High Blood Pressure Leads to Stroke: Take Your Meds!

A recent presentation last month at the International Stroke Conference held in New Orleans shows that high blood pressure is poorly controlled* in the United States.

Study findings indicated that the rate of compliance with therapy for hypertension as well as the control of blood pressure remained poor in those who had survived a stroke.  In fact, data showed that 50% of stroke survivors have poorly controlled hypertension. Several medical and lifestyle modification factors could be potential targets of intervention to bridge this evidence-practice gap.

A number of factors related to medical intervention and lifestyle were noted.  Patients who were older, female, Hispanic and had diabetes were all found to have increased incidence of poorly controlled blood pressure.

Study subjects who had a previous myocardial infarction (MI, heart attack), used alcohol and were overweight/obese were also less likely to have controlled blood pressure.

Elevated levels of cholesterol as well as being male were both indicators of non-treatment or non-compliance with regimens of anti-hypertensive medications.

However, those who were active smokers and identified as overweight or obese were found to be more likely to have treatment.

Patients who took there blood pressure medicines had lower death rates from all caused when reviewed in absolute terms, but in terms of the study these finding were not statistically significant. Yet, the findings are clearly intriguing.

Of all risks for stroke, high blood pressure is the one that is most able to be controlled and the most amenable to intervention.  Accordingly, efforts to increase diagnosis, early treatment, compliance with medication, diet and lifestyle changes are all essential in reducing the risk of stoke overall, and of recurrent stroke in those previously afflicted.

* poorly-controlled BP (>140/90) and non-treatment

Abstract 3356: Half the Stroke Survivors in the United States have Poorly Controlled Hypertension: Amytis Towfighi; Daniela Markovic; Bruce Ovbiagele; 2012 International Stroke Conference, American Stroke Association, New Orleans

Low Dose Aspirin Found to Cut Risk of Death from Numerous Cancers

“Take Two Aspirin and Call Me in the Morning” – It’s No Joke 1

One of mankind’s oldest remedies, aspirin, which has references dating it’s use to at least the 4th century BC, has received another endorsement: cancer prevention.2

A recent study published in the highly respected British journal, The Lancet, indicates that low dose aspirin may play a role in the prevention of a variety of cancers.  These include cancers of the esophagus, stomach, colon, pancreas, intestine, lung, and prostate.3

Clinical trials with aspirin as we know it today, acetyl salicylic acid (ASA), which was perfected by Felix Hoffman of Bayer Pharmaceuticals, occurred during 1897—1899 and it has been with us ever since. 2,4

ASA is the synthetic form of a naturally occurring compound, salicin, found in plants and trees, particularly the willow tree.  The famed Greek physician Hippocrates prescribed a potion or tea made from willow leaves to ease labor pains in women of that time. 2,4

We of course know of the use of aspirin for relief of aches, pains and fevers.  Aspirin is the “original NSAID (non-steroidal anti-inflammatory drug)” and has been used to treat arthritis and related conditions for years.  Over the past several decades research has indicated its important role in prevention and acute treatment of heart attacks and certain types of strokes (embolic not hemorrhagic). 2,4

Now this new study shows that daily aspirin regimens of 5 years or more substantially reduce the risk of colorectal cancer.  Researches found that this regimen reduced mortality from various cancers by 10 to 60%, depending upon the type of cancer. 3

These findings occurred in a study of over 25,000 persons, which was initially undertaken to assess the protective effects of aspirin on heart and vascular disease.  Researchers were quick to point out that the public should consult with their physician before embarking on an aspirin regimen, but do concede that the small risk of gastrointestinal (GI) bleeding is likely outweighed by the benefits in terms of cardiovascular disease prevention and now possible cancer prevention.3,5,6

During the study the overall cancer death rate reduced by 21%.  At the five-year mark in the study, death from GI cancers had reduced 54%. This positive effect however, was not seen until 10 years out.  For prostate cancer the protective effect was 15 years out. 3

The study followed patients for up to 20 years.  Those followed for this length of time showed a reduction in cancer related death of 10% for prostate cancer, 30% for lung cancer (only adenocarcinoma, the kind which NON smokers get), 40% for colorectal cancer and 60% for esophageal cancer. There were only a few deaths in the study group due to pancreatic, stomach and brain cancer, so the potential impact of aspirin on these cancers could not be accurately assessed. 3

As with prevention of heart attack, higher doses of aspirin did not offer greater benefit than long term dosing at the 75mg level.  Age was noted to be a factor with the 20-year risk of cancer death declining most dramatically among older patients in the study. 3,5,6

Again, doctors have cautioned patients not to be overly optimistic about this report, as some feel the claims made by this study are quite dramatic and require further analysis and investigation.  Patients with a history of ulcers or other GI disorders such as ulcerative colitis, Crohn’s Disease, gastric or duodenal ulcers, as well bleeding disorders are strongly advised to seek medical guidance regarding any planned use of aspirin regimens. 7,8

