Tuesday, April 24, 2012
Gene points to Achilles' heel in MRSA superbug
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Nestle wins pricey battle for Pfizer baby food unit
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Thomson Reuters sells healthcare unit to Veritas
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HeartWare shares up as FDA safety review minimized
However, analysts said the review by Food and Drug Administration staff raised few new issues and bet the device would be approved, sending HeartWare shares up 4.3 percent to $70.01 in morning trading on Nasdaq.
FDA staff also said clinical trial results for the mechanical heart-assist device, or the HeartWare ventricular assist device (HVAD), may have missing data and are difficult to compare with a registry of patients.
In clinical trials, HeartWare compared patients who got its device to a registry, or database, of patients with mechanically assisted circulatory support. It was the first blood pump trial to use a registry as a control arm.
FDA staff said the registry may have had more people who were critically ill, skewing results in favor of HeartWare's pump.
The staff also said 16 of the 250 people implanted with HeartWare's device had blood clot-related pump failure, and 15 of them needed to replace their pumps. HeartWare said people who needed to a new device should not be considered as failures.
"(But) FDA continues to believe that the need for device exchange is a relevant consideration when assessing the device's safety and effectiveness and seeks panel input on this issue," the FDA staff said in documents posted online on Monday.
The FDA staff review comes ahead of a meeting of outside experts who were due to vote on the device on Wednesday. The FDA will make a final decision later.
Heart failure is a chronic and incurable condition, in which the heart is too weak to pump enough blood to meet the body's needs. In the most severe cases, people may need a heart transplant.
HeartWare's device helps people with failing hearts pump blood while awaiting a heart transplant. The device is already approved in Europe.
It is estimated that some 50,000 people around the world are candidates for heart transplant, but only some 5,000 patients per year get them.
If approved, the device will compete with Thoratec Corp's HeartMate II, which has been sold in the United States since 2008. It is currently the only blood pump available to people with heart failure who are waiting for a transplant.
Larry Biegelsen, analyst at Wells Fargo, said the FDA review did not contain any major surprises.
"We believe the overall success of the pivotal trial and FDA's desire to have an alternative pump on the market to Thoratec's HeartMate II will result in approval of the HVAD later this year," he said in a research note.
Many investors have been betting HeartWare's device will eventually eclipse the HeartMate II since it is smaller and takes less time to implant. However, concerns about pump-associated thrombosis, or the formation of blood clots, as well as stroke issues, could hurt market share.
Biegelsen said the higher stroke rate with HeartWare's device, especially compared to the Thoratec device, will be the greatest challenge during the panel on Wednesday.
The FDA said 8 percent of patients who got HeartWare's blood pump during clinical trials had an ischemic stroke, compared to a rate of 5 to 6 percent in trials of other devices. In an ischemic stroke, a blood vessel that supplies blood to the brain is blocked by a clot.
HeartWare is also testing its device as a long-term treatment for patients who are not eligible for a heart transplant or may not be able to get one.
(Reporting by Anna Yukhananov; Editing by Gerald E. McCormick, Maureen Bavdek, Dave Zimmerman)
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Aspirin tied to lower lung cancer risk in women
The findings, which link regularly taking aspirin to a risk reduction of 50 percent or more, do not prove that aspirin directly protects against lung cancer. There may be other explanations for the connection.
But the study backs up a number of previous ones linking regular aspirin use to lower risks of certain cancers, including colon, prostate and esophageal cancers.
Still, experts say it's too early to recommend widespread aspirin use for cutting cancer risk.
Even low-dose aspirin carries risks, like stomach irritation and ulcers.
"The question about whether aspirin use protects against lung cancer is still open to considerable debate at this point, and the published evidence to date is not conclusive," Dr. Wei-Yen Lim, who led the new study, said in an email.
Avoiding tobacco smoke remains the best way to protect yourself, said Lim, of the National University of Singapore.
Published in the journal Lung Cancer, the study included 398 Chinese women diagnosed with lung cancer and 814 cancer-free women.
Lim's team found that women who had used aspirin regularly -- at least twice a week for one month or longer -- were less likely to have lung cancer.
Among women who'd never smoked, the odds were 50 percent lower for aspirin users versus non-users. And among smokers, aspirin use was tied to a 62 percent lower risk of lung cancer.
The researchers were able to account for some other factors, like the women's age, education and fruit and vegetable intake. But there could still be other differences that would help explain why aspirin users had a lower lung cancer risk, according to Lim.
This type of study, the researcher said, is not designed to show whether taking aspirin cuts cancer risk. That takes a clinical trial, where people are randomly assigned to take aspirin or not.
And the findings do not give an idea of how much risk-reduction there might be.
There was a fairly large relative difference in cancer risk between aspirin users and non-users in the study. But the absolute reduction in any one person's risk, if there is one, might be small.
Other studies have linked regular aspirin use to lower risks of several types of cancer. Most recently, an analysis of past clinical trials found that people given daily low-dose aspirin were less likely to develop cancer after three years of use. (See Reuters story of March 21, 2012.)
Aspirin appeared to prevent about three cases of cancer per 1,000 aspirin users per year.
