FDA Renews Warning on HeartStart Defibrillator Failures
Owners of the recalled Philips automated external defibrillators advised to contact the company
WEDNESDAY, Dec. 4, 2013 (HealthDay News) -- Hundreds of thousands of automated external defibrillators (AEDs) made by Philips Healthcare might not deliver a needed shock to the heart in an emergency, the U.S. Food and Drug Administration said in an updated warning.
The devices were made and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart Home and HeartStart OnSite.
About 700,000 of the devices were recalled in September 2012 because of the potential for an electrical-component failure, which would prevent the device from delivering the shock needed to restore a normal heart rhythm.
AEDs, which are available in many public locations, are designed to automatically analyze the heart rhythm of people in cardiac arrest and deliver an appropriate shock to the heart. When they are working properly and used correctly, AEDs help save the lives of cardiac arrest victims.
Owners of the recalled Philips AEDs should contact the company immediately at 1-800-263-3342 and select option five for technical support, the FDA said. The agency said owners should keep their recalled AEDs in service until Philips replaces them or they obtain another working AED.
The Philips HeartStart AEDs have a self-testing feature that should automatically check the device to make sure it is functioning and ready for use. If the device detects a serious problem that could prevent it from delivering an electrical shock, it should emit a triple chirp sound and the "i-button" should start flashing, the FDA said in a news release.
In March 2013, the FDA proposed new approval rules meant to improve the reliability of AEDs.
The U.S. National Heart, Lung, and Blood Institute has more about automated external defibrillators (http://www.nhlbi.nih.gov/health/health-topics/topics/aed/ ).
SOURCE: U.S. Food and Drug Administration, news release, Dec. 3, 2013
Morphine, Blood Thinner Plavix a Bad Mix for Heart Attack Victims: Study
Painkiller appeared to slow, diminish anti-clotting effect of heart drug
WEDNESDAY, Dec. 4, 2013 (HealthDay News) -- Morphine appears to reduce the effectiveness of the commonly used blood-thinning drug Plavix, which could hamper emergency-room efforts to treat heart attack victims, Austrian researchers report.
The finding could create serious dilemmas in the ER, where doctors have to weigh a heart patient's intense pain against the need to break up and prevent blood clots, said Dr. Deepak Bhatt, executive director of interventional cardiovascular programs at Brigham and Women's Hospital Heart and Vascular Center, in Boston.
"If a patient is having crushing heart pain, you can't just tell them to tough it out, and morphine is the most commonly used medication in that situation," said Bhatt, who was not involved in the study. "Giving them morphine is the humane thing to do, but it could also create delays in care."
Doctors will have to be particularly careful if a heart attack patient needs to have a stent implanted, he said. Blood thinners are critical in preventing blood clots from forming around the stent.
"If that situation is unfolding, it requires a little bit of extra thought on the part of the physician whether they want to give that full slug of morphine or not," Bhatt said.
About half of the 600,000 stent procedures that take place in the United States each year occur as the result of a heart attack, angina or other acute coronary syndrome, he said.
The Austrian researchers focused on 24 healthy people who received either a dose of Plavix with an injection of morphine or a placebo drug.
Morphine delayed the ability of Plavix (clopidogrel) to thin a patient's blood by an average of two hours, the researchers said.
The painkiller also delayed the body's absorption of Plavix and decreased blood levels of the drug by about half. It further seemed to diminish the effectiveness of the medication in breaking up blood clots.
Although the study showed an association between morphine and diminished effectiveness of Plavix, however, it did not prove a cause-and-effect relationship.
"Co-administration of morphine and [Plavix] should likely be avoided, if possible," the researchers said.
Their findings were published online Dec. 4 in the Journal of the American College of Cardiology.
This potential drug interaction is not well known, and Bhatt said news of these findings needs to be distributed as soon as possible.
"The first step would be awareness," he said. "I don't think many doctors are going to ever think of this potential interaction."
Bhatt said he isn't concerned about heart attack victims who are taking Plavix prior to their cardiac episode, because the drug already will be built up in their bloodstream.
