FDA Approves First in New Class of Drugs for Advanced Ovarian Cancer
Agency also gives OK to genetic test used to identify eligible patients
FRIDAY, Dec. 19, 2014 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new drug to treat advanced ovarian cancer, along with a test to identify patients eligible to receive the drug.
Lynparza (olaparib) belongs to a new class of drugs called poly ADP-ribose polymerase (PARP) inhibitors. The drug is for women who have already received extensive treatment for advanced ovarian cancer associated with defective BRCA genes, according to an FDA news release issued Friday.
"Today's approval constitutes the first of a new class of drugs for treating ovarian cancer," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in the news release.
"Lynparza is approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment," he said.
Approval of the AstraZeneca drug was based on a clinical trial of almost 140 women with BRCA mutation-associated ovarian cancer. Thirty-four percent of the patients on the drug had partial shrinkage or complete disappearance of their tumors for an average of eight months, the FDA reported.
Nausea, fatigue, vomiting, diarrhea, headache, decreased appetite, joint and muscle pain, and cold-like symptoms were common side effects of the drug. More serious side effects included lung inflammation; the bone marrow cancer acute myeloid leukemia; and myelodysplastic syndrome, a condition where the bone marrow is unable to produce enough functioning blood cells, the FDA said.
Women must undergo a genetic test to confirm BRCA gene mutations before they can be treated with Lynparza. The test to confirm those genes was approved by the FDA in conjunction with the drug.
BRCA genes play a role in repairing damaged DNA. Normally, they work to suppress tumor growth. Women with mutations that cause defective BRCA genes have an increased risk for ovarian and breast cancer. It's believed that 10 to 15 percent of all ovarian cancer is associated with these mutations, the FDA said.
In 2014, nearly 22,000 American women will be diagnosed with ovarian cancer and more than 14,000 will die from the disease, according to the U.S. National Cancer Institute.
The American Cancer Society has more about ovarian cancer (http://www.cancer.org/cancer/ovariancancer/detailedguide/ovarian-cancer-what-is-ovarian-cancer ).
SOURCE: U.S. Food and Drug Administration, news release, Dec. 19, 2014
Vaccine for Deer Against 'Mad Cow'-Like Illness Shows Promise
Might be useful for livestock and even people, researchers say
SUNDAY, Dec. 21, 2014 (HealthDay News) -- A new vaccine created to fight an illness similar to "mad cow disease" in deer might also protect livestock and even humans from similar brain infections, researchers report.
The vaccine appears to help prevent deer from becoming infected by the incurable brain disorder known as chronic wasting disease, according to the report in the Dec. 21 online edition of the journal Vaccine. Chronic wasting disease is caused by mysterious infectious particles known as prions that go rogue.
Prion infections are also thought to cause horrific human diseases such as Creutzfeldt-Jakob disease (including the strain behind mad cow disease), kuru (a condition that affects cannibals who eat human brain), and fatal familial insomnia (an inherited condition that leads to increasing sleeplessness and death), the researchers said.
"Now that we have found that preventing prion infection is possible in animals, it's likely feasible in humans as well," senior study investigator and neurologist Dr. Thomas Wisniewski, of NYU Langone Medical Center in New York City, said in an NYU news release.
Chronic wasting disease is common in North America's captive deer and in the wild. The disease also affects elk, caribou and moose, and scientists fear it could spread to livestock, especially cattle.
If further research confirms the vaccine's effectiveness, the study authors hope they can vaccinate a small number of animals, maybe 10 percent, and stop overall transmission of the disease, according to the news release.
For this study, the researchers gave five deer the vaccine, while another six received an inactive placebo. All of the deer were exposed to prion-infected brain tissue.
Monitoring over two years showed that all of the deer given the placebo developed chronic wasting disease. Four deer given the real vaccine took significantly longer to develop infection -- and the fifth one is infection-free, the researchers said.
