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This Month's Articles:

Awareness: Routine Tests Urged for Balance Problems

Boomer men and women in denial about hearing loss

Study: Many Kids Not Getting Their Zzzzs

Women Lag Behind Men in Cancer Trial Representation

Senate Passes Bill to Let FDA Regulate Tobacco

Study: Sinus Infections Tied to Toxic Shock Syndrome in Children

F.D.A. Warns Against Use of Popular Cold Remedy

APSS: Sleep Apnea Not Limited to Obese Patients

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June 2009 News Archives


June 1: Awareness: Routine Tests Urged for Balance Problems, The New York Times


By ERIC NAGOURNEY

Millions of people may suffer from inner-ear disorders that affect their balance but not be aware that they have a problem, a new study has found.

Writing in The Archives of Internal Medicine, researchers noted the connection between balance problems and falls, especially among the elderly.

The findings of the study, they said, suggest that doctors should make balance tests a routine part of checkups. This is especially true in nursing and assisted-living homes, they said.

“The big deal here really is falls,” the lead author, Dr. Yuri Agrawal of Johns Hopkins, said in an e-mail message, adding that a serious fall can be the beginning of the end for an older patient.

The researchers drew on data from a federal study in which more than 5,000 people age 40 and over were surveyed about their history of falls and balance problems. They were then given examinations to determine how well they could maintain their balance in a variety of situations, including with their eyes closed.

More than a third of the subjects, the researchers found, had the balance disorder known as vestibular dysfunction — a figure that would translate to 69 million Americans.

They also found that 32 percent of the volunteers who did not report problems with dizziness showed evidence of balance problems. Though they did not experience symptoms, they were still at higher risk for falls, the study said.

For doctors, Dr. Agrawal said, detecting balance problems in a patient is not very complicated. And treatment is available, including exercises that help people compensate for inner-ear problems that lead to poor balance.

The cost of the treatment, they said, would most likely be less than medical costs associated with falls.


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June 2: Boomer men and women in denial about hearing loss, examiner.com


A new survey finds that Baby Boomers think their hearing is just fine, thank you.

The children of those same folks, however, think mom and dad should be checked out for a hearing aid.

Siemens Hearing Instruments in a recent survey of 250 Baby Boomers and 250 of their children found:
  • 72 percent of the Baby Boomers survey believed their hearing is average or better;
  • 70 percent of children with a Boomer father have suggested that he have his hearing tested;
  • 64 percent have suggested the same for their Boomer mother.
"Older Americans are in denial about their hearing loss and are unaware of the negative consequences of an undiagnosed hearing loss," Dr. Tom Powers, vice president of Audiology and Compliance at Siemens Hearing, said in a statement.

"By taking the proper steps to have their hearing tested and treated, Boomers can greatly increase their quality of life, not only through the increased sounds around them, but through greatly enriched relationships with their friends and family."

The survey also revealed some social consequences of poor hearing:
  • 54 percent of respondents perceive depression in their father and 50 percent report the same for their mother because of a lack of hearing;
  • 53 percent of children perceive isolation on the part of their father and 49 percent for their mother;
  • 58 percent of children respondents perceive anger on the part of their father, while 50 percent feel the same about their mother.
According to a WebMD report: About 14 percent of people between ages 45 and 64 have hearing loss (an increase of 26 percent in this age group since 1971). And as the baby boomers continue to age, the incidence of hearing loss is expected to grow.

The WebMD report also captures the sense that a loss of hearing can affect a person's place in society.

"The scenario is much too common -- and often too painful -- for men and women in their 40s and 50s," it said. "They might sit silently at dinner parties, having difficulty following the conversation. They may feel completely lost when attending the theater, straining to hear what the actors are saying."


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June 8: Study: Many Kids Not Getting Their Zzzzs, CBS News


New Reasearch Says Many Children Go Undiagnosed For Sleep Disorders, Dr. Jennifer Ashton Discusses What You Need To Know

Is your child sleeping well?

About one in four children don't, but their problems are often missed, according to new research from The American Academy of Sleep Medicine that suggests pediatricians may be under-diagnosing sleep disorders in children.

CBS News medical correspondent Dr. Jennifer Ashton discussed the study on The Early Show Monday, and what you can look for and do if you think your child is suffering from a sleep disorder.

The study found only four percent of 150,000 children researched in Pennsylvania, from birth to age 18, were diagnosed with a disorder, which is substantially less than the estimated 25 percent of children who suffer from a sleep disorder in larger studies.

Undiagnosed disorders, such as insomnia, sleep apnea, night terrors, sleepwalking, snoring, grinding teeth, and bedwetting, Ashton said, are all disruptions in sleep that can impact a child's learning, growth and development.

Early Show co-anchor Harry Smith asked Ashton what warning signs indicate sleep problems.

