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February 29th, 2008 posted by Paul Rega, MD, FACEP February 29, 2008 @ 8:28 am

21 deaths linked to heparin

NY Times, 2/29/08: 

Amid indications that more people may have died or been harmed after being given a brand of the blood thinner heparin, federal drug regulators said Thursday that they had found “potential deficiencies” at a Chinese plant that supplied much of the active ingredient for the drug.

Baxter International, which makes the brand of heparin associated with the problems, and buys supplies from the Chinese plant, announced that it was expanding a recall to include virtually all its heparin products. Though Baxter produces much of the heparin used in the United States, regulators said the other major supplier would be able to meet the demand.

The Food and Drug Administration said the number of deaths possibly associated with the drug, made from pig intestines, had risen to 21 from 4. But it cautioned that many of those patients were already seriously ill and that the drug might not have caused their deaths.

The F.D.A. emphasized that it had yet to identify the root cause of the problem, and that it had not concluded that the Chinese plant was responsible. The agency also said it was investigating two Chinese wholesalers — also called consolidators — that supplied crude heparin to the Chinese plant, Changzhou SPL, as well as those that sold raw ingredients to the consolidators.

The New York Times reported Thursday that at least one of the consolidators received supplies from small, unregulated family workshops that scraped mucous membrane from pig intestines and cooked it, eventually producing a dry substance known as crude heparin.

The F.D.A. admitted this month that it had violated its own policy by failing to inspect SPL, located west of Shanghai, before the factory began shipping the heparin ingredient to Baxter in 2004. China’s drug agency also did not inspect the plant.

Last week, the F.D.A. sent inspectors to the plant. Among the potential problems they found was a failure to properly follow the steps for identifying impurities and deficiencies related to manufacturing equipment. According to a redacted inspection report released by the agency, the SPL plant appeared to have made at least some heparin with “material from an unacceptable workshop vendor.” The vendor was not identified.

Scientific Protein Laboratories, a Wisconsin company that is the majority owner of the Chinese plant, issued a statement Thursday saying the F.D.A.’s finding did not represent its final determination as to whether the plant complied with federal regulatory rules. S.P.L., the statement said, is committed to finding the root cause of the adverse reactions.

Erin Gardiner, a spokeswoman for Baxter, said the company was reviewing the F.D.A.’s report. “We expect S.P.L. to respond to those observations thoroughly and promptly,” Ms. Gardiner said. “The observations are important and need to be addressed promptly but they are not necessarily indicative of the root cause.”

The F.D.A.’s concern about heparin had previously centered on Baxter’s multidose vials, but on Thursday Baxter agreed to voluntarily recall not only the multi-dose vials but also single-dose vials and a diluted solution of heparin used to keep blood clots from forming in intravenous lines. There have been no adverse reaction reports involving the latter product, called Hep-Lock heparin flush products.

“We have assurance from the U.S. Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs,” Peter J. Arduini, president of Baxter’s Medication Delivery business, said in a statement released by the company.

The only heparin products made by Baxter that are still on the market are premixed bags of intravenous solutions, the Food and Drug Administration said.

“We at the F.D.A. understand how unsettling this whole situation with heparin is,” said Dr. Sandra Kweder, the agency’s deputy director, Office of New Drugs, Center for Drug Evaluation and Research. “We are determined to get to the root cause.”

The F.D.A. estimates that more than one million multidose vials of heparin are sold per month in the United States, about half of which are manufactured and distributed by Baxter.

The problems with heparin, which is used to prevent blood clotting during dialysis and after some surgery, were first reported last month at a hospital in Missouri. Since then, the number of reported adverse reactions has risen to 448, the F.D.A. said. “Yes, we have gotten more and we are continuing to evaluate those reports,” Dr. Kweder said.

At first, the agency said it believed that four people had died after allergic reactions to the drug. On Thursday, officials said as many as 17 more people may have died, but they described the links to heparin as more tenuous.

The adverse reactions have included decreased or low blood pressure and fast heart rate. Not all of them are known to involve Baxter products, but the drug agency did not issue warnings involving any other products.

The Chinese heparin market has been in turmoil over the last year, as pig disease has swept through the country, depleting stocks, leading some farmers to sell sick pigs into the market and forcing heparin producers to scramble for new sources of raw material.

As a result, even big companies have been turning increasingly to small village workshops, which are often unsanitary. In interviews this week at some of these workshops, employees told The Times that they had not been inspected by the government.

Scientific Protein Laboratories said it responded to the disease outbreak by buying less raw material in China. Its president, David Strunce, said in an interview this week that the Chinese plant bought supplies only from two reputable consolidators, and that its suppliers were audited.

The F.D.A has already finished inspecting one of the consolidators and is still looking at the second one, an agency spokeswoman said. The agency also plans, if necessary, to look at some of the small workshops that supply the consolidators.

“We will go where the investigation takes us,” an agency official said.



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February 29th, 2008 posted by Paul Rega, MD, FACEP @ 8:21 am

Interpol on alert forsuspected terrorist

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AP, 2/29/08:  Interpol said Friday it has issued a worldwide security alert following the escape of an alleged Islamic terror leader from a jail in Singapore.

art.mas.selamat.ap.jpg Mas Selamat Kastari.

The international police organization said it put out an “Orange Notice” on Mas Selamat Kastari, who slipped away from a detention center in Singapore Wednesday.

Mas Selamat is accused of plotting to hijack a plane and crash it into Singapore’s international airport.

The Interpol notice, which includes Mas Selamat’s photograph and fingerprints, was issued following a request by Singapore, the agency said in a statement on its Web site.