"Although our anti-prion vaccine experiments have so far been successful on mice and deer, we predict that the method and concept could become a widespread technique for not only preventing, but potentially treating many prion diseases," said lead study investigator Fernando Goni, an associate professor at NYU Langone, in the news release.
For more about chronic wasting disease in deer, see the Chronic Wasting Disease Alliance (http://www.cwd-info.org/index.php/fuseaction/about.main ).
SOURCE: NYU Langone Medical Center, news release, Dec. 21, 2014
Holiday Trimmings Can Trigger Allergies
Some tips to avoid bad reactions to the seasonal good times
SATURDAY, Dec. 20, 2014 (HealthDay News) -- The holidays can be anything but joyous for people with allergies when they contend with fresh trees, scented candles and other allergy triggers.
"The dust from the boxes and on the decorations that have been packed away in dank basements or dusty attics is triggering reactions in my allergy and asthma patients," Dr. Rachna Shah, an affiliate faculty member at Loyola University Chicago Stritch School of Medicine, said in Loyola news release.
Shah, who is also an allergist at Gottlieb Memorial Hospital in Melrose Park, Ill., offered some tips to help people with allergies breathe easier during the holidays.
Clean your Christmas tree, whether it's real or artificial. "A tree that is moldy increases the spore counts in the home exponentially after just a few days, triggering reactions and illness," Shah said. "Some have found relief by spraying down the tree with water to remove mold and then limiting the amount of time the tree is indoors to 12 days or less."
If you decide on a live tree, you need to know that no variety is less allergenic than others. Also, stagnant water in the tree holder collects mold, which can trigger allergies.
"Artificial is the best if you have allergies," Shah said.
Store decorations in sealed plastic tubs and clean them occasionally during the year and before you use them.
If you or a family member has food allergies, bring your own treats to parties. "Those with egg, nut or dairy allergies especially can play it safe and enjoy the parties if they know what they are eating and drinking," Shah said. "Communicating in advance with the host can help avoid illness."
Do not use scented candles or home fragrance oils, keep your home free of real poinsettias and fresh floral arrangements, and control the humidity levels in your home in order to prevent the growth of mold, Shah advised.
And take time to relax. "Anxiety has been shown to increase asthma symptoms," Shah said. "Use relaxation methods such as deep breathing, meditation or yoga to maintain control during the holiday hustle-bustle."
The U.S. National Library of Medicine has more about allergies (http://www.nlm.nih.gov/medlineplus/allergy.html ).
SOURCE: Loyola University, news release, December 2014
CDC Warns of Listeria Danger From Caramel Apples
Outbreak has sickened 28 people in 10 states; 4 have died and 26 have been hospitalized, agency says
FRIDAY, Dec. 19, 2014 (HealthDay News) -- U.S. and state health officials are investigating a listeria outbreak linked to caramel apples that has killed at least four people and sickened 28 others in 10 states.
Consumers should not eat any commercially produced, prepackaged caramel apples until more information becomes available, the U.S. Centers for Disease Control and Prevention said in a news release.
As of Dec. 18, a total of 28 people had been infected with the outbreak strains of the bacteria Listeria monocytogenes. Of the 26 people who have been hospitalized, five have died. Listeria infections contributed to at least four of those deaths, the agency said.
Nine illnesses occurred in pregnant women or newborn infants, and there have been three cases of invasive illness (meningitis) among otherwise healthy children aged 5 to 15, the CDC said.
Symptoms of listeria infection include fever, chills, headache, upset stomach and vomiting. Antibiotics are typically used to treat the infection.
Of the 18 ill people interviewed so far, 15 said they ate commercially produced, prepackaged caramel apples before becoming sick. To date, no illnesses have been linked to apples that are not caramel-coated and prepackaged, or to caramel candy.
Although caramel apples are usually sold in the fall, the CDC said they may still be for sale in stores or may be in consumers' homes.
Investigators are trying to identify specific brands of caramel apples that may be linked to the outbreak, and to pinpoint the source of contamination, the CDC said.