There are also biological reasons that aspirin might offer protection: it blocks an enzyme called cyclooxygenase-2, or COX-2, which promotes inflammation and cell division and is found in high levels in tumors.
Dr. Andrew T. Chan of Harvard Medical School, who was not involved in the study, said that the evidence on aspirin and lung cancer has been "mixed."
"The number-one thing a person can do to minimize the risk of lung cancer is to not smoke," he said in an interview.
On the other hand, there is stronger evidence that aspirin may be protective against colon cancer, according to Chan, a gastroenterologist who researches colon cancer prevention.
"I don't think the evidence is definitive," Chan said. And it's too soon to recommend that all middle-aged and older adults take a daily aspirin.
But it may be reasonable for people to discuss the pros and cons of low-dose aspirin with their doctors, according to Chan.
"People are usually interested in more than preventing one particular cancer," he noted. "So it's important to view this in the context of a person's overall health."
That includes understanding the risks of aspirin. For many people, gastrointestinal side effects may be "minor," Chan said.
But some people can develop bleeding ulcers. Aspirin is also linked to an increased risk of hemorrhagic stroke -- bleeding in or around the brain.
Many middle-aged and older adults already take daily aspirin for their cardiovascular health.
The U.S. Preventive Services Task Force recommends that men age 45 to 79 take aspirin to prevent heart attacks, as long as their personal benefit is likely to outweigh the risk of bleeding. For women age 55 to 79, aspirin is recommended to prevent ischemic strokes (strokes caused by a blood clot), with the same caveat.
Lim said that if your doctor has recommended aspirin to you, stick with that advice.
"For people who are currently well," the researcher said, "we do not recommend taking aspirin to reduce their risk of lung cancer, as the effect of aspirin on lung cancer is still being evaluated."
SOURCE: http://bit.ly/IzaxsH Lung Cancer, online April 3, 2012.
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Stricter Seat Belt Laws Get Teens to Buckle Up, Study Shows
A primary law allows police to stop and ticket drivers solely for not wearing a seat belt. Under a secondary law, police can only ticket unbelted drivers if they are stopped for other reasons, such as speeding.
Primary seat belt laws have been proven to reduce death rates in traffic collisions, according to the report published in the April 19 online edition of the American Journal of Public Health.
In the new study, researchers examined data from more than 3,000 U.S. high school student drivers who took part in the 2006 National Young Driver Survey. The analysis revealed that teens in states with secondary laws were 12 percent less likely to wear a seat belt when driving and 15 percent less likely to do so as a passenger than teens in states with primary laws.
In addition, the investigators found that in states with secondary laws, teens' use of seat belts decreased as they progressed from learner to unrestricted license holder. This did not occur in states with primary laws.
The findings also revealed that blacks, rural residents, academically challenged students and those who drove pick-up trucks had particularly low rates of seat belt use.
"This study showed that primary-enforcement safety belt laws may play a key role in mitigating the disparity in safety belt use among certain teenaged subpopulation groups," lead study author Dr. J. Felipe Garcia-Espana, of the Center for Injury Research and Prevention at the Children's Hospital of Philadelphia, said in a journal news release.
"Because some teenaged subpopulations have lower safety belt use, even with primary enforcement laws, combined approaches that include upgrades to laws with campaigns and enforcement might be warranted," the study authors concluded.
More information
The U.S. Centers for Disease Control and Prevention says parents are the key to safe teen drivers.
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Shingles Vaccine Safe, Underutilized, Study Says
Shingles, which affects more than 1 million people each year in the United States, is a painful contagious rash caused by the dormant chickenpox virus, which can reactivate and replicate, damaging the nervous system.
Elderly people are especially at risk because immunity against the virus that causes shingles declines with age.
In this study, researchers looked at data from more than 193,000 adults 50 and older who received the shingles vaccine, also known as the herpes zoster vaccine, over two years. There was a small increased risk of local reactions (redness and pain) from one to seven days after vaccination. This finding matches the results of clinical trials.
The shingles vaccine did not increase the risk for cerebrovascular diseases; cardiovascular diseases; meningitis, encephalitis, and encephalopathy; Ramsay-Hunt syndrome; or Bell's palsy, the researchers said.
The study was published online April 23 in the Journal of Internal Medicine.
The study supports the vaccination recommendation from the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices "and reassures the general public that the vaccine is safe," study author Hung Fu Tseng, a research scientist with the Kaiser Permanente in Pasadena, Calif., said in a Kaiser news release.
Few people received the vaccine, which was licensed in 2006, the news release said. The CDC recommends it for healthy people aged 60 and older.
More information
The U.S. National Institute of Neurological Disorders and Stroke has more about shingles.
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Hispanics Seem to Have Better Odds of Lung Cancer Survival
Researchers say Hispanics' increased likelihood of survival may be due to genetic factors or environmental advantages, such as lower rates of tobacco use.
In the study, the researchers examined diagnosis and survival data on cancer patients from a national database that pooled information from U.S. cancer registries.
