make small changes that help Tess with vision and skin problems, Bigelow said, noting that in recent years after her diet was changed she’s appeared to be more outgoing and social.

“She is really sweet girl. She’s very affectionate and very social now and really lovey,” Bigelow said. “In her kindergarten she just loves being around her classmates and she’s a little social butterfly.”

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Wolbachia Bacteria Could Help Stop Mosquitoes Spreading Zika Virus, Study Finds

iStock/Thinkstock(NEW YORK) — In the fight against the spreading Zika virus, scientists have uncovered an unlikely ally in the form of a bacteria called “Wolbachia.”

The Aedes aegypti mosquito, the more abundant of the two species known to spread the Zika virus, are less able to spread the virus if they are exposed to the bacteria, according to a study published today in the medical journal Cell Host & Microbe.

The bacteria is already being used on the same mosquitoes as a way to curb the spread of the dengue virus, which, like Zika, is a flavivirus.

Mosquitoes containing this bacterium did not become infected with the Zika virus when given saliva from other infected mosquitoes, researchers from the Rene Rachou-Fiocruz Research Center in Brazil discovered. When they did the same test in mosquitoes without the Wolbachia bacteria, approximately 85 percent of mosquitoes became infected with the Zika virus.

“The results presented here indicate that [Wolbachia-infected mosquitoes] represent a realistic and effective option to combat the ZIKV [Zika virus] burden in Brazil and potentially in other countries and should be considered as an integral part of future control efforts,” the authors concluded.

Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center, told ABC News that experimental treatments like this one may be key to stopping the Aedes aeygpti mosquito, which is notoriously hard to eradicate.

“These are clever ways to try to interrupt the transmission of the virus in an ecologically sensitive way, while we’re waiting to get a vaccine developed,” Schaffner said.

The Aedes aegypti mosquito can live indoors and bite during the day, Schaffner noted, making it extremely difficult to kill with normal outdoor spraying. Spraying may need to be used with other experimental treatments, including used genetically modified mosquitoes, to cut down on the population, he said.

“If you look realistically at what we have currently available in all of our local municipal public health jurisdictions … funding for mosquito abatement, it varies enormously from municipality to municipality,” Schaffner said. “It’s focused on nuisance mosquitoes and not disease-causing mosquitoes and Aedes [aegypti] is much more tenacious,” than other mosquito species.

More information is needed about the feasibility of infecting the mosquitoes with the bacteria, since the cost and technology needed may make it impractical outside of a lab setting, Schaffner said.

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