HealthDay, 11/20/08 (http://healthday.com/Article.asp?AID=621494)

The lack of sunshine during winter may diminish vitamin D levels in the body and harm cardiovascular health, U.S. researchers say.

The body needs sunshine to produce vitamin D, but that process is slowed in the winter due to less daylight and spending more time indoors.

“Chronic vitamin D deficiency may be a culprit in heart disease, high blood pressure and metabolic syndrome,” study author Sue Penckofer, a professor at the Marcella Niehoff School of Nursing at Loyola University in Chicago, said in a university news release.

She and her colleagues reviewed a number of studies that linked vitamin D deficiency to heart disease. The studies said rates of severe heart disease or death may be 30 percent to 50 percent higher in sun-deprived heart disease patients.

Diet alone isn’t sufficient to manage vitamin D levels, Penckofer and her team concluded. Treatment options, such as vitamin D2 or D3, may decrease the risk of severe heart disease or death. The preferred range in the body is 30-60 ng/mL of 25 (OH) vitamin D.

“Most physicians do not routinely test for vitamin D deficiency. However, most experts would agree that adults at risk for heart disease and others who experience fatigue, joint pain, or depression should have their vitamin D levels measured,” Penckofer said.

The study was published in the current issue of the journal Circulation.

HealthDay, 11/20/08 (http://healthday.com/Article.asp?AID=621486)

The stress of providing care for a loved one with Alzheimer’s results in 25 percent of family caregivers having at least one emergency room or hospital visit every six months, says an Indiana University study.

It’s long been recognized that family care of an Alzheimer’s patient is difficult, but the Indiana University researchers said their study is the first to actually measure the stress and examine how it affects the physical and mental health of caregivers.

The study included 153 Alzheimer’s patients and their family caregivers, for a total of 366 people. Forty-four percent of the caregivers were spouses, and 70 percent lived with their Alzheimer’s-afflicted loved one. The average age of the caregivers was 61 years.

Age, education and relationship to the patient didn’t affect caregivers’ use of emergency room/hospital services, the researchers found. The behavior and functioning of the patient, not their cognitive disability, were the major factors that determined whether a caregiver went to the emergency room/hospital.

The study was published in the November issue of the Journal of General Internal Medicine.

“Our findings opened our minds to the fact that society needs to expand the definition of patient to include both the person with Alzheimer’s dementia and that individual’s family caregiver,” study corresponding author Dr. Malaz Boustani, an assistant professor of medicine, said in an Indiana University new release.

“For American society to respond to the growing epidemic of Alzheimer’s disease, the health care system needs to re-think the definition of patient. These findings alert health-care delivery planners that they need to restructure the health care system to accommodate our new inclusive definition of patient,” said Boustani, who directs the Healthy Aging Brain Center.

About four million older adults in the United States have Alzheimer’s disease, and three million of them live in the community, often under the care of family members. By 2050, it’s estimated there will be 18.5 million people with Alzheimer’s in the U.S.

“While we’ve long known that Alzheimer’s is a devastating disease to the patient, this study offers a look at how it also impacts the caregiver’s health. If we don’t offer help and support to the caregiver too, the stress of caring for someone with dementia can be overwhelming, both mentally and physically,” Dr. Cathy C. Schubert, an assistant professor of clinical medicine in the IU School of Medicine, said in the news release.

NY Times, 11/21/08 (http://www.nytimes.com/2008/11/21/health/chen11-20.html?_r=1&partner=rss&emc=rss&pagewanted=print )

During medical school, I went to see a doctor who came highly recommended from a classmate. This doctor had not only found the cause of my friend’s pain, but she had also offered insight on how to juggle a successful medical career with a busy family life. My friend was rapturous with praise about how human this doctor was — “She’s so real” were the words I remember my friend using — and she urged me to give the doctor a try.

But my visit was not how I had imagined it would be. The doctor did help me medically, but along the way I learned about her training, her kids and her health problems. I even learned about a brewing personal issue when she let me in on some of the details before leaving the exam room to take a personal phone call. While she might have let her guard down more than usual because I was a budding physician, I wasn’t so sure she had focused on me during the exam and I felt overwhelmed by all the information she had shared.