The people with the most potential for harm are those not taking Plavix who are in the middle of a heart attack and need both pain relief and an immediate high level of the blood thinner in their system, he said.
One option to get around this interaction is to get the patient into a catheterization lab as soon as possible to treat the source of the pain rather than using morphine to dull the pain, Bhatt said.
Doctors might also use other blood-thinning drugs, said Dr. Gregg Fonarow, a spokesman for the American Heart Association.
Although Plavix is a widely used therapy, many medications have been shown to interfere with its ability to act, he said.
"More potent antiplatelet agents -- prasugrel [Effient] and ticagrelor [Brilinta] -- are now available for treatment of patients with acute coronary syndromes and do not have the same type of drug interactions," said Fonarow, who is also a professor of cardiology at the University of California, Los Angeles.
Bhatt, however, said he is concerned that morphine might have the same effect on these other blood thinners.
"I think there's a reasonable chance the same phenomenon might occur with both those agents," he said. "We need further research."
For more on heart attacks, visit the U.S. National Heart, Lung, and Blood Institute (http://www.nhlbi.nih.gov/health/health-topics/topics/heartattack/ ).
SOURCES: Deepak Bhatt, M.D., executive director, interventional cardiovascular programs, Brigham and Women's Hospital Heart and Vascular Center, and professor, medicine, Harvard Medical School, Boston; Gregg Fonarow, M.D., director, Ahmanson-UCLA Cardiomyopathy Center, and co-chief, clinical cardiology, UCLA Division of Cardiology, Los Angeles; Dec. 4, 2013, Journal of the American College of Cardiology, online
AMA's RUC Committee to Work on Improving Transparency
New means to be used to survey physicians to better determine value of procedures
WEDNESDAY, Dec. 4, 2013 (HealthDay News) -- The 31-member Relative Value Scale Update Committee (RUC) of the American Medical Association will begin publishing minutes, dates and locations of meetings, and votes for individual current procedural codes, according to an article published Nov. 11 in Medical Economics.
Although RUC is an independent body, for the past 22 years the Centers for Medicare and Medicaid Services has used roughly 90 to 95 percent of RUC's recommendations to inform its annual fee schedule. RUC has been criticized for overvaluing certain procedures (like colonoscopies that are valued at 75 minutes but actually take 15 minutes), which some believe has led to disparities in reimbursements between specialists and primary care physicians.
In addition to the measures aimed at increasing transparency, RUC will also reformat the way it gathers information from physicians used to set values for services. Going forward, the committee will require more surveys for the most frequently performed procedures -- at least 50 surveys for procedures performed more than 100,000 times annually and at least 75 surveys for procedures performed more than one million times annually.
"Only time will tell whether these changes lead to a fair evaluation of all physician services, particularly primary care," said Glen Stream, M.D., immediate past board chair of the American Academy of Family Physicians, according to the Medical Economics article.
Full Article (http://medicaleconomics.modernmedicine.com/medical-economics/news/ruc-committee-takes-steps-toward-transparency )
Could Good Manners Help Spur Holiday Weight Gain?
People may choose less healthy foods to avoid offending someone heavier, study finds
MONDAY, Nov. 25, 2013 (HealthDay News) -- Politeness and consideration for fellow diners could play a role in holiday weight gain, a new study suggests.
When people are picking snacks and other foods for themselves and someone else, their choices are different when the other person is average-sized than when the person is overweight, the researchers found.
In an experiment, participants chose a snack of either wheat crackers or chocolate chip cookies for themselves and a woman they had just met. In some cases, the woman was her normal weight (wearing a size zero or two). At other times she wore a body suit that appeared to increase her weight by nearly 65 pounds (making her closer to a size 16).
Nearly 60 percent of the participants chose the same snack for themselves and the woman when she appeared overweight. But, this occurred just about 30 percent of the time when the woman was her normal size.
"What the results show is that people pick the same snack to avoid offending someone they perceive as overweight," study co-leader Gavan Fitzsimons, a marketing professor at the Duke University School of Business, said in a university news release.