Dr. Ambreen Khalil is an infectious disease specialist at Staten Island University Hospital in New York City. She explained that listeria is a "food-borne illness that can [show up] in different forms, including bloodstream infections, infections of the central nervous system such as meningitis, or brain abscesses, gastroenteritis or endocarditis," which can affect the heart.
Listeria poses particular problems for people with weakened immune systems as well as pregnant women and the elderly, Khalil said.
Dr. Leonard Krilov, chief of pediatric infectious diseases at Winthrop-University Hospital in Mineola, N.Y., said recommended guidelines to prevent listeria infection include rinsing raw produce or scrubbing firm-skinned produce -- such as melons and cucumbers -- and then drying them well.
The U.S. National Library of Medicine has more about listeria infections (http://www.nlm.nih.gov/medlineplus/listeriainfections.html ).
SOURCES: U.S. Centers for Disease Control and Prevention, news release, Dec. 19, 2014; Ambreen Khalil, M.D., infectious disease specialist, Staten Island University Hospital, New York City; Leonard Krilov, M.D., chief of pediatric infectious diseases, Winthrop-University Hospital, Mineola, N.Y.
Older Cars a Bad Choice for Younger Drivers
Study found nearly half of teen crashes involved cars more than a decade old
FRIDAY, Dec. 19, 2014 (HealthDay News) -- New research warns parents that buying an older car for their teens may put their young lives at risk.
Nearly half of teen drivers killed in the United States between 2008 and 2012 were driving cars that were at least 11 years old and often lacked important safety features that are available on newer cars, the study found.
Eighty-two percent of teen drivers killed in crashes were in cars at least six years old, 34 percent were in cars six to 10 years old, 31 percent were in cars 11 to 15 years old, and 17 percent were in cars at least 16 years old.
Teen drivers killed in crashes were nearly twice as likely as middle-aged drivers to be in a car that was 11 to 15 years old, 20 percent vs. 12 percent, according to the study published online Dec. 18 in the journal Injury Prevention.
The findings are from an analysis of more than 2,000 teen (ages 15-17) driver deaths and almost 19,000 middle-aged (ages 35-50) driver deaths.
Only about one in 10 of the vehicles driven by fatally injured teens had electronic stability control. This feature is particularly useful when a driver loses control, a relatively common problem among newly licensed young drivers, the researchers noted. They said electronic stability control can reduce the risk of death in single-vehicle crashes by about half and by about 20 percent in multivehicle crashes.
Only 36 percent of vehicles driven by teen and middle-aged drivers had optional or standard air bags, but those driven by adults were slightly more likely to have air bags as standard equipment.
The study authors also looked at the types of vehicles in fatal crashes and found that 29 percent were in a mini or small car, 35 percent were in a midsize or large car, 17 percent were in pickups and 17 percent were in SUVs.
Teens who died in crashes were more likely than middle-aged drivers to be in a mini or small car (29 percent vs. 20 percent) or a midsize car (23 percent vs. 16 percent), and less likely to be in a large pickup (10 percent vs. 16 percent).
Because teens are more likely to get into crashes than older drivers, it's important for parents to consider safety as well as cost when choosing a vehicle for their children, the researchers said.
Newer vehicles are "more likely to have better crash test ratings and important safety features such as [electronic stability control] and side air bags," they noted, adding: "Parents may benefit from consumer information about vehicle choices that are both safe and economical."
The U.S. Centers for Disease Control and Prevention has more about teen drivers (http://www.cdc.gov/Motorvehiclesafety/Teen_Drivers/ ).
SOURCE: Injury Prevention, news release, Dec. 18, 2014
Preschoolers Need Eye Screening, Experts Say
Testing recommended annually from age 3 to 6
FRIDAY, Dec. 19, 2014 (HealthDay News) -- All children should have their eyesight checked between the ages of 3 and 6, preferably every year, eye experts say.
The new vision-screening guidelines for preschool-aged children are from an expert panel of the U.S. National Center for Children's Vision Health.