It was, as they say, “T.M.I.,” too much information.

How much should doctors tell their patients?

Up until recently there has been little systematic research regarding physician self-disclosure and patient satisfaction. Historically, doctors erred on the side of saying little or nothing about themselves, positioning themselves as a “blank slate” against which patients could freely discuss concerns.

By the time I was in medical school in the late 1980s, those boundaries between doctors and patients had become more porous. Lecturers now told us that it was impossible to be a truly blank slate, as doctors and patients unconsciously pick up on one another’s personal cues. Eeven the most discreet doctors unintentionally reveal something during their interactions with patients. Patients might notice the kinds of shoes their doctor wears, the presence or absence of a wedding ring, and even the photographs or trinkets on his or her desk.

Some of my classmates took the idea of “no blank slates” one step further. They believed that by sharing more, by acting more “human,” doctors could strengthen the bonds with their patients.

But whatever our individual leanings were in practice, there was also very little research or evidence for young doctors to fall upon for guidance. The doctor-patient interaction was firmly part of the “art” and not the “science” of our work, so we based our ideas on anecdotal evidence, usually our own experiences. For me, the singular experience with my friend’s doctor made me less enthusiastic about disclosing my personal life to patients. And after a few more years of training, I found that I rarely brought my own life into the clinic or hospital room except when a patient specifically asked.

Over the last four years, there have been several studies on the effects of physician self-disclosure on patient satisfaction. It turns out that patients don’t always want to know about their doctors’ personal experiences. And doctors don’t always do a great job when they do choose to share their personal information.

Susan H. McDaniel and her colleagues at the University of Rochester School of Medicine and Dentistry found that doctors made self-disclosure statements in approximately a third of patient visits, but almost 40 percent of these statements were unrelated to the patient’s symptoms, family or feelings. In addition, in the vast majority of cases, doctors never returned to the topic that inspired the personal reference in the first place.

Interestingly enough, there is also a difference in how patients react to doctors from different specialties. Dr. Mary Catherine Beach and her colleagues at the Johns Hopkins School of Medicine in Baltimore found that when surgeons revealed something personal, patients were significantly more satisfied with their quality of care than when surgeons kept mum. But when primary care doctors disclosed a fact from their own lives, their patients were significantly less satisfied.

I was intrigued by these findings and called Dr. Beach.

“No, I did not expect those results,” Dr. Beach responded. “And we didn’t see a difference in what the surgeons were saying to their patients versus what the primary care doctors were saying.”

Dr. Beach offered a few possible explanations for the difference. Patients may not expect surgeons to share such personal information or may feel more vulnerable and anxious as they face the possibility of an operation. With primary care physicians, on the other hand, patients might interpret a personal disclosure like, “Don’t worry about the pain in your knee; I get that all the time, too,” not as reassuring but as dismissive or as an attempt to invalidate concerns.

As a doctor, I have often wondered if those of us who disclose little seem less “real” to our patients. At the same time, as Dr. Beach notes, there may be “a little bit of narcissism and self-centeredness going on in physician self-disclosure.” I may feel a better sense of rapport with a patient after inserting a personal note into the conversation. But at that point the focus of the discussion begins to center on me, or how I am like the patient, rather than on the patient.

When I consider my experiences as a patient, I find that my favorite doctors rarely offer their own information in the exam room. Nonetheless, I do feel a deep personal connection with them and can even reel off a few facts about their lives. But I have learned about my gynecologist and my children’s pediatrician because I have asked them specific questions during our office visits on terms that I, the patient, have set.

“Doctors should think about it before they make a self-disclosure statement,” Dr. Beach said, “because most of the time these statements occur reflexively and without much thought. Doctors should make sure the statement has some purpose in the conversation and that it is either helpful to the patient or is about empathy. And they must transfer the focus of the conversation quickly back to the patient, so they don’t run on and on about themselves.”

I asked Dr. Beach how her research affected her practice.