1. “Take Two Aspirin and Call Me in the Morning” – It’s No Joke”

2. What is Aspirin?

3. Effect of daily aspirin on long-term risk of death due to cancer: analysis of individual patient data from randomised trials – The Lancet, Early Online Publication, 7 December 2010

4. Aspirin

5. Low-Dose Aspirin Cuts Cancer Death Rate by 30%-40%

6. Is aspirin really a magic bullet for cancer?

7. Cancer doctors urge caution over taking daily aspirin

8. Daily aspirin therapy: Understand the benefits and risks

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CDC study suggests 1 in 10 children have ADHD

ADHD Diagnosis on the Rise

A recently released study from the Centers for Disease Control (CDC) indicates a dramatic increase in the number of children labeled as having Attention Deficit Hyperactivity Disorder (ADHD).  The new report has been the focus of commentary across the media.  The last study of this type indicated that as many as 7.8% of children (age 4-17) had, at one time or another, been diagnosed with ADHD (2003).  This most recent study, which focused on parental reporting of the diagnosis of ADHD, indicated that this rate had increased by a surprising large amount, 22%, to 9.5% of children ages 4-17 (2007).  1,2,3,4

It is now estimated that about one in ten school age children are currently diagnosed as having ADHD (5.4 million).  This is some one million more than was identified during the last study.  Also, about half of the children currently diagnosed as having ADHD were said to be on medication (some 2.7 million). 1

Also alarming was a reported increase in the diagnosis of ADHD among older teens (42%) and among Hispanic children (53%).  Clearly, these findings suggest some alteration in the pattern of the illness or in the manner of diagnosis. 1

Twelve states had marked increases in numbers of children diagnosed. However, they were geographically separated (such as New York, Louisiana, Virginia, Alabama).  Interestingly, these states with the highest increases were all in the east and south. 1

The new study, while indicating differences in rates of increase between various sub-groups, showed an increase in parent reported ADHD across all demographics.  Multiracial children and children on Medicaid were the groups with the highest reported rates of having been diagnosed with ADHD. 1

Clearly, there is much about ADHD we do not know or understand.  It is defined as a neurobehavioral developmental disorder.  ADHD children demonstrate attention problems and hyperactivity, with both key symptoms almost always occurring together.  What we do know is that the condition is more frequently diagnosed in boys (four times more commonly than girls), is the most common psychological/psychiatric diagnosis in children, effects as many as 5% of all children, up to 16% of school aged children, and persists in perhaps as many as 50% of adults who have the disorder.  We also know that low birth weight infants are at a much greater risk. 5

This most recent data points to confusion in explaining the reported increase.  Is it due to better diagnostic criteria being used? Is it due to greater parental and teacher awareness? Is it due to better overall pubic education and media exposure?  Are there environmental factors?  Some have pointed to a lack of certain fatty acids as a cause. An array of behavioral disorders from autism to ADHD has been blamed on various chemicals, pesticides, and vaccines. To date, a clear-cut cause based on genetics, environment, dietary factors or chemical exposure remains elusive. Lacking a clear-cut cause, treatment remains focused on symptomatic control.  1,5,6,7,8

Treatment is, of course, controversial with many opting for medications and others opting for combination of behavior modification and enhanced coping mechanism development. The use of medications while effective in up to 70% of children can be associated with dependence, drug tolerance, and side effects.  Both stimulants (such at the widely used Ritalin) and anti-psychotics have been used with success.  Interestingly, the mechanism of action of these drugs is directly opposite, which raises major questions as to the exact mode of action of these drugs in mitigating the symptoms of ADHD. 1,9,10

At this time, the key to treatment of this frustrating condition is parental awareness.  Early detection and diagnosis can lead to effective treatment for many, whether by means of behavioral therapy or medications.10

1. Increasing Prevalence of Parent-Reported Attention-Deficit/Hyperactivity Disorder Among Children — United States, 2003 and 2007 – November 12, 2010 / 59(44);1439-1443 – http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5944a3.htm?s_cid=mm5944a3_w

2. 1 in 10 US kids have ADHD; more awareness cited - http://www.google.com/hostednews/ap/article/ALeqM5jtE0v_PbmXXtyOzSXxORUAhDVyGQ?docId=4bde4aa13dfd4ace87df1d0a880cfc2b

3. One Million More U.S. Kids Are Diagnosed With Attention Deficit – http://www.bloomberg.com/news/2010-11-10/one-million-more-u-s-kids-are-diagnosed-with-attention-deficit.html

4. CDC: Childhood ADHD rate rises 22 percent – http://pagingdrgupta.blogs.cnn.com/2010/11/10/cdc-childhood-adhd-rate-rises-22-percent/