The panel said that children in this age group require screening for eye problems, particularly vision issues that require correction with glasses, such as amblyopia ("lazy eye") and strabismus (a disorder of eye alignment).
Early detection and treatment of vision problems is important in terms of a child's development and readiness to school, according to the authors of the recommendations in the January issue of the journal Optometry and Vision Science.
The two "best practice" screening tests identified in the guidelines are visual acuity testing with eye charts and instrument-based testing using equipment called an autorefractor.
The panel also outlined how the screening tests should be performed and how screeners should be trained and certified.
"Unfortunately, many children receive neither appropriate screening to help identify those who need immediate eye attention, nor a comprehensive examination by an eye care professional, prior to beginning school," Anthony Adams, journal editor-in-chief, said in a journal news release.
"These National Expert Panel reports are an important starting point for identifying vision health screening procedures and tests and definitions of expected performance measures to be tracked across the country," Adams said. The goal, he said, is to ensure that children with problems identified on screening tests receive appropriate, comprehensive eye examinations and follow-up care.
The American Academy of Pediatrics outlines the warning signs of vision problems in children (http://www.healthychildren.org/English/health-issues/conditions/eyes/Pages/Warning-Signs-of-Vison-Problems-in-Children.aspx ).
SOURCE: Optometry and Vision Science, news release, Dec. 12, 2014
Cocaine, Amphetamines May Up Injection Drug Users' Suicide Risk
These substances doubled the likelihood of an attempt, study says
FRIDAY, Dec. 19, 2014 (HealthDay News) -- Injectable drug users who also use cocaine and amphetamines have nearly double the suicide attempt rate of other substance users, a new study finds.
"We know that substance use is associated with the risk of suicide attempt and completed suicide," Didier Jutras-Aswad, a psychiatry professor at the University of Montreal, said in a university news release. "However, there are many different profiles of drug users. We wanted to know who among substance users were actually more likely to attempt suicide."
The researchers studied 1,200 adults who had injected drugs within the previous six months. In surveys, researchers asked them questions about drug use and suicide attempts.
At the start of the study, 6 percent of participants said they'd tried to commit suicide within the past six months, a much higher rate than in the general population.
Participants were then questioned twice a year for an average of four follow-up visits. During this follow-up, 143 participants reported at least one attempted suicide. Chronic and occasional use of stimulants such as cocaine and amphetamines was associated with nearly two times greater odds of reporting an attempt than the use of other drugs, the researchers found.
The researchers suspect that cocaine and amphetamine users are more vulnerable to suicidal urges because they're more impulsive and moodier than people who use narcotic painkillers, for example. Also, they said, there are few cocaine addiction programs to help them stop using the drug.
"Our study addresses a number of important issues that could change practice," Jutras-Aswad said. "While it confirms that drug use itself represents a significant risk for suicidal behavior, it identifies cocaine and amphetamine users as a higher-risk population. We therefore need to develop more effective intervention and prevention programs tailored to this target population."
The study was published recently in the journal Drug and Alcohol Dependence.
For more about drug use (http://www.nlm.nih.gov/medlineplus/drugabuse.html ), try the U.S. National Library of Medicine.
SOURCE: University of Montreal, news release, Dec. 16, 2014
Could Bacteria Play a Role in Colon Cancer?
Bacterial 'bunches' were prevalent on colon polyps, cancers, study found
FRIDAY, Dec. 19, 2014 (HealthDay News) -- Dense bunches of bacteria called biofilms can be found on most colon polyps and cancers, a new study finds.
The researchers said these biofilms were especially prevalent on the right side of the colon.
The presence of these biofilms may represent an increased likelihood of colon cancer and could offer a new way to predict a person's risk for the disease, the researchers said.
Like tooth plaque and slime on pond stones, these biofilms may coat the mucus layer of cells lining the colon, according to background information from the study. There, the biofilms may cause inflammation and some noncancerous bowel diseases, said Dr. Cynthia Sears, professor of medicine and oncology at the Johns Hopkins University School of Medicine and Bloomberg School of Public Health.