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February 29th, 2008 posted by Paul Rega, MD, FACEP @ 8:07 am

“Goodbye, Ali” with Apologies to Carol Channing

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CNN, 2/29/08:  The Iraqi presidency has approved the execution of Ali Hassan
al-Majeed who earned the nickname “Chemical Ali” for his role in
a chemical weapons attack on on Iraqi Kurds in the 1980s. A
court convicted al-Majeed — a cousin of Saddam Hussein — for
his role in a series of attacks that killed at least 100,000
Iraqi Kurds in the 1980s.

Sung to the tune of “Hello, Dolly:”

1

“Well goodbye, Ali

You’re gonna die, Ali

It’s so nice to have you leave us very soon.

You’re a slug, Ali

No better than a bug, Ali

You’ll be crapping as your neck is snapping,

It’s so jejune…!”

1
 



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February 29th, 2008 posted by Paul Rega, MD, FACEP @ 7:51 am

Earthquake: On this day in disaster history…

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1960, Agadir, Morocco: Thousands dead in Moroccan earthquake.  People, including several children, continued to be pulled alive from under the rubble for up to 12 days following the disaster. The final death toll was 12,000.

BBC, 1960:  A huge earthquake has devastated the southern Moroccan city of Agadir killing thousands.

1  Agadir then.

A major operation is now underway to rescue scores of people, including many tourists, still trapped under the rubble.

Most of the “new town” area of Agadir has been completely destroyed and the heavily populated Talborit quarter is believed to have been the hardest hit.

Agadir now.1

The number of dead currently stands at more than 1,000 although some have suggested the toll could rise to as many as 20,000.

The earthquake, which measured 6.7 on the Richter scale, hit the city at 2339 hrs (local time) tonight.

Cries for help

It lasted for more than 10 seconds and was accompanied by a massive tidal wave which added to the destruction. Fire broke out across the city soon afterwards.

Eye-witnesses report hearing screams and cries for help from those trapped.

A British tourist, staying in one of the city’s luxury hotels, told the Times newspaper: “It was very frightening, and within a few moments masonry was dropping all around us.

“The lights went out and there was complete darkness. For a moment we just sat, not knowing what was happening.”

Another said: “I was reading in bed in my room at my hotel when the earthquake came.

“The room seemed to swirl around and then the ceiling collapsed and the walls caved in.”

Rescue teams have been drafted in from Morocco’s main regions and from cities around the world.

Agadir’s airport, which was undamaged, has been set up as a temporary hospital for the injured. Many wounded were flown to Casablanca during the night.

Among the buildings reduced to a pile of rubble were the city’s hospital, the newly-constructed luxury Saada hotel and The National Militia headquarters.



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February 29th, 2008 posted by Paul Rega, MD, FACEP @ 7:22 am

MMWR: Perceived Insufficient Rest or Sleep

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MMWR, Chronic sleep loss is an under-recognized public health problem that has a cumulative effect on physical and mental health. Sleep loss and sleep disorders can reduce quality of life and productivity, increase use of health-care services, and result in injuries, illness, or deaths (1).

1 

Epidemiologic surveys suggest that mean sleep duration among U.S. adults has decreased during the past two decades (CDC, unpublished data, 2007). An estimated 50–70 million persons in the United States have chronic sleep and wakefulness disorders (1). Most sleep disorders are marked by difficulty falling or staying asleep, daytime sleepiness, sleep-disordered breathing, or abnormal movements, behaviors, or sensations during sleep (1). To examine characteristics of men and women who reported days of perceived insufficient rest or sleep during the preceding 30 days, CDC analyzed 2006 Behavioral Risk Factor Surveillance System (BRFSS) data from four states (Delaware, Hawaii, New York, and Rhode Island). This report summarizes the results of that analysis. Among all respondents, 29.6% reported no days of insufficient rest or sleep during the preceding 30 days and 10.1% reported insufficient rest or sleep every day during the preceding 30 days. Rest and sleep insufficiency can be assessed in general medical-care visits and treated through effective behavioral and pharmacologic methods. Expanded and more detailed surveillance of insufficient rest or sleep (e.g., national estimates) might clarify the nature of this problem and its effect on the health of the U.S. population.

BRFSS is a state-based, random-digit–dialed telephone survey of the noninstitutionalized, U.S. civilian population aged >18 years, conducted by state health departments in collaboration with CDC (3). The median response rate (i.e., the percentage of persons who completed interviews among all BRFSS-eligible persons, including those who were not successfully contacted) among the four states asking the sleep question in 2006 was 46.6% (range: 41.0%–48.6%). The median cooperation rate (i.e., the proportion of all respondents interviewed among those contacted) for the four states was 72.2% (range: 65.0%–73.3%). The median response rate among all states in the 2006 BRFSS was 51.4% (range: 35.1%–66.0%).

In 2006, the question “During the past 30 days, for about how many days have you felt you did not get enough rest or sleep?” was asked in the four states. Data from the four states were combined, and the number of days of perceived insufficient rest or sleep (0 days, 1–6 days, 7–13 days, 14–20 days, 21–29 days, and 30 days) was categorized. Analyses were stratified by race/ethnicity, age group, sex, education level, and employment status. Weighted prevalence estimates and 95% confidence intervals (CIs) were calculated using statistical software to account for the complex survey design.* Differences with nonoverlapping CIs were considered statistically significant.