“I don’t spontaneously disclose as much anymore,” she answered. “As I was writing the study, I began to pay attention to my own behavior. I found that self-disclosure wasn’t really as useful as I believed it might have been.”

“Having people see your emotional commitment is not a bad thing, but self-disclosure in practice is not as effective as people think it might be in building rapport,” she said.

Audebert HJ, et al “Long-Term effects of specialized stroke care with telemedicine support in community hospitals on behalf of the Telemedical Project for Integrative Stroke Care (TEMPiS)” Stroke 2009; 40.
MedPage Today, 11/20/08 (http://www.medpagetoday.com/Neurology/Strokes/11864)

The long-term prognosis for stroke patients is better at community hospitals equipped with monitoring technology, trained multidisciplinary teams, and teleconsultation capability, researchers found.

Hospitals that implemented such stroke unit treatment in the Bavaria region of Germany significantly reduced combined death, institutional care, and disability among stroke patients by 35% at 12 months (P<0.01) and by 18% at 30 months (P=0.031) compared with other community hospitals, said Heinrich J. Audebert, M.D., of Charite Hospital here, and colleagues.

In the prospective study, the change also tended to reduce the rate of death and institutional care at 12 months (odds ratio 0.89, P=0.23) and 30 months (OR 0.93, P=0.40) after adjustment for potential confounders, the researchers reported online in Stroke: Journal of the American Heart Association.

“The set-up of stroke wards in community hospitals with appropriate facilities and education supported by telemedicine-linked academic stroke centers offers a new way to provide specialized stroke care in smaller hospitals,” the researchers concluded.

Their Telemedical Project for Integrative Stroke Care (TEMPiS) compared five hospitals that implemented the stroke intervention with another five general community hospitals in the same in region but without specialized stroke services or telemedical networking.

The intervention included establishing stroke wards with multidisciplinary stroke teams trained through continuing medical education and monitoring facilities, developing standardized treatment protocols at the centers, and providing a 24-hour teleconsultation service through two academic stroke centers.

The researchers had previously shown three-month survival and dependency advantages at hospitals that made these changes and joined the telemedicine network.

To see what the long-term effects were, the researchers studied outcomes for the 3,060 consecutive patients with ischemic or hemorrhagic stroke admitted from July 2003 through March 2005 after the stroke care system was set up.

After about two and a half years of patient follow-up, cumulative survival rates were 68.0% in the intervention group compared with 65.5% in the control group (P=0.271).

In multivariate analysis, implementation of the stroke ward and telemedicine changes significantly reduced the rate of “death and dependency” — the combined rate of death, institutional care, and disability measured as a score of more than 60 on the Barthel index or a Rankin score above 3 — at 12 months (OR 0.65, P<0.01) and 30 months (OR 0.82, P=0.031).

The intervention appeared to have its greatest effect early after stroke. The two hospital groups had the largest absolute difference in this outcome at three months (10.4% versus 9.3% at 12 months and 5.2% at 30 months).

The impact of the intervention may have been offset by an increasing impact of other factors such as age and other diseases with time, Dr. Audebert and colleagues said.

After adjustment for potential confounders, the intervention did not significantly reduce the combined rate of death and institutional care at 12 months (OR 0.89, P=0.23) and 30 months (OR 0.93, P=0.40) compared with typical community hospital care.

The researchers attributed the lack of significance to smaller absolute differences, which the study was “clearly underpowered to detect.”

Nevertheless, they said, the reduction in the likelihood of overall death or dependency at all three follow-up time points and after adjustment suggested “a long-lasting beneficial effect of specialized acute stroke care in community hospitals with continuous medical education and telemedicine consultation.”

They cautioned that the effect of the changes implemented at the community hospitals could not be attributed to telemedicine consultation alone because only 36% of admitted stroke patients at these hospitals had a teleconsult.

They pointed out that “in contrast to randomized, controlled trials that balance all observed and unobserved confounders between treatment and control groups, we cannot rule out that some unobserved differences in patient characteristics between the intervention group and the control group contributed to our results.”