The researchers examined healthy and cancerous tissue collected during biopsies on almost 120 people. Biofilms were present on 89 percent of tumors removed from the right colon, according to the researchers.
Biofilms were found on only 12 percent of tumors removed from the left side of the colon. The reasons for the difference between the right and left side of the colon are unknown, the researchers said.
The risk of developing colon cancer may be five times higher in people with biofilms on the right side of the colon, compared to those with no biofilms, said the authors of the study.
"What was so striking was that these biofilm-positive samples cluster so dramatically in the right colon. In fact, it's virtually a universal feature of tumors that appear in that section of the colon, although we don't understand why," Sears said in a Hopkins news release.
It may be possible to develop a noninvasive test to detect these biofilms and predict a person's risk of developing colon cancer. Most of these cancers develop over five to 10 years "and it's a disease that's curable if you diagnose it early," Sears said.
Colonoscopies are currently the "gold standard" in detecting colon cancer. But only about 60 percent of Americans get them, according to the researchers. And colonoscopies often aren't available in resource-poor countries, they noted.
The study was published online recently in the journal Proceedings of the National Academy of Sciences.
The American Cancer Society has more about colorectal cancer (http://www.cancer.org/cancer/colonandrectumcancer/overviewguide/colorectal-cancer-overview-what-is-colorectal-cancer ).
SOURCE: Johns Hopkins Medicine, news release, Dec. 16, 2014
Crohn's, Colitis May Have Genetic Underpinnings, Study Finds
Scientists find evidence that genes influence the mix and make-up of gut bacteria
FRIDAY, Dec. 19, 2014 (HealthDay News) -- The intestinal bacteria that cause inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, may be inherited, researchers report.
The findings, published recently in the journal Genome Medicine, could help in efforts to prevent the disease and treat the 1.6 million Americans with Crohn's or colitis, the study authors added.
"The intestinal bacteria, or 'gut microbiome,' you develop at a very young age can have a big impact on your health for the rest of your life," lead author Dan Knights, an assistant professor in the department of computer science and engineering and the Biotechnology Institute at the University of Minnesota, said in a journal news release.
"We have found groups of genes that may play a role in shaping the development of imbalanced gut microbes," he explained.
The study of 474 adults with inflammatory bowel disease who live in the United States, Canada and the Netherlands found a link between the participants' DNA and their gut bacteria DNA. The Crohn's and colitis patients also had less variety of gut bacteria and more opportunistic bacteria than the general population.
The findings are an important step in creating new drugs for the treatment of Crohn's and colitis, the researchers said.
The investigators also found that antibiotics can worsen the imbalances in intestinal bacteria associated with inflammatory bowel disease.
"In many cases, we're still learning how these bacteria influence our risk of disease, but understanding the human genetics component is a necessary step in unraveling the mystery," Knights said.
Previous research has identified associations between gut bacteria and increased risks for health problems such as diabetes, autism, heart disease and some types of cancer, the researchers said.
The U.S. Centers for Disease Control and Prevention has more about inflammatory bowel disease (http://www.cdc.gov/ibd/ ).
SOURCE: Genome Medicine, news release, Dec. 16, 2014
E-Cigarettes Less Addictive Than Regular Cigarettes, Study Finds
Users report fewer cravings, less irritability
FRIDAY, Dec. 19, 2014 (HealthDay News) -- Former tobacco smokers find e-cigarettes less addictive than traditional cigarettes, new research finds.
Even though they "smoke" e-cigarettes as often as they did regular cigarettes, thousands of ex-smokers said they have fewer cravings and are less likely to feel impulsive and irritable over their need to smoke, researchers reported.
"The pattern was really very clear. The score was significantly less for e-cig use than for tobacco use," said lead researcher Jonathan Foulds, a professor of public health sciences and psychiatry at Penn State College of Medicine. "E-cig users feel less addicted."