In 2006, 29.6% of respondents in the four states reported no days of insufficient rest or sleep during the preceding 30 days (Table). In Hawaii, 38.4% of respondents indicated no days of rest or sleep insufficiency during the preceding 30 days, which was significantly greater than the 27.7% of respondents in Delaware, 29.2% in New York, and 27.7% in Rhode Island. Responses categorized by race/ethnicity and sex were not significantly different. The prevalence of no days of insufficient rest or sleep increased with age; 44.7% of persons aged >55 years reported no days of insufficient rest or sleep, compared with 21.9% of persons aged 18–34 years. Retired persons (53.5%) were significantly more likely to report no days of insufficient rest or sleep than persons who were employed (24.0%), unemployed (32.9%), unable to work (24.6%), or otherwise employed (28.1%). Finally, as education level increased, a smaller percentage of respondents reported no days of insufficient rest or sleep: 39.7% of adults with less than a high school diploma or General Educational Development certificate (GED) reported no days of insufficient rest or sleep, compared with 33.4% of those with a high school diploma or a GED and 26.3% of those with some college or a college degree.

On average, 10.1% of respondents reported insufficient rest or sleep every day during the preceding 30 days. Persons aged >55 years (7.3%) were significantly less likely to report 30 days of insufficient rest or sleep, compared with persons aged 18–34 years. Similarly, retired persons (5.5%) were significantly less likely to report 30 days of insufficient rest or sleep. Persons who were unable to work (24.8%) were significantly more likely to report 30 days of insufficient rest or sleep than employed (9.9%), unemployed (12.8%), or otherwise employed persons (10.6%).

Reported by: LR McKnight-Eily, PhD, LR Presley-Cantrell, PhD, TW Strine, MPH, DP Chapman, PhD, GS Perry, DrPH, JB Croft, PhD, Div of Adult and Community Health, National Center for Chronic Disease Prevention and Health Promotion, CDC.

Editorial Note:

 

This report is one of the first to present state-level information on any sleep-related measure. The findings indicate that 29.6% of adult respondents in the four states reported no days of insufficient rest or sleep during the preceding 30 days, whereas 10.1% reported insufficient rest or sleep every day. Responses to this survey did not vary significantly when categorized by sex or race/ethnicity, possibly because of the limited sample size of minority populations in some of the four states. Previous studies have indicated disparities in the prevalence of sleep-related problems in minority populations (2) and in women (4). Although certain studies have indicated that sleep disturbance is more prevalent among older adults, the results from the study described in this report are consistent with research indicating that older adults (who are more likely to be retired) are less likely to report impaired sleep (4). Persons unable to work expressed the greatest prevalence of perceived rest or sleep insufficiency, which might be the result of mental distress or the medical problems, disabilities, or other conditions that prevent them from being employed (5).

Geographic variation in reported rest or sleep insufficiency among the four states described in this report might result from local and cultural differences, including variations in opportunities for shift work. The causes of perceived rest or sleep loss might include occupational factors such as extended work schedules, jet lag, or shift work, resulting in irregular sleep schedules (1). Lifestyle choices, including late-night television watching, Internet use, or consumption of caffeine and other stimulants (i.e., alcohol and over-the-counter or prescribed medications), also can result in sleep loss (1). Additionally, common sleep disorders such as insomnia, sleep-disordered breathing, sleep apnea, restless legs syndrome, narcolepsy, and circadian rhythm disorders, can cause sleep loss (1). Sleep disorders and sleep loss are associated with mental distress, depression, anxiety, obesity, hypertension, diabetes, high cholesterol, and adverse health behaviors such as cigarette smoking, physical inactivity, and heavy drinking (1,4,6).

The findings in this report are subject to at least four limitations. First, the definitions of “enough” (sufficient) sleep and “rest” and responses to the survey question were subjective and were not accompanied by reports of hours of sleep per night; therefore, this analysis cannot be compared directly with studies measuring hours of sleep. Because the survey question also did not define or distinguish between “rest” and “sleep,” respondents might vary in their interpretation of the questions and the terms. Second, causes of rest or sleep insufficiency were not ascertained by the survey. The BRFSS question does not allow for estimates of the prevalence or incidence of specific sleep disorders in the population. Third, persons with severely impaired mental or physical health might not be able to complete the BRFSS, and institutionalized persons, and persons residing in households without landline telephones are not included in the survey. For those reasons, and because the analysis was limited to data from the four states that asked the rest or sleep insufficiency question, results might not be representative of the entire United States. Finally, the median response rate of 46.6% was low. However, BRFSS data have minimal bias compared with census data (3).

According to a 2005 National Sleep Foundation poll, U.S. adults sleep an average of 6.9 hours per night, and 40% report sleeping less than 7 hours on weekdays (7). The National Sleep Foundation reports that most adults need 7–9 hours of sleep each night to feel fully rested, children aged 5–12 years require 9–11 hours, and adolescents require 8.5–9.5 hours each night.§ Few formal clinical practice guidelines or practice parameters are yet available for assessing and treating rest or sleep insufficiency and sleeping disorders (2,8). Further research and randomized clinical trials are needed to establish the efficacy of several treatment modalities available (1).

Persons concerned about chronic rest or sleep insufficiency should seek evaluation and treatment by a physician, preferably one familiar with assessment and treatment of these conditions (1). Clinicians should advise patients who need to improve their sleep quality to keep a regular sleep schedule; sleep in a dark, quiet, well-ventilated space with a comfortable temperature; avoid stimulating activities within 2 hours of bedtime; avoid caffeine, nicotine, and alcohol in the evening; and avoid going to bed on a full or empty stomach.

Acknowledgment

The findings in this report are based, in part, on data provided by BRFSS state coordinators from Delaware, Hawaii, New York, and Rhode Island.