"This means that people might pick unhealthier options for themselves and others during the holidays if they think not doing so could hurt someone's feelings," he said.
In additional experiments, participants told the researchers they thought it would be offensive to give an overweight person healthy food and then take unhealthy food for themselves, said study co-leader Peggy Liu, a marketing doctoral student. Similarly, the participants said it would be offensive to give an overweight person unhealthy food and then take healthy food for themselves.
"This suggests that if you are heading back to the buffet to cut a piece of pumpkin pie for your overweight uncle, you might also cut a larger piece than normal for yourself so you don't hurt his feelings," Liu said in the news release.
The study appears in the November issue of the journal Organizational Behavior and Human Decision Processes.
The U.S. Centers for Disease Control and Prevention outlines how to prevent weight gain (http://www.cdc.gov/healthyweight/prevention/index.html ).
SOURCE: Duke University, news release, Nov. 22, 2013
Deciphering the DNA of Alzheimer's Patients
First batch of complete genetic data on 410 people with the disease made available to scientists
WEDNESDAY, Dec. 4, 2013 (HealthDay News) -- Data that details every gene in the DNA of 410 people with Alzheimer's disease can now be studied by researchers, the U.S. National Institutes of Health announced this week.
This first batch of genetic data is now available from the Alzheimer's Disease Sequencing Project, launched in February 2012 as part of an intensified national effort to find ways to prevent and treat Alzheimer's disease.
Genome sequencing outlines the order of all 3 billion chemical letters in an individual's DNA, which is the entire set of genetic data every person carries in every cell.
"Providing raw DNA sequence data to a wide range of researchers is a powerful, crowd-sourced way to find genomic changes that put us at increased risk for this devastating disease," NIH Director Dr. Francis Collins said in an institute news release.
"The [genome project] is designed to identify genetic risks for late onset of Alzheimer's disease, but it could also discover versions of genes that protect us," Collins said. "These insights could lead to a new era in prevention and treatment."
As many as 5 million Americans aged 65 and older have Alzheimer's disease, and that number is expected to grow significantly as the baby boomer generation ages.
Genome sequencing is considered a key strategy for identifying new clues to the cause of Alzheimer's. The clues would come from differences in the order of DNA letters in Alzheimer's patients when compared to people without the disease, according to the NIH.
The National Alzheimer's Project Act, which became law in 2011, is meant to boost efforts to combat the disease. It calls for more research by both the public and private sectors, along with expanded access to clinical and long-term care. One of the first actions taken by the NIH under the act was funding a series of studies, including this genome-sequencing effort.
The U.S. National Institute on Aging has more about Alzheimer's disease (http://www.nia.nih.gov/alzheimers/topics/alzheimers-basics ).
SOURCE: U.S. National Institutes of Health, news release, Dec. 2, 2013
Frequent Mammograms Tied to Lower Risk of Breast Cancer Spread
Patients who had scans at shorter intervals had less lymph node involvement, study found
WEDNESDAY, Dec. 4, 2013 (HealthDay News) -- Breast cancer patients who have mammograms every 12 to 18 months have less chance of lymph node involvement than those who wait longer, therefore improving their outlook, according to an early new study.
As breast cancer progresses, cancer cells may spread to the lymph nodes and other parts of the body, requiring more extensive treatment.
"We found doing mammograms at intervals longer than one and a half years essentially does affect patient prognosis," said study researcher Dr. Lilian Wang. "In our study, those patients were found to have a significantly greater lymph node positivity."
From 2007 to 2010, Wang evaluated more than 300 women, all of whom were diagnosed with breast cancer found during a routine mammogram. She divided them into three groups, based on the interval between mammograms: less than one and a half years, one and a half to three years or more than three years. Most women were in the first category.
Wang looked to see how many women had cancer that had spread to their lymph nodes. Although nearly 9 percent of those in the shortest interval had lymph node involvement, 21 percent of those in the middle group and more than 15 percent in the longest-interval group did.