E-cigarettes have become more popular during the past five years, the researchers said in background information. These battery-powered devices deliver nicotine and flavorings through inhaled vapor, and some people say they help smokers give up traditional cigarettes. While they contain far fewer cancer-causing and toxic substances than cigarettes, their long-term health effects are unknown.
For this study, recently published in Nicotine & Tobacco Research, the researchers used an online survey to assess more than 3,600 e-cig users' previous dependence on cigarettes and their current dependence on e-cigarettes.
The ex-smokers, all of whom now use e-cigarettes, reported their smoking is about the same. They have about 24 sessions a day with e-cigarettes, and used to smoke about 24 cigarettes daily.
However, their dependence on e-cigarettes is much different:
They are more likely to wait longer for their first smoke of the day, 45 minutes on average compared to 27 minutes when they used cigarettes.
Two out of five would wake in the middle of the night to smoke a cigarette, but only about 7 percent continued to do so with e-cigarettes.
About one-third had strong cravings to use their e-cigarettes, compared with more than nine out of 10 when they smoked cigarettes.
About one-quarter reported being irritable or nervous when they can't use e-cigarettes, versus more than 90 percent who recalled feeling that way as cigarette smokers.
There are a couple of reasons why e-cigarettes might create less addiction to nicotine, Foulds said.
First, e-cigarettes typically are worse at delivering nicotine than tobacco cigarettes. "Blood nicotine levels get a much larger boost with smoking than with e-cigarettes," he said.
How people use e-cigarettes also might help explain the difference.
Because people don't have to light an e-cigarette, they are under less pressure to smoke in concentrated bouts, Foulds said.
"When you smoke cigarettes, you smoke it in one go. You go outside from your workplace and you take 10 puffs, you smoke it until it's three-quarters done and then you throw it away," he said. "With e-cigs, they take two or three puffs, and then wait 10 or 15 minutes and have another two or three puffs. It's kind of like they're grazing on it, rather than binging on it."
Health advocates said they found the study interesting, but remain reluctant to endorse e-cigarette use. The devices are not regulated by the U.S. Food and Drug Administration, although the agency has announced its intention to extend its tobacco authority to cover e-cigarettes.
"Unregulated products, particularly those that are marketed as intending to help smokers quit, are very troubling," said Erika Sward, assistant vice president of national advocacy for the American Lung Association. "Where we have this unregulated situation, we don't know the ultimate health effects of using these products."
Manufacturers of e-cigarettes are producing more powerful devices that deliver higher nicotine concentrations, Sward said.
Such innovations could increase the addictive powers of e-cigarettes, and concerns exist that e-cigarettes maintain nicotine dependence for people who might otherwise have quit smoking altogether, she said. Experts also worry that kids who use e-cigarettes might find them a "gateway drug" that leads to tobacco use.
The study authors noted that dependence might vary by liquid nicotine concentration, product characteristics and could increase with time.
This study used a new addiction measurement questionnaire that could "lead to improvements in cessation treatment for both traditional cigarette smokers as well as electronic cigarette users," said Patricia Folan, director of the Center for Tobacco Control at the North Shore-LIJ Health System in Great Neck, N.Y.
However, Folan added that in this study "there is some concern about comparing an individual's past recollection of their addiction to traditional cigarettes with their current addiction to electronic devices."
The researchers received funding from Penn State Social Science Research Institute and Cancer Institute, the U.S. National Institute on Drug Abuse of the National Institutes of Health and the FDA's Center for Tobacco Products.
For more on e-cigarettes, visit the U.S. Food and Drug Administration (http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm ).
SOURCES: Jonathan Foulds, Ph.D., professor, public health sciences and psychiatry, Penn State College of Medicine; Erika Sward, assistant vice president of national advocacy, American Lung Association; Patricia Folan, D.N.P., director, Center for Tobacco Control, North Shore-LIJ Health System, Great Neck, N.Y.; Oct. 19, 2014, Nicotine & Tobacco Research