References

 

  1. Institute of Medicine. Sleep disorders and sleep deprivation: an unmet public health problem. Washington, DC: The National Academies Press; 2006. Available at http://www.iom.edu/cms/3740/23160/33668.aspx.
  2. US Department of Health and Human Services, National Center on Sleep Disorders Research. 2003 National Sleep Disorders Research Plan. Available at http://www.nhlbi.nih.gov/health/prof/sleep/res_plan/sleep-rplan.pdf.
  3. CDC. Public health surveillance for behavioral risk factors in a changing environment: recommendations from the Behavioral Risk Factor Surveillance Team. MMWR 2003;52(No. RR-9).
  4. Strine TW, Chapman DP. Associations of frequent sleep insufficiency with health-related quality of life and health behaviors. Sleep Med 2005;6:23–7.
  5. Roth T. Prevalence, associated risks, and treatment patterns of insomnia. J Clin Psychiatry 2005;66(Suppl 9).
  6. Newman AB, Nieto FJ, Guidry U, et al. Relation of sleep-disordered breathing to cardiovascular disease risk factors: the sleep heart health study. Am J Epidemiol 2001;154:50–9.
  7. National Sleep Foundation. 2005. Sleep in America poll: summary of findings. Available at
    http://www.kintera.org/atf/cf/%7bf6bf2668-a1b4-4fe8-8d1a-a5d39340d9cb%7d/2005_summary_of_findings.pdf.
  8. American Academy of Pediatrics. Clinical practice guideline: diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics 2002;109:704–12.


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February 29th, 2008 posted by Paul Rega, MD, FACEP @ 7:13 am

MMWR: Human Rabies

 

MMWR, February 29, 2008 / 57(08);197-200:

On April 26, 2007, a patient from Alberta, Canada, died after 9 weeks in an intensive care unit (ICU) from encephalitis caused by a rabies virus variant associated with silver-haired bats. This report summarizes the clinical course of disease in that patient, who was treated using the Milwaukee Protocol, an experimental treatment protocol similar to one used for the rabies survivor described in 2005 (1). This report also describes the subsequent epidemiologic investigations by three regional public health departments in Alberta. Rabies continues to be a cause of human death in the developed and developing world. The findings in this report underscore the need for continued public education that promotes rabies prevention and postexposure prophylaxis while emphasizing the importance of bat exposure in rabies transmission.

Case Report

 

During August 2006, a man aged 73 years was bitten by a bat on his left shoulder while sleeping at home in rural Alberta. He killed and disposed of the bat and did not seek medical attention. The patient had no history of previous rabies vaccination and became ill on February 14, 2007, when he had onset of left shoulder pain. The pain was radicular, severe, and progressive and evolved to include left hand weakness during the next few days. The man sought care at a local emergency department on February 15, 17, and 19, and was administered analgesics.

On February 21 (the seventh day of clinical illness), the patient was admitted to the local hospital with general weakness, anorexia, and dysphagia. His family described the patient as irritable and not himself. Forty-eight hours after admission, the patient had left arm myoclonus and gasping respirations, suggestive of inspiratory spasms. His illness progressed with high fever, hypoxia, hypersalivation, and a decreased level of consciousness. He required intubation and was transferred to a tertiary-care hospital ICU on February 23 (the ninth day of clinical illness) with a presumptive diagnosis of aspiration pneumonia and sepsis. The history of a previous bat bite was not obtained at that time.

A computerized tomography scan of the head on admission to the tertiary-care hospital was unremarkable. A lumbar puncture was performed, and analysis of cerebrospinal fluid (CSF) indicated no white blood cells, normal glucose, and marginally elevated protein. A chest radiograph revealed a right lower lobe infiltrate, and treatment for presumed pneumonia with broad-spectrum antibiotics was initiated. The patient continued to deteriorate with cardiac dysrhythmias, profound hemodynamic lability, opisthotonic posturing, hypersalivation, and diffuse spasticity. Because of this evolution of the patient’s symptoms, rabies was considered as a possible diagnosis on February 26 (the 12th day of clinical illness). When asked about bites or other exposures, the patient’s family recalled that the patient had been bitten by a bat approximately 6 months before.

A nuchal biopsy specimen and saliva sample were sent to the Canadian Food Inspection Agency in Ottawa, Ontario, where the rabies diagnosis was confirmed on March 1 (the 15th day of clinical illness). Presence of viral antigen and viral RNA was detected by direct fluorescent antibody test (DFA) and reverse transcription polymerase chain reaction (RT-PCR), respectively. Subsequently, the rabies virus RNA was typed as a variant associated with silver-haired bats (Lasionycteris noctivagans).

Rabies immune globulin was administered (1,200 units intramuscularly) on March 1. After discussion with the family regarding the diagnosis, the poor prognosis, and possible management strategies, a decision was made to initiate the Milwaukee Protocol, a recently described experimental therapy for rabies (1). This regimen involves 1) induction of therapeutic coma, 2) waiting for an adaptive immune response to evolve and neutralize and clear virus from the central nervous system and periphery, and 3) supportive antiviral and metabolic therapies. In 2004, this protocol resulted in survival and good neurologic outcome for an unvaccinated female patient aged 14 years in Milwaukee, Wisconsin (1). On March 2 (the 16th day of clinical illness), the treating physicians initiated the Milwaukee Protocol, including parenteral ketamine infusion (2 mg/kg), midazolam infusion (0–20 mg/hour), ribavirin (560 µg every 8 hours), and amantadine (200 mg once daily); the protocol was modified to include L-arginine (35 g every 24 hours), enteral administration of tetrahydrobiopterin (150 mg every 8 hours), and vitamin C (500 mg once daily) to supplement possible deficiencies and to improve cerebral blood flow autoregulation. The immunologic response and peripheral viral clearance were monitored via detection of viral RNA in saliva by quantitative RT-PCR and titration of rabies virus neutralizing antibodies in sera and CSF using a rapid fluorescent focus inhibition test.