She said children that snore loudly, wake up repeatedly, have mood or school performance changes, or fall asleep during the day may have sleep disorders.

Ashton said if you think your child is suffering from a sleep disorder, you should collect information and observations about your child and bring them to your pediatrician. She added parents should ask if it would be helpful to do a sleep study or a consultation with an ear, nose and throat specialist to check if enlarged tonsils may not be the cause.

"But don't ignore it," Ashton warned. "These things can really have significant impacts on our kids in a very critical time."

Smith asked if obesity has an influence on sleeping disorders.

Ashton said it can be an issue in cases of sleep apnea, but in many cases the problem is behavioral, which many children grow out of as they develop.

How do you tell if your child's snoring problem is serious? Many children snore, especially if they have a cold or seasonal allergies. But snoring that can indicate a problem is usually louder and more irregular than the run-of-the-mill soft snoring that many children experience. Especially concerning could be snoring that is also accompanied by brief episodes where the child stops breathing. These are called apneic episodes. Many children with this type of sleep disorder can have excessively large tonsils and/or adenoids. These children should be evaluated by a Pediatric ENT (or Ear, Nose and Throat specialist) who can tell you if surgery is an option. According to Dr. Nina Shapiro, Director of Pediatric Otolaryngology at UCLA, some children will "grow out" of tonsil problems if they are mild and the child is slightly older (around 6 years of age). Younger children with very large tonsils and disordered breathing/sleep disruption are more likely to be candidates for surgery to treat this problem.

To help your child fall asleep, Ashton recommended these tips:
  • Avoid caffeine in your child's diet
  • Emphasizing a bedtime routine
  • Make the child's bedroom conducive to sleep with a dark, cool and quiet atmosphere
  • Keep television and computers out of the bedroom

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June 8: Women Lag Behind Men in Cancer Trial Representation, MedPage Today


By Charles Bankhead, Staff Writer, MedPage Today
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

HOUSTON, June 8 -- More than a decade after the government urged scientists to enroll more women in clinical research projects, females were still significantly under-represented in clinical trials involving nonsex-specific cancers, a review of more than 600 studies showed.

Women accounted for less than 40% of patients in these trials and were significantly lacking in trials involving six of seven nonsex-specific cancers, Reshmi Jagsi, M.D., D.Phil., of the University of Michigan in Ann Arbor, and colleagues reported online in Cancer.

The researchers also found that trials with government funding had significantly more women than privately funded studies.

"Only by understanding the forces affecting the sex distribution of study subjects can we as a society succeed in ensuring that our medical research efforts are inclusive and to the benefit of all," the authors concluded.

The Revitalization Act of 1993 emphasized the need to include women in clinical research projects. In a 2001 report, the Institute of Medicine identified gender as a basic variable in the design and analysis of clinical studies.

Whether women are adequately represented in clinical trials remains an unresolved issue, Dr. Jagsi and colleagues said.

For example, a review of federally funded studies published in medical journals in 2004 showed that women constituted 37% of participants in nonsex-specific trials.

Studies of participation in cancer-specific research have yielded conflicting results.

So, to update the current status of women's representation in clinical cancer studies, the authors reviewed articles published in 2006 in eight major journals.

They identified 1,534 cancer research articles, including 661 pertaining to prospective clinical studies involving a total of 1,096,098 participants. The prospective studies formed the basis for the primary analyses.

The authors analyzed the studies with respect to seven nonsex-specific cancer types: central nervous system, gastrointestinal, head and neck, hematologic, lung, sarcoma, and urinary.

They compared women participants in the studies to the number of females that would be expected on the basis of sex distribution for that that type of cancer.

The estimated incidence of specific cancers in women was based on data from the U.S. Bureau of Census and the National Cancer Institute.

"For six of seven cancer types analyzed, the overall percentage of women among treatment study participants was significantly (P<0.001) lower than the percentage expected based on general population incidence data," the authors said.

Overall, women accounted for 38.8% of participants in studies of nonsex-specific cancers. Studies focusing on treatment had an even lower percentage of women compared with studies focusing on other aspects of cancer (36.9% versus 42.2%, P=0.004).

Female participation was higher in government-funded studies: 41.3% versus 36.9% in studies funded by other sources (P=0.005).

Studies whose first or senior author was a woman also had a higher proportion of female participants than studies led by males (41.3% versus 37.3%, P=0.01).

In a multivariate analysis, lack of government funding and a focus on cancer treatment were independent predictors of a lower percentage of female participants (P=0.03).

Limitation of the study included focus on high-impact published studies in a single year, assessment of participants in published articles rather than trial enrollment, inability to evaluate other factors such as race and socioeconomic status, and inclusion of both study as a whole and individual participants as units of measure.