The stage at which the cancer was diagnosed did not differ among the groups, she found.
Although the study found an association between more frequent screenings and less lymph node involvement among breast cancer patients, it did not establish a cause-and-effect relationship.
Wang, an assistant professor of radiology at Northwestern University's Feinberg School of Medicine, is scheduled to present the findings Wednesday at the annual meeting of the Radiological Society of North America, in Chicago.
The best interval between routine mammograms has been a point of discussion and debate for years.
In 2009, the U.S. Preventive Services Task Force, an independent group of experts, changed their recommendations, which previously advised annual mammograms. The updated recommendations advised that women begin routine mammograms at age 50, and that every two years was an acceptable interval. Women aged 40 to 50 were advised to discuss the pros and cons of screening with their doctors.
The updated guidelines took into account death from breast cancer with different screening intervals and the downsides of false positives, which could translate into more testing, expense and anxiety.
Other organizations, however, including the American Cancer Society and the American College of Radiology, continue to recommend annual mammograms for women beginning at age 40.
The new results, Wang said, support the recommendations for annual testing beginning at age 40 for average-risk women.
The study disclosed that another co-author has served on boards or been a speaker for imaging-device manufacturers.
An expert not connected with the new study said its focus -- looking not at the risk of death from breast cancer, but the chances of cancer spreading to the lymph nodes -- is a legitimate one.
"If you catch someone with early stage cancer, they are going to need less extensive surgery, and maybe no chemo," said Dr. Laura Kruper, director of the Cooper-Finkel Women's Health Center at the City of Hope Cancer Center, in Duarte, Calif.
"[The new study] adds more power behind the fact that we do need screening mammograms starting at age 40 and every year," she said.
In a second study presented at the meeting, other researchers reported on a new technique that uses focused ultrasound under the MRI guidance to heat and destroy breast cancer tissue.
Researchers at Sapienza University, in Rome, evaluated the treatment in 12 breast cancer patients before surgical removal of their cancer and biopsy of their lymph nodes.
When the researchers looked at the tissue, no sign of tumor was found in 10 of the 12 patients. More research is needed, however, before the technique could be considered as a standalone treatment, the researchers said.
Kruper agreed. The new technique is far from being ready for clinical use, she said. Among the unanswered questions are how the results will stand up over time.
Because both studies were presented at a medical meeting, the data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.
To learn more about mammograms, visit the American Cancer Society (http://www.cancer.org/cancer/breastcancer/moreinformation/breastcancerearlydetection/breast-cancer-early-detection-acs-recs-mammograms ).
SOURCES: Lilian Wang, M.D., assistant professor of radiology, Northwestern University Feinberg School of Medicine, Chicago; Laura Kruper, M.D., director, Cooper-Finkel Women's Health Center, City of Hope Cancer Center, Duarte, Calif.; Dec. 4, 2013, presentations, Radiological Society of North America annual meeting, Chicago
Health Highlights: Dec. 4, 2013
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Anti-Seizure Drug Can Cause Serious Skin Reactions: FDA
In rare cases, the anti-seizure drug Onfi (clobazam) can cause serious skin reactions that can result in serious injury and death, the U.S. Food and Drug Administration says.
The drug is used in combination with other medications to treat seizures caused by a severe form of epilepsy called Lennox-Gastaut Syndrome. The drug's label and its patient Medication Guide have been changed to explain the risk, the FDA said.
The skin reactions -- called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) -- can occur at any time during Onfi treatment. However, the risk of skin reactions is greater during the first 8 weeks of treatment or when a patient stops taking Onfi and then starts taking it again.
All cases of SJS and TEN reported to the FDA have resulted in hospitalization, one case resulted in blindness, and one case resulted in death.
Patients taking Onfi should seek immediate medical treatment if they develop a rash, blistering or peeling of the skin, sores in the mouth, or hives, but patients should not stop taking the drug without first talking to their health care professionals, the FDA said.