The patient’s severe hemodynamic lability improved gradually on ventilatory and low-dose pressor support. Rabies immunoglobulin G (IgG) and immunoglobulin M (IgM) were detected in serum on March 6 and in CSF on March 11, a total of 20 and 25 days, respectively, after onset of neurologic symptoms. Baseline serum and CSF tested negative for the presence of IgM and IgG against rabies virus, and subsequent development of an IgM response was thought to represent an immune response to the infection. The patient was weaned from sedation and, on April 1 (the 46th day of clinical illness), sedation was removed completely. However, no neurologic recovery occurred despite detection of low titers of virus-neutralizing antibodies (0.46–1.16 IU/mL) in CSF and normal cerebral perfusion.

Levels of virus-neutralizing antibodies in serum increased slowly and reached 0.9 IU/mL on April 24 (the 69th day of clinical illness). During the disease course, detectable rabies virus decreased markedly in the peripheral tissues, with a negative DFA on the skin biopsy and a small amount of viral RNA detected by PCR in saliva. During the same period, the patient had cardiac arrhythmias, autonomic instability, syndrome of inappropriate antidiuretic hormone secretion, hemolysis attributed to ribavirin, and ventilator-associated pneumonia.

A nuclear medicine brain death scintigraphy study revealed preserved brain perfusion; however, on April 23 (the 68th day of clinical illness), repeated magnetic resonance imaging demonstrated diffuse severe signal abnormality of the cortex, white matter, basal ganglia, and thalami. Clinical examination, including apnea testing, was consistent with brain death. After discussion with the family, life-support was withdrawn on April 26, approximately 8 weeks after initiating therapy, and the patient died. DFA staining of the autopsied brain stem and cerebral cortex demonstrated an abundance of rabies viral inclusions. These results were confirmed by RT-PCR. Microscopic examination revealed extensive and virtually complete loss of cortical neurons, whereas the cerebellum and brainstem had preservation of neurons.

Public Health Investigation

 

In conjunction with the admitting tertiary-care hospital, the public health departments of three Alberta health regions traced the household and health-care–associated contacts of the patient starting from 1 week before onset of neurologic symptoms, a practice consistent with previous similar investigations (2). Postexposure prophylaxis (PEP) was recommended for health-care workers and close contacts of the patient with a possible exposure (defined as a bite, scratch, or exposure of nonintact skin or mucous membrane surface to saliva, CSF, tears, or brain tissue). A total of 19 contacts received PEP. All family members (the patient’s wife and his two sons) were administered PEP with rabies immune globulin and vaccine. Sixteen health-care workers, who had reported exposures of mucous membranes or nonintact skin to the patient’s saliva, were administered PEP; 15 (six from the primary referring hospital and nine from the tertiary-care hospital) received rabies immune globulin and vaccine. One health-care worker, who had been vaccinated previously, received 2 booster vaccine doses. To date, none of the persons who received PEP have demonstrated illness consistent with rabies.

Reported by: J Johnstone, MD, L Saxinger, MD, Infectious Diseases, R McDermid, MD, S Bagshaw, MD, Critical Care, L Resch, MD, Pathology, Univ of Alberta; B Lee, MD, Alberta Provincial Public Health Laboratory; M Johnson, MD, Public Health Div, AM Joffe, MD, Occupational Health, Safety, and Wellness, Capital Health Region, Edmonton; G Benade, MD, Public Health Div, East Central Health Region, Camrose; D Johnson, MD, Public Health Div, Aspen Health Region, Westlock, Alberta; S Nadin-Davis, PhD, Canadian Food Inspection Agency, Ottawa; E Cheung, Public Health Laboratories Br, Ministry of Health and Long-Term Care, Etobicoke, Ontario, Canada. R Willoughby Jr, MD, Medical College of Wisconsin, Milwaukee, Wisconsin. R Franka, DVM, PhD, Div of Viral and Rickettsial Diseases, National Center for Zoonotic, Vector-Borne, and Enteric Diseases, CDC.

Editorial Note:

 

In Canada, 24 documented human rabies cases, including the one described in this report, have occurred since 1924 (2,3). Since 1970, six of the seven cases have been attributable to rabies virus variants associated with bats (2,3). Bats are an increasingly common source of human rabies in the United States, accounting for 37 (92.5%) of the 40 indigenous cases of rabies since 1990 (4). Passive surveillance of bats in western Canada during 1985–1989 indicated that 4.8% of bats submitted for testing were positive for the presence of rabies virus; the prevalence has remained stable since 1965 (5). The rabies virus variant associated with L. noctivagans bats in North America has been implicated in multiple indigenously acquired human rabies cases in the United States in recent years and also was responsible for a case of human rabies in Quebec, Canada, in 2000 (6).

After an exposure, human rabies is preventable by local wound care and administration of PEP (3,7,8). Patients with no previous rabies vaccination require rabies immune globulin and a 5-dose series of rabies vaccine (7,8). However, as the case in this report illustrates, persons are not always aware of the importance of seeking attention and PEP after bat exposures. In addition, clinicians need to recognize that a majority of patients with human rabies transmitted by bats might have no recollection of a bat bite. Thus, PEP should be considered in circumstances in which the likelihood of a bite cannot be reasonably excluded (7,8). PEP can be administered any time after an exposure, up to the onset of neurologic illness, but effectiveness of prophylaxis decreases with time; therefore, early administration of PEP is critical. After infection, the usual incubation period for rabies is 20 to 60 days, although it can vary from several days to years (8).