As an example, they noted that the intervention might have changed the characteristics of patients admitted to these hospitals because stroke patients in some areas were preferentially sent to intervention hospitals expecting better care.

Source:  http://www.cdc.gov/ncidod/dbmd/diseaseinfo/haeminfluserob_t.htm

Haemophilus influenzae Serotype b (Hib) Disease

HealthDay, 11/20/08 (http://healthday.com/Article.asp?AID=621590)

U.S. health officials said Thursday that a shortage of vaccine is leading them to monitor Hib infections, one of the most important causes of bacterial illness in young children.

Though the agency has yet to see an increase in cases, the stepped-up surveillance was prompted by a disruption in the supply of vaccine that has virtually eliminated Hib (Haemophilus influenzae type b) infections since it was introduced in 1988.

Hib infection can cause a variety of illnesses, including meningitis (inflammation of the membranes covering the spinal column and brain), blood stream infections, and pneumonia, according to the U.S. Centers for Disease Control and Prevention. Hib is not a cause of the seasonal flu.

“The shortage is not serious but it is concerning,” said Michael Jackson, an epidemiologist with the CDC.

The shortfall was caused by a recall of certain lots of Hib conjugate vaccine, and then the suspension of production by drug maker Merck & Co. last December. Merck originally expected to resume production late this year, but delays have pushed that timetable back to the middle of 2009, the CDC said in its Nov. 21 Morbidity and Mortality Weekly Report.

One reason the vaccine shortage hasn’t been more serious is that drug maker Sanofi-Aventis also makes Hib vaccine, Jackson said.

Before the introduction of the vaccine, some 20,000 U.S. children would get serious and sometime fatal Hib infections each year, the CDC noted.

Merck spokeswoman Amy Rose said that problems with the vaccine’s sterilization process necessitated recalling the vaccine and then stopping production. The vaccines are marketed as PedvaxHIB and Comvax.

To manage the shortage, health officials are recommending giving the Hib vaccine to infants, but holding off on a recommended booster shot for children age 12 to 15 months, except those at increased risk for Hib disease.

“Right now the recommendations are to make sure all children get the primary vaccine series, and providers should defer giving the booster dose until the vaccine supply increases,” Jackson said. “We are not worried about sudden increases in Hib disease, but we are worried over time that, not having the booster, we could start to see increases in Hib,” he said.

The agency is asking doctors, state health departments and state laboratories to increase their surveillance of Hib.

Jackson said tracking Hib cases isn’t easy. There are many different types of influenzae and there are many steps involved in testing and reporting the various types, so information often gets lost along the way, he said.

“The information we are getting at CDC is that we are missing about 40 percent of cases,” Jackson said. “That’s a little worrisome because that’s 40 percent of people we don’t know if they have type b, which is the vaccine-preventable one, the one we are really worried about, or if they have something else. It makes it harder for us to see changes in Hib if there really is something going on in the population.”

Dr. Marc Siegel, an associate professor of medicine at New York University School of Medicine, said parents shouldn’t panic because of the vaccine shortage.

“There used to be 20,000 cases a year, but the vaccine has brought it to less than 100,” Siegel said. “The numbers remain small. We’ve almost stamped this thing out with the vaccine, so don’t assume your kid is going to get it.”

FDA Med Device Recall, 11/20/08

Class 1 Recall: Animas Corporation, Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump

FDA Approves New Drug to Treat Severe Form of Epilepsy, 11/20/08

The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome.

“This approval offers another treatment option for patients who suffer from these debilitating, severe seizures,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

Lennox-Gastaut syndrome is a severe form of epilepsy that usually begins before 4 years of age, and can be caused by brain malformations, severe head injury, central nervous system infection and inherited degenerative or metabolic conditions. In 30-35 percent of cases, no cause can be found. Patients may have periods of frequent seizures mixed with brief, relatively seizure-free periods; and suffer from varying types of seizures including tonic (stiffening of the body, upward deviation of the eyes, dilation of the pupils, and altered respiratory patterns), atonic (brief loss of muscle tone and consciousness, causing abrupt falls), atypical absence (staring spells), and myoclonic (sudden muscle jerks).