Stopping Onfi suddenly can cause serious withdrawal problems, such as seizures that will not stop, hallucinations, shaking, nervousness, and stomach or muscle cramps.
Obama Announces $100 Million HIV Research Program
A $100 million National Institutes of Health initiative to pursue a cure for HIV was announced Monday by President Barack Obama.
He said the money will be used to develop a new generation of therapies, and also said the U.S. should be a leader in research to eliminate HIV or to force it into remission without the need for lifelong therapy, the Associated Press reported.
Obama made the announcement at a White House event marking World AIDS Day, which was Sunday.
He also said the U.S. had passed the goal he set last year to support 6 million HIV patients worldwide in getting access to anti-retroviral drugs. So far, the U.S. had helped 6.7 million people receive the life-saving treatment, the AP reported.
First Human Case of H7N9 Bird Flu Reported in Hong Kong
Hong Kong has reported its first human case of H7N9 bird flu.
The patient is a 36-year-old Indonesian maid who is in hospital in critical condition, according to Hong Kong Health Secretary Ko Wing-man, the Associated Press reported.
The maid was known to cross the border to the mainland Chinese city of Shenzhen to buy, slaughter and eat chickens, said Ko, who added that Hong Kong will step up its flu pandemic preparedness plan.
The H7N9 virus was first identified in mainland China in April and has since sickened 139 people and killed 45 in China and Taiwan. The spread of the virus appears to have stalled since Chinese authorities cracked down on live animal markets, the AP reported.
Even so, experts fear the virus will re-emerge this winter.
4th Meningitis Case Confirmed at California University
Another case of meningitis has been confirmed at the University of California, Santa Barbara and public health officials have urged the school to suspend parties and other social events on the campus.
The 18-year-old male student was the fourth case at UCSB in a month. One student has been left permanently disabled, NBC News reported.
The B strain of meningitis has been confirmed as the cause of three of the cases. The strain in the latest case still needs to be confirmed. The B strain of meningitis is not covered by the vaccine recommend for U.S. college students.
Princeton University in New Jersey has been hit by an outbreak of meningitis B, but it has a different genetic fingerprint than the strain in the UCSB cases, according to the Centers for Disease Control and Prevention, NBC News reported.
U.S. Bishops Face Lawsuit Over Catholic Hospitals' Abortion Policies
A lawsuit filed Friday against the United States Conference of Catholic Bishops says the group's anti-abortion orders to Catholic hospitals prevent proper care of pregnant women in medical distress, leading to medical negligence.
The suit was filed by the American Civil Liberties Union on behalf of a woman who says she was not given accurate information or care at a Catholic hospital in Michigan after her water broke at 18 weeks of pregnancy, The New York Times reported.
As a result of this failure by staff at Mercy Health Partners in Muskegon, Tamesha Means says she was exposed to dangerous infections. The suit alleges that the bishops' ethical and religious directives require Catholic hospitals to avoid abortions or referrals "even when doing so places a woman's health or life at risk."
The ACLU said it launched legal action against the bishops because there have been several cases in recent years in which Catholic hospital policies on abortion interfered with medical care, The Times reported.
Both the hospital and the bishops conference refused comment.
An advisor to the bishops could not speak about the ACLU lawsuit because he was unfamiliar with it. But John Haas, president of the National Catholics Bioethics Center in Philadelphia, told The Times that the bishops' directives do allow actions to treat women at risk, even if the treatment might cause the loss of the fetus.
Health Tip: Prevent Headaches in Teens
Enough regular sleep can help
(HealthDay News) -- Headaches are common among teenagers, whose busy and irregular schedules can be a prime factor.
The American Academy of Pediatrics suggests how teens can help prevent headaches:
Get an appropriate amount of sleep each night.
Eat meals on a consistent schedule.
Get regular physical activity.
Figure out any pattern of behavior that seems to trigger your headaches. If possible, avoid those activities.
Less Physical Activity, More TV for Today's Moms, Study Finds
This generation is less active than mothers in 1960s, researchers say
WEDNESDAY, Dec. 4, 2013 (HealthDay News) -- American mothers watch more TV and get less physical activity today than mothers did four decades ago, a new study finds.