Only one unvaccinated rabid patient (the girl in the Milwaukee case) has survived. Several other attempts to use the Milwaukee Protocol have been unsuccessful (9). Compared with the Milwaukee patient, the patient in this report 1) had advanced age; 2) had encephalitic disease with high levels of viral load in saliva and no detectable antibody response at the time of diagnosis; and 3) had received rabies immune globulin. Immune globulin administration during clinical rabies has not been demonstrated to be useful and is not part of the Milwaukee Protocol because of concerns that it might alter the kinetics of the immune response (10).

Sixteen health-care workers received PEP after the public health investigation. The indication for PEP includes exposure of nonintact skin or mucous membranes to potentially infectious body fluids (e.g., saliva) or neuronal tissue; standard infection-control precautions can minimize health-care workers’ risk for exposure to rabies virus (7,8). To date, no cases of transmission of rabies to persons exposed through health-care activities have been documented.

This report underscores the need for increasing public awareness of the risk for rabies after contact with bats. Underestimation of the importance of such exposures can lead to a fatal outcome. Persons bitten by a bat should immediately 1) wash the wound thoroughly with soap and water; 2) capture the animal, if this can be done safely (otherwise call local animal-control services for assistance), and submit the bat for testing; 3) report the incident to local or regional/state public health officials; and 4) visit a physician for treatment and evaluation regarding the need for PEP. Timely submission of the bat (or other possibly rabid animal) to public health officials facilitates testing for the presence of rabies virus, helps to ensure rapid administration of PEP when indicated, and minimizes the unnecessary use of PEP if the animal is not rabid.

An experimental approach to treat rabies in humans requires early diagnosis. Therefore, rabies should be included in the differential diagnosis of any unexplained acute, rapidly progressive viral encephalitis.

Rabies is a fatal but easily preventable disease that has no established effective therapy after onset of clinical disease. In addition to animal vaccination, continued public education regarding rabies exposure and timely and appropriate prophylaxis is a primary strategy for human rabies prevention.

Acknowledgments

This report is based, in part, on contributions by staff members in the Capital and Aspen Health Regions, B Aitken, East Central Health Region, Alberta; F Muldoon, M Sheen, C Fehlner-Gardiner, A Wandeler, Canadian Food Inspection Agency, Ottawa, M Shaw, T Okura, R Kandiah, Public Health Laboratories Br, Ministry of Health and Long-Term Care, Etobicoke, Ontario; and CE Rupprecht, VMD, PhD, LA Orciari, MS, M Niezgoda, MS, A Velasco-Villa, PhD, PA Yager, I Kuzmin, MD, Div of Viral and Rickettsial Diseases, National Center for Zoonotic, Vector-Borne, and Enteric Diseases, CDC.

References

 

  1. Willoughby RE, Tieves KS, Hoffman GM, et al. Survival after treatment of rabies with induction of coma. N Engl J Med 2005;352: 2508–14.
  2. Parker R, McKay D, Hawes C, et al. Human rabies, British Columbia—January 2003. Can Commun Dis Rep 2003;29:137–8.
  3. Varughese P. Human rabies in Canada—1924–2000. Can Commun Dis Rep 2000;26:210–1.
  4. Blanton JD, Hanlon CA, Rupprecht CE. Rabies surveillance in the United States during 2006. J Am Vet Med Assoc 2007;231:540–56.
  5. Prins B, Loewen KG. Rabies diagnosis in western Canada, 1985–1989. Can Vet J 1991;32:487–91.
  6. Turgeron N, Tucci M, Deshaies D, et al. Human rabies in Montreal, Quebec—October 2000. Can Commun Dis Rep 2000;26:209–10.
  7. CDC. Human rabies prevention—United States, 1999: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1999;48(No. RR-1).
  8. Public Health Agency of Canada. Canadian immunization guide. 7th ed. Ottawa, Ontario: Public Health Agency of Canada; 2006:285–6. Available at http://www.phac-aspc.gc.ca/publicat/cig-gci/pdf/cig-gci-2006_e.pdf.
  9. CDC. Human rabies—Indiana and California, 2006. MMWR 2007;56:361–5.
  10. Jackson AC. Human disease. In: Jackson AC, Wunner WH, eds. Rabies. 2nd ed. San Diego, CA: Academic Press; 2007:309–40.


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February 29th, 2008 posted by Paul Rega, MD, FACEP @ 7:08 am

Hepatitis B, C and HIV Alert

ProMEDmail, 2/28/08:  The Southern Nevada Health District is advising patients who received
injected anesthesia medication at the Endoscopy Center of Nevada   (700
Shadow Lane) of a risk for possible exposure to hepatitis C and other
bloodborne pathogens.

1 

Hepatitis B

The health district is recommending that
patients who had procedures requiring injected anesthesia at the
clinic between March 2004 and 11 Jan 2008 contact their primary care
physicians or health care providers to get tested for hepatitis C as
well as hepatitis B and HIV.

The health district received notification of 3 acute cases of
hepatitis C in January 2008 and has identified a total of 6 cases to
date; 5 of the cases had procedures requiring injected anesthesia
on the same day. Following a joint investigation with the Nevada
State Bureau of Licensure and Certification (BLC) and with
consultation from the Centers for Disease Control and Prevention, the
health district determined that unsafe injection practices related to
the administration of anesthesia medication might have exposed
patients to the blood of other patients. The exposures did not result
from the [other] medical procedures performed.

1  Hepatitis C Liver

The cluster of illnesses came to the attention of the health district
in January 2008. These cases were reported to the health district by
area physicians. Nevada law requires that medical providers notify
public health officials when they identify a number of different
diseases, including hepatitis C. The common link between cases was
identified through the routine investigation of the cases reported by
medical providers, which includes an interview of the patient. Most
people infected with hepatitis C virus do not develop symptoms and do
not know that they have been infected. As a result, these infections
would not have been reported to the health district. An infection
with hepatitis C that results in the patient developing symptoms
(acute disease) is rare, so it is an unusual occurrence that brought
this problem to the attention of the health district. On average, 2
cases of acute hepatitis C are reported each year in Clark County;
6 cases have been identified in relation to this investigation.