They identified 172,000 adults diagnosed with any stage of the most common form of lung cancer, known as non-small cell lung cancer, between 1988 and 2007. Of these patients, Hispanics had a 15 percent lower risk of death during the study than whites. This was true for both U.S.- and foreign-born Hispanics.
The study, published online in the journal Cancer, pointed out that Hispanics tend to have better odds of survival despite facing more obstacles to health care and higher rates of poverty than other groups.
"This is important because it shows that our findings are indicative of the Hispanic population in general and not specific to specific groups of Hispanics," lead study author Ali Saeed, an M.D./Ph.D. candidate at University of Miami Miller School of Medicine, said in a journal news release.
The study's authors added that the white patients who were studied had a slightly higher likelihood of survival than those who were black. Hispanics were more likely to be diagnosed with a less serious form of lung cancer, known as bronchioalveolar carcinoma.
"Our findings will motivate researchers and physicians to understand why Hispanics have more favorable outcomes and may shed light on potential environmental factors and/or genetic factors that can explain our observations," said Saeed. "For instance, the fact that Hispanics developed higher frequencies of bronchioalveolar carcinoma could be due to genetic predispositions and/or their lower smoking rates."
More information
The U.S. National Library of Medicine has more about lung cancer.
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Health Tip: Overcoming Obstacles to Exercise
The American Council on Exercise offers these possible solutions to combatting exercise "saboteurs":
When you're stressed out, schedule time for even a very short workout. Exercise is a great way to fight intense stress, the council says.Don't set unrealistic expectations, which can only result in frustration. Set goals that challenge you, but are attainable.Avoid overtraining, which can slow your progress. Instead, schedule some down time to help your body rest and recover.When something unexpected comes up, adjust your workout plan accordingly, but don't eliminate exercise entirely.Pump up and motivate yourself with positive thoughts.View the Original article
Health Tip: Recognize Common Symptoms of Menopause
The Womenshealth.gov website mentions these common symptoms of menopause:
Irregular periods.Hot flashes.Difficulty sleeping.Mood changes.Loss of interest in sex.Osteoporosis, weight gain or muscle loss.View the Original article
'Publication Bias' Casts Doubt on Value of Antidepressants for Autism
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Health Highlights: April 23, 2012
Scrap Medicare Bonus Program for Insurers: GAO
An $8 billion Medicare demonstration program that provides bonuses as a way to improve the quality of Medicare Advantage insurance plans should be cancelled, according to a U.S. Government Accountability Office report to be released Monday.
The government auditors said most of the bonus money is going to plans rated average, which means they receive three to three-and-a-half stars on Medicare's five-star rating scale, the Associated Press reported.
There's no evidence that the bonus program will improve the quality of Medicare Advantage plans, the GAO said.
The Obama administration said it disagrees with the GAO findings and insists the bonus program will improve the quality of care, the AP reported.
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160 Now Sickened in Tuna-Linked Salmonella Outbreak
A salmonella outbreak linked to a frozen yellowfin tuna product has now sickened 160 people in 20 states and the District of Columbia, the U.S. Centers for Disease Control and Prevention said late Tuesday.
In a statement, the agency said 26 people have been hospitalized but there have been no deaths reported.
On Monday, nearly 59,000 pounds of the product, labeled Nakaochi Scrape AA or AAA, was recalled by Moon Marine USA Corp. of Cupertino, Calif. The product, which is scraped off fish bones, was sold to grocery stores and restaurants to make dishes such as sushi, sashimi and ceviche.
As reported by the Associated Press, many people who became ill reported eating raw tuna in sushi as "spicy tuna."
As of Friday, the CDC said illnesses linked to the recalled product had been reported in: Alabama (2), Arkansas (1), Connecticut (6), District of Columbia (2), Florida (1), Georgia (6), Illinois (14), Louisiana (3), Maryland (14), Massachusetts (23), Mississippi (2), Missouri (4), New Jersey (8), New York (30), North Carolina (3), Pennsylvania (6), Rhode Island (5), South Carolina (3), Texas (4), Virginia (9) and Wisconsin (14).
The CDC noted that salmonella illness is often serious for infants, older adults, pregnant women and persons with impaired immune systems, and these individuals should not eat raw or partially cooked fish or shellfish.
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U.S. Women Trail Men in Life Span Gains: Study
American men's lifespans increased by an average of 4.6 years between 1989 and 2009, while women's increased by only 2.7 years, a new study says.
It also found large variations in average county-to-county life spans across the nation, ranging from 66.1 to 81.6 years for men and 73.5 to 86 years for women, USA Today reported. In many counties, women's life spans are shorter than they were 20 years ago.
Even though women are still expected to outlive men by 4 years, these finding are cause for concern, according to the study by researchers at the Institute for Health Metrics and Evaluation at the University of Washington.
"A gain in life expectancy should be equal among men and women," said research team director Ali Mokdad, USA Today reported. "This is a wake-up call for all of us. It's tragic that in a country as wealthy as the United States, and with all the medical expertise we have, that so many girls will live shorter lives than their mothers."
Preventable causes of death, such as smoking, obesity and alcohol, are key reasons for the differences between men and women.
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