"With each passing generation, mothers have become increasingly physically inactive, sedentary and obese, thereby potentially predisposing children to an increased risk of inactivity, adiposity [body fat] and chronic non-communicable diseases," said study leader Edward Archer, an exercise scientist and epidemiologist at the University of South Carolina.
"Given that physical activity is an absolute prerequisite for health and wellness, it is not surprising that inactivity is now a leading cause of death and disease in developed nations," Archer noted in a university news release.
The analysis of 45 years of national data focused on two groups of mothers: those with children 5 years or younger, and those with children aged 6 to 18. The researchers assessed physical activity related to cooking, cleaning and exercising.
From 1965 to 2010, the average amount of physical activity among mothers with younger children fell from 44 hours to less than 30 hours a week, resulting in a decrease in energy expenditure of 1,573 calories per week.
The average amount of physical activity among mothers with older children decreased from 32 hours to less than 21 hours a week, with a reduction in energy expenditure of 1,238 calories per week, the researchers found.
The findings mean that mothers in 2010 would have to eat 175 to 225 fewer calories per day to prevent weight gain than mothers in 1965, according to the study published in the December issue of the journal Mayo Clinic Proceedings.
These significant declines in physical activity corresponded with large increases in sedentary pastimes such as watching TV, the investigators noted. On average, sedentary behaviors increased from 18 hours a week in 1965 to 25 hours a week in 2010 among mothers with older children, and from 17 hours a week to nearly 23 hours a week among mothers with younger children.
Compared to working mothers, stay-at-home moms had about twice the decrease in physical activity and much larger increases in sedentary behaviors, according to the report.
The findings provide important insights into the growing problems of childhood obesity and diabetes in the United States, the study authors noted in the news release.
"The confluence of our results and other research suggests that inactivity has increased significantly over the past 45 years and may be the greatest public health crisis facing the world today," Archer said in the news release.
The U.S. Office on Women's Health has more about physical activity (http://womenshealth.gov/publications/our-publications/fact-sheet/physical-activity.html ).
SOURCE: University of South Carolina, news release, Dec. 2, 2013
Lifestyle Factors Impact Risk of Hearing Loss in Women
Higher BMI, larger waist circumference positively linked to risk; physical activity inversely linked
WEDNESDAY, Dec. 4, 2013 (HealthDay News) -- Higher body mass index (BMI) and larger waist circumference are positively associated, and physical activity is inversely associated, with the risk of self-reported hearing loss, according to a study published in the December issue of the American Journal of Medicine.
Sharon G. Curhan, M.D., from Brigham and Women's Hospital in Boston, and colleagues assessed the independent correlations between BMI, waist circumference, and physical activity with self-reported hearing loss in a cohort of 68,421 women from the Nurses' Health Study II from 1989 to 2009.
After more than 1.1 million person-years of follow-up, the researchers identified 11,286 cases of self-reported hearing loss. The risk of hearing loss was increased with higher BMI and larger waist circumference. The multivariate adjusted relative risk for hearing loss was 1.25 for women with a BMI ≥40 kg/m² versus <25 kg/m². For women with a waist circumference of >88 cm versus <71 cm, the multivariate-adjusted relative risk was 1.27. There was an inverse association between physical activity and risk, with a multivariate-adjusted relative risk of 0.83 for women in the highest versus the lowest quintile of physical activity. There was an inverse association between walking two or more hours per week and risk. The associations were slightly attenuated after simultaneous adjustment for BMI, waist circumference, and physical activity, but remained statistically significant.
"These findings provide evidence that maintaining healthy weight and staying physically active, potentially modifiable lifestyle factors, may help reduce the risk of hearing loss," the authors write.
Abstract (http://www.amjmed.com/article/S0002-9343(13)00673-6/abstract )Full Text (subscription or payment may be required) (http://www.amjmed.com/article/S0002-9343(13)00673-6/fulltext )