A syringe (not a needle) that was used to administer medication to a
patient was reused on the same patient to draw up additional
medication. The process of redrawing medication using the same
syringe could have contaminated the vial from which the medicine was
drawn with the blood of the patient. The vial, which was not labeled
for use on multiple patients, was then used for a 2nd patient (with a
clean needle and syringe). If that vial was contaminated with the
blood of the 1st patient, any subsequent patients given medication
from that vial could have been exposed to bloodborne pathogens. [At
this point in the original text, the process of contamination is
illustrated by downloadable diagram. - Mod.CP]

Of the 6 known cases, 5 had procedures on the same day. Genetic
testing on 4 of the cases from that day has identified they likely
came from a common source. The patient that had a procedure on a
different day does not share a common source as the other 4. This
indicates that the problem that allowed disease transmission to occur
was not a one-time event but had recurred over an extended period.
Investigation of the clinic practices identified common practices
that would allow disease to be transmitted in this manner.

The unsafe injection practices associated with these cases were
identified during the investigation conducted in mid-January 2008.
The injection practices that led to the exposure have been
corrected, so no new patient exposures should be occurring. As it can
take several months for the symptoms of hepatitis C to appear,
additional cases might be identified despite no ongoing transmission
of disease. The investigation revealed practices that could have
exposed patients to the blood of another patient.

Although hepatitis C was the focus of the investigation, hepatitis B
and HIV can be transmitted in the same manner. It is unknown how many
people were infected at the clinic. Hepatitis C, B and HIV are
routinely found in the population. A significant number of people
might have been infected prior to their procedure. Although testing
can determine whether a person is infected, it cannot determine the
source of the infection.

Hepatitis C, B or HIV can result in a range of disease severity and
can eventually result in death. It is important that patients speak
with a physician or health care provider if they have one of these
diseases. A physician will be able to address specific risks for
serious illness and develop a plan to monitor patients’ health.

On average, 2 cases of acute hepatitis C are identified each year in
Clark County. Most people who become infected with hepatitis C
initially have mild or no symptoms and do not know that they have
been infected unless they are tested by a doctor. Only a small
percentage of people infected with hepatitis C develop acute disease
and have any outward signs of infection.

The Southern Nevada Health District is responsible for investigating
reports of illness in our community in order to take steps to protect
the health and well-being of the public. Once notified of a
reportable disease, the health district begins an investigation and
works with the appropriate agencies to address any issues identified
and make recommendations to help prevent this type of situation from
occurring again.

When proper injection practices are followed, medical procedures,
including colonoscopies or similar procedures, are generally safe.
All health care professionals and medical facilities should follow
safe injection practices and infection control procedures. Patients
can and should ask their medical providers about the practices used
in their facility.



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February 29th, 2008 posted by Paul Rega, MD, FACEP @ 6:58 am

Baxter recalls all heparin products

Intro:  No problem apparently.  FDA has concluded that there are enough supply and suppliers to make up the loss. 

FDA Press Release, 2/28/08:  Baxter International Inc. announced today that the company is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.

1

The company initially recalled nine lots of heparin sodium injection multi-dose vials on January 17, 2008 as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product and suspended production earlier this month.

Given the widespread use of this blood thinner and the impact a product shortage would have on operating rooms, dialysis centers and other critical care areas, the FDA and Baxter concluded that removing additional lots and doses of Baxter’s heparin from the market earlier would have created more risk to patients requiring heparin therapy than the increased potential for experiencing an adverse reaction. Accordingly, the FDA and Baxter decided not to recall all Baxter heparin vial products at that time. The FDA has now concluded that there is sufficient capacity on the part of other suppliers that Baxter’s recall will not jeopardize access to this drug, and has told Baxter that the company can now proceed with recalling its remaining heparin sodium injection and heparin flush products.

Although the vast majority of the reports of adverse reactions have been associated with the multi-dose products, Baxter is taking the precautionary step of recalling all remaining heparin sodium injection and heparin flush products that are currently on the market. In addition to the previously recalled lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials, Baxter’s recall will now include the remaining lots of those products and heparin sodium injection 5000 units/mL 10mL multi-dose vials, heparin sodium injection 10,000 units/mL 4mL multi-dose vials, heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and 10,000 USP units/mL single-dose vials, and all HEP-LOCK and HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative-free.

This recall does not involve Baxter’s heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.

“We have assurance from the U.S. Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs,” said Peter J. Arduini, president of Baxter’s Medication Delivery business. “The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue.”

Nearly all reported adverse reactions have occurred in three specific areas of product use – renal dialysis, invasive cardiovascular procedures and apheresis procedures. Reported adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, the feeling of a strong or rapid heartbeat, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst, bleeding tendencies and difficulty opening the mouth. Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening.

Customers have been instructed to discontinue use and segregate the recalled product from the rest of their inventory. Customers should then contact Baxter to arrange for return and replacement product. Customers with recalled product purchased indirectly should contact their wholesaler or distributor for return and replacement product. Customers with questions may contact the Center for One Baxter at 1-800-4-BAXTER (1-800-422-9837). Representatives will be available twenty-four hours a day, seven days a week.



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February 29th, 2008 posted by Kelly Burkholder-Allen, RN, MSEd @ 5:57 am

Were you spanked as a child? If so, you might find this interesting!