Most children with Lennox-Gastaut syndrome experience some degree of impaired intellectual functioning or information processing, along with developmental delays and behavioral disturbances.

In a single four-month clinical trial studying patients 4 to 30 years old, patients taking Banzel had improved seizure control when compared to those taking placebo. The observed effect was approximately a 41 percent reduction of tonic plus atonic seizure frequency over placebo and 20 percent reduction of total seizure frequency over placebo. In addition, overall improvement was reported as measured by a parent/guardian evaluation.

Common adverse reactions reported by patients using Banzel in clinical trials included headache, dizziness, fatigue, drowsiness, gait disturbance, double-vision, nausea and vomiting. Banzel’s labeling will include a warning that antiepileptic drugs increase the risk of suicidal thoughts or behaviors in patients taking the drug for any indication. Patients taking antiepileptic drugs should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and unusual changes in mood or behavior. This warning is based on the results of analyses performed by the FDA on nearly 200 controlled clinical trials with 11 FDA-approved antiepileptic drugs. Banzel was not included in these analyses, but the results are considered to apply to all chronically administered antiepileptic drugs, including Banzel. As discussed at a July 2008 public advisory committee meeting, the FDA is working with manufacturers of all antiepileptic drugs to include similar warning statements in prescribing information. The FDA is requiring that a patient Medication Guide be given to patients and caregivers when Banzel is dispensed. The Medication Guide will describe the risk of suicidal thoughts and behavior associated with the class of antiepileptic drugs.

Banzel is manufactured by Eisai Medical Research Inc., Woodcliff Lake, N.J.

Banzel was granted orphan drug designation by the FDA. A drug is eligible for orphan drug designation if it is intended to treat a disease or condition that affects fewer than 200,000 people in the United States. This designation can also be extended to drugs for diseases or conditions that affect a larger number of patients if there is no reasonable expectation that the cost of developing such medications and making them available will be recovered from sales.

FDA, 11/20/08:  Wegmans Food Markets, Inc. Issues Voluntary Recall on Wegmans Italian Classics Seasoned Tomato Sauce 

Contact:
Jo Natale
585-429-3627

FOR IMMEDIATE RELEASE — Rochester, NY — November 20, 2008 — Wegmans Food Markets, Inc. is initiating a voluntary recall of 24 oz. Wegmans Italian Classics Seasoned Tomato Sauce with a “use-by- date of 11/26/08”, UPC 77890 79010. The product is being recalled because the package may actually contain a milk ingredient which is not declared on the label. The recall of this product is of concern only to those individuals who have an allergy to milk. Consumption may cause a serious or life-threatening allergic reaction in persons with an allergy to milk.  No other code dates are affected by this recall.

The 24 oz. Wegmans Italian Classics Seasoned Tomato Sauce is packaged in a clear flexible pouch, and was sold in the prepared foods department of Wegmans stores located in New York, New Jersey, Pennsylvania, Virginia, and Maryland.

The affected product would have been available in Wegmans stores between Saturday, November 15 and Thursday, November 20. Wegmans reports that this problem is limited to 108 cases of product, and that all product with the affected code date is no longer on store shelve.

No illnesses have been reported to date. 

The problem was discovered by a Wegmans store employee. The recall was initiated after it was discovered that the affected code of Italian Classics Seasoned Tomato Sauce actually contained VODKA BLUSH SAUCE which contains milk.

Concerned customers should return the recalled product to Wegmans for a full refund.  Customers who have consumed the product and feel they are experiencing symptoms should contact their physician.  Wegmans’ customers who have questions or concerns about this recall should contact the consumer affairs department at 1-800-WEGMANS, ext. 4760.

Wegmans Food Markets, Inc. is a 72-store supermarket chain with stores in New York, Pennsylvania, New Jersey, Virginia, and Maryland. The family-owned company, founded in 1916, is recognized as an industry leader and innovator. Wegmans has been named one of the ‘100 Best Companies to Work For’ by FORTUNE magazine for eleven consecutive years. In 2008, Wegmans ranked #3 on the list.