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June 12: Senate Passes Bill to Let FDA Regulate Tobacco, The Washington Post


By Lyndsey Layton
Washington Post Staff Writer

Landmark legislation approved by the Senate yesterday will give the federal government sweeping new powers to oversee tobacco products, allowing regulators to control factors including the amount of addictive nicotine in a cigarette and how that cigarette is packaged and marketed.

For the 20 percent of Americans who smoke, the law will mean confronting more graphic warnings of the risks of their habit every time they pick up a pack. The law also bans most cigarette flavorings.

For the $89 billion tobacco industry, it will mean new requirements to disclose the ingredients in cigarettes and other tobacco products, and severe limitations on how they are advertised and promoted. The government could also issue new rules on nicotine content, flavorings and other product features.

Many of the new restrictions are aimed at preventing children from starting to smoke. Cherry and other fruit flavorings that appeal to children will be banned, along with marketing aimed at younger smokers, such as the use of Joe Camel and other cartoon characters.

The 79 to 17 vote virtually ensured that the bill will become law. The measure now goes to the House, which passed a nearly identical version in April and could take a final vote today. President Obama, himself a smoker who has struggled to quit, has said he will sign it.

Congress has been battling for more than a decade over regulating tobacco, coming close several times but faltering in the face of opposition from the tobacco lobby or the White House or procedural hang-ups. But over the years, changing social attitudes toward smoking have helped transform the idea of regulation from controversial to common sense.

"There's been a fundamental sea change in attitudes about tobacco in both the Congress and the public," said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, which led a coalition of more than 1,000 public health and faith organizations that supported the legislation. "A bill this broad, comprehensive, this strong would have been unimaginable even five years ago."

The legislation, which comes 50 years after the surgeon general first warned about the health effects of tobacco, gives broad new authority to the Food and Drug Administration to regulate the manufacturing and marketing of tobacco products.

"Miracles still happen," the bill's sponsor, Sen. Edward M. Kennedy (D-Mass.), said in a statement. Kennedy, who had worked for years to push the bill forward, is battling brain cancer and missed yesterday's vote. "The United States Senate has finally said 'no' to Big Tobacco."

On the Senate floor, lawmakers took turns detailing their personal struggles with tobacco.

"There's not a smoker in the country that's an adult who wishes their children would begin smoking," said Sen. Christopher J. Dodd (D-Conn.), himself a former smoker. "And there are many adult smokers today who wish they never started. . . . This has been a very long battle."

Sen. Richard Burr (R-N.C.), whose state is home to the R.J. Reynolds and Lorillard tobacco companies, tried to kill the measure, arguing that the FDA cannot handle additional duties. But in the end, he could not gather enough support for a filibuster. His colleague from North Carolina, Sen. Kay Hagan, was the only Democrat to vote against the bill.


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June 15: Study: Sinus Infections Tied to Toxic Shock Syndrome in Children, FoxNews.com


Sinus infections may cause more than 20 percent of all cases of toxic shock syndrome in children, U.S. researchers said Monday.

They said doctors treating children for toxic shock syndrome should be aware of the risk.

"Prompt imaging studies of the sinuses is mandatory when no apparent cause of toxic shock syndrome is found," Dr. Kenny Chan of the University of Colorado and the Children's Hospital of Denver, whose study appears in the Archives of Otolaryngology, said in a statement.

Chan said most people associate toxic shock syndrome with tampons used by menstruating women but it can affect men and children, too. It is caused by toxins produced by bacteria, and can cause fever, rash, low blood pressure, and in rare cases, death.

While some cases had been seen after sinus surgery, little is known about sinus infections as a cause, particularly in children.

Chan and colleagues analyzed the medical records of 76 children who had toxic shock syndrome between 1983 and 2000.

They found 23 also had either acute or chronic sinus infections. Sinus infections were the primary cause of toxic shock in 21 percent of the cases — many of which were serious. Ten of the children were admitted to the intensive care unit, four needed drugs to raise their blood pressure and six needed surgery.

"It is imperative that physicians, particularly those who are providing intensive care to children, recognize that rhinosinusitis can be the sole cause of toxic shock syndrome in children," Chan and colleagues wrote


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June 16: F.D.A. Warns Against Use of Popular Cold Remedy, The New York Times


By GARDINER HARRIS

Federal drug regulators warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell.

The action is an early indication that the Obama administration is likely to take far more aggressive enforcement actions against drug companies than the Bush administration did.

The Food and Drug Administration received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, Ariz., first introduced the products.

In 2006, Matrixx paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell, a condition known as anosmia. Hundreds more such suits have since been filed.

Although the F.D.A. took no action during the Bush administration, Dr. Margaret A. Hamburg, who was named the agency commissioner by President Obama, said the incidence of anosmia associated with Zicam “strikes us as a fairly large problem.”

The agency issued its consumer alert even though Matrixx refused to recall its products, a highly unusual event. In a news release, Matrixx said it had suspended shipments of Zicam and would reimburse customers who wanted a refund.

“Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia,” the release said. “For this reason, Matrixx Initiatives believes that the F.D.A. action is unwarranted and will seek a meeting with the F.D.A. to review the company’s product safety data.”

Matrixx had $101 million in sales last year, of which $40 million came from Zicam products. Because Matrixx has called Zicam a homeopathic product, the company was not required to seek agency approval before selling it.

The F.D.A. does not have the power to order product recalls but must rely on manufacturers to do so voluntarily. Bills now moving through Congress would give the agency that power. Bush administration appointees said the F.D.A. did not need mandatory recall authority because companies always withdrew unsafe products when asked.

But the government sometimes negotiated for days or weeks before companies agreed to recalls, leading many more consumers to be put at risk. And the Zicam case demonstrates that aggressive enforcement action can lead to disagreements.

An F.D.A. warning letter sent to Matrixx on Tuesday states that Zicam Cold Remedy intranasal products “may pose a serious risk to consumers who use them” and are “misbranded.” Such language would normally describe a recall alert. The products have no proven benefits.

Matrixx has received more than 800 reports of Zicam users losing their sense of smell but did not provide those reports to the F.D.A., said Deborah M. Autor, director of compliance in the agency’s drug center. The law requires producers of approved drugs to forward to the F.D.A. all reports of product-related injuries, but Ms. Autor declined to say whether this reporting requirement applied to Matrixx.

“This disabling loss of one of the five senses may be long lasting or even permanent in some people,” Ms. Autor said. “People without the sense of smell may not be able to detect dangers such as gas leaks or smoke. They could lose much of the pleasure of eating, adversely impacting the quality of life.”

Dr. Charles E. Lee, a compliance officer in the agency’s drug center, said zinc could be toxic to nerve receptors in the nose. In the 1930s, intranasal zinc was tested as a polio preventative, and some patients suffered anosmia, Dr. Lee said.


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June 17: APSS: Sleep Apnea Not Limited to Obese Patients, MedPage Today


By Paula Moyer, Contributing Writer, MedPage Today
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

SEATTLE, June 17 -- Obstructive sleep apnea was the culprit in half of patients with relatively normal weight who complained of daytime sleepiness, researchers said here.

That finding emerged from a review of findings from more than 28,500 patients who underwent polysomnography at a network of 18 sleep centers, said principal investigator Tiemur Yeligulashvili, PhD, clinical supervisor of SleepTech in Wayne, N.J.

Dr. Yeligulashvili said that 54% of normal weight persons who underwent polysomnography were diagnosed with obstructive sleep apnea (OSA).

Dr. Yeligulashvili reported the finding at the annual meeting of the Associated Professional Sleep Societies.

"Previous studies were showing that among patients like this, about 28% were diagnosed," Dr. Yeligulashvili said. "So this is significantly different."

Lisa Shives, MD, the medical director of Northshore Sleep Medicine in Evanston, Ill., said the findings were somewhat counterintuitive since "many sleep specialists, when they see a thin person sitting in front of them, don't think 'sleep apnea' right away."

"This is a really powerful percentage here: 54% had OSA, and of that 54%, half had moderate-to-severe disease. If a thin patient has symptoms suspicious of OSA, find out why first before prescribing a sleep aid," she said. Dr. Shives was not involved in the study, but commented on its findings for MedPage Today.

Dr. Yeligulashvili stressed that all of the 28,583 patients had complained of excessive daytime somnolence and had therefore been referred to sleep centers to be screened for OSA.

Nineteen percent of the patients -- 5,426 -- were normal weight, which was defined as a body mass index of 27 kg/m2 or lower. Among those with normal BMIs, 2,906 (54%) had OSA, and among those with OSA, 1,441 had moderate-to-severe disease, defined as having an apnea-hypopnea index of more than 5. The remaining 1,465 (50.4%) had mild disease.

Among normal-weight people, the conventional OSA risk factors -- male gender, neck size, and Epworth Sleepiness Scale scores -- were not significantly associated with a diagnosis of OSA. However, among those with moderate-to-severe disease, male gender and large neck size were significantly linked (P<0.005 for each).

Asked about clinical implications, Dr. Yeligulashvili said that portable monitors are often used to detect OSA, but those monitors might be a poor choice for normal weight patients since the portable units often miss low apnea-hypoxnea index scores. Half of the normal weight people had mild disease with low apnea-hypoxnea index scores, which suggests that portable units would not be the optimal diagnostic tool for use in normal weight patients.

The study received no outside funding, Dr. Yeligulashvili said. Both Dr. Yeligulashvili and Dr. Shives said they had no financial disclosures with regard to this report.

Primary source: Association of Professional Sleep Societies

Source reference: Yeligulashvili T "Obstructive sleep apnea in non-obese patients: age, gender and severity" SLEEP 2009; 32: A186.


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