Friday, February 29, 2008
Spanking Raises Chances of Risky, Deviant Sexual Behavior
Review found physical punishment of kids linked to unprotected, masochistic sex as adults

By Amanda Gardner

THURSDAY, Feb. 28 (HealthDay News) — Researchers have uncovered another damaging consequence of spanking: risky sexual behaviors, or even sexual deviancy, when the child grows up.

“This adds one more harmful side effect to spanking,” said Murray Straus, a spanking expert who was expected to present the findings of four studies at the American Psychological Association’s Summit on Violence and Abuse in Relationships in Bethesda, Md., on Thursday.

“I think that it’s pretty powerful,” said Elizabeth Gershoff, an assistant professor at the University of Michigan’s School of Social Work. “It’s across several studies and across different forms of either risky or deviant sexual behavior.”

Straus, who was the author of all four studies, hopes the findings will raise awareness among child development experts.

“My hope is to convince my colleagues that they ought to put this in their textbooks,” said Straus, co-director of the Family Research Laboratory at the University of New Hampshire, in Durham. “It’s amazing. Something experienced by all American kids gets an average of half a page in child development textbooks, and not a single one comes to the conclusion that parents should never spank.”

Even the revered Dr. Spock, who was anti-spanking, never came right out and advised parents outright not to do it, he added. Instead, Spock advised “avoiding it if you can.”

A meta-analysis of spanking studies conducted by Gershoff found 93 percent agreement among studies that spanking can lead to such problems as delinquent and anti-social behavior in childhood along with aggression, criminal and anti-social behavior and spousal or child abuse as an adult.

“There’s probably nothing else in child development that has 93 percent agreement in results,” Straus said.

Five percent of people who have never been spanked hit their partners, versus 25 percent of those who were spanked frequently.

However, some 90 percent of U.S. parents spank toddlers, according to Straus.

The review being presented at the meeting are the first to look at the relationship of spanking to sexual behavior.

They found that spanking and other corporal punishment is associated with an increased probability of verbally and physically coercing a dating partner to have sex; risky sex such as premarital sex without using a condom; and masochistic sex such as spanking during sex.

There is a “dose response” at work here. “The more parents spank, the higher the probability of harmful side effects,” Straus noted.

Of course, there’s a similar dose response for smokers. But if someone reaches the age of 65 without developing lung cancer, it doesn’t mean that smoking isn’t harmful. It means the person was one of the lucky ones.

It’s the same with spanking, Straus said. “If a person says, ‘I was spanked, and I don’t have any interest in bondage and discipline sex, that’s correct, but it’s not because spanking is OK, it’s because they’re one of the lucky ones.”

And spanking a child once may be like picking up that first cigarette. “The trouble is, if you have a 2-year-old, you pretty soon decide you can’t avoid it. The recidivism rate for whatever ‘crime’ you correct a 2-year-old for is about 50 percent in two hours.”

“I’ve been researching corporal punishment for 30 years and, in the course of that time, the evidence has accumulated that it doesn’t work any better than non-corporal punishment but has harmful side effects. I have come to the conclusion that parents should never, ever spank because, although it does work, it’s no better than non-hitting methods that don’t have harmful side effects. If there was an FDA for spanking, they’d say use an alternative that doesn’t have harmful side effects.”

Source: http://health.usnews.com



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February 29th, 2008 posted by Kelly Burkholder-Allen, RN, MSEd @ 5:54 am

How do you track down 40,000 patients and tell them that they might have been exposed to Hepatits or even HIV?

COMMNENT” OY! This is some scary stuff!

Large-scale hepatitis alert has no precedent
By Mary Manning

Fri, Feb 29, 2008 (2 a.m.)

The campaign to notify 40,000 patients of a Las Vegas endoscopy and colonoscopy clinic that they might have been exposed to hepatitis B, hepatitis C or HIV is believed to be unprecedented in U.S. history, according to the Centers for Disease Control and Prevention.

So far, six people have been diagnosed with hepatitis C after undergoing procedures at the Endoscopy Center of Southern Nevada, according to the Southern Nevada Health District.

Previously, the largest campaign to notify patients of possible exposure to hepatitis had been in Brooklyn, N.Y., in 2001. Health officials there had tried to notify more than 2,000 patients who had gastrointestinal exams at a medical clinic after eight patients tested positive for hepatitis C.

Seven of the infected patients had been hospitalized, alerting authorities to the outbreak. The source of the infection was never pinpointed.

Since 1999 the CDC has tracked 31 outbreaks of hepatitis C.

The largest outbreak of hepatitis C in North America — affecting 99 patients — was confirmed in 2002 in connection with an eastern Nebraska cancer clinic. Patients were infected from March 2000 through December 2001. In all cases a nurse, in removing blood from intravenous tubes, used the same syringe on more than one patient.

The most recent hepatitis C outbreak came to light in June when New York City anesthesiologist Dr. Harvey Finkelstein had to notify 600 patients on whom he performed outpatient procedures in August 2006 that they might have been infected. Three of his patients were confirmed to have the virus.

In Baltimore, Md., a 79-year-old retired ironworker developed a hepatitis C infection and died in 2004 after being injected with what might have been a tainted vial of technetium-99m, a radioactive liquid designed to allow doctors to trace blood vessels. A dozen other patients were infected in the same episode, apparently from the same syringe used on the man.

Another outbreak of hepatitis C occurred in a retirement home from blood-sugar testing in 2003 and 2004, when 71 patients were infected.

Hepatitis C, a virus that attacks the liver, typically is transmitted through infected blood or semen. The disease kills as many as 10,000 people a year in the United States, according to the CDC. The majority of hepatitis C cases are the result of illicit drug use.

Mary Manning can be reached at 259-4065 or at manning@lasvegassun.com.

Source: http://www.lasvegassun.com



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