5. Attention deficit hyperactivity disorder – http://en.wikipedia.org/wiki/Attention_deficit_hyperactivity_disorder

6. Very Low Birthweight Children Have Long-Term Behavioral And Psychiatric Consequences – http://www.sciencedaily.com/releases/1997/06/970606122249.htm

7. ADDers Are More Likely to Have Fatty Acid Deficiencies -http://borntoexplore.org/omega.htm

8. Essential fatty acid metabolism in boys with attention-deficit hyperactivity disorder – http://www.ajcn.org/cgi/content/abstract/62/4/761

9. Treatment of Attention-Deficit–Hyperactivity Disorder – http://www.nejm.org/doi/full/10.1056/NEJM199903113401007

10. ADHD Diagnosis on the Rise – http://www.associatedcontent.com/article/6001472/adhd_diagnosis_on_the_rise.html?cat=25

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First Embryonic Stem-Cell Treatment on Patient Begins

It was announced this Monday that an American patient with a spinal cord injury which has caused paralysis, became the first person in the world treated with an embryonic stem cell based drug. The injections of the cell therapy grown from embryonic stem cells were administered at Shepherd Center in Atlanta. No details regarding the patient’s age or sex were released as the individual wished to remain anonymous. Only an individual with a paralyzing spinal cord injury suffered less than 14 days before being treated could qualify for entry into the study.

This treatment marks a milestone in medical research as it is the first human trial of an embryonic stem cell based therapy.  In the evolving field of what is termed regenerative medicine, this marks a major advance.  Though the research is preliminary, stem cell researchers are encouraged to see these trials begin so soon after the discovery of the properties and potential of stem cells.  It has only been 12 years since the discovery of human embryonic stem cells.  Scientist soon speculated on the regenerative properties of such cells, leading to the concept of regenerative medicine.

This patient was the first to be enrolled and treated in a safety trial, known as GRNOPC1.  The trial is being run by Geron, an American company, which is the first clinical study of any such cell treatment. Geron Corporation is based in Menlo Park, California. They have worked in conjunction with researchers at the University of California, Irvine, in the development of this drug model. The company’s stated mission is to develop first-in-class biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes. They are also actively working on advancing an anti-cancer drug and as well as a cancer vaccine that target the enzyme telomerase.  Multiple clinical trials for different cancers are ongoing.

Embryonic stem cell-derived neural cells have been used by researchers to treat nervous system disorders in animal models. In spinal cord injuries, neural cells derived from animal embryonic stem cells and injected into the spinal cord injury site produced significant recovery of the animal’s ability to move and bear weight.  In addition to spinal cord injury, GRNOPC1 may have value for other central nervous system indications, such as Alzheimer’s disease, Canavan disease and multiple sclerosis. Genron has entered into collaborations with academic groups to test GRNOPC1 in animal models of these diseases.

It was just in January of 2009 that Genron announced it had received approval from the FDA for a study of its stem-cell treatment for spinal cord injuries.  The trial was approved for up to 10 patients. At that time, the announcement capped more than a decade of advances in the company’s labs.  It also came in conjunction with an expected shift in U.S. policy toward support of embryonic stem-cell research.

This medical first does not come without controversy.  Many have voiced ethical concerns. Basic bio-science researchers believe embryonic stem cells to be the most versatile stem cells.  Using such cells they have regrown tissue and cured diseases in animals. However, to get these cells, scientists have to destroy an embryo, which many feel is akin to abortion. A judge in August blocked federal funding of embryonic stem cell research. Accordingly, researchers are proceeding with caution, being well aware of the medical complexity and social sensitivities involved in this line of work. Development of this drug has been funded totally with private dollars and his been underway for years. Embryonic stem cells are derived from embryos that develop from eggs that have been fertilized in vitro—in an in vitro fertilization clinic—then donated for research purposes with informed consent of the donors. They are not derived from eggs fertilized in a woman’s body.

Some have argued that adult stem cells can be used for these purposes, avoiding the moral questions raised by many over the use of embryonic stem cells. To date, it is not clear if adult stem cells hold the same potential, though research continues. An adult stem cell is an undifferentiated cell, found among differentiated cells in a tissue or organ. These cells can renew themselves and have the potential to differentiate into some or all of the major specialized cell types of the tissue or organ. The primary roles of adult stem cells in a living organism are to maintain and repair the tissue in which they are found.

This first patient treatment is the very beginning of human trials, labeled phase one trials.  Nearly 40% of all drugs developed never make it past phase one, which is a trial based totally on the safety of the drug or treatment.  Researchers note that despite this advance, it could be years before we know if any drug developed at this stage will actually work. The trial is formally named: hESC-Derived Oligodendrocytes – GRNOPC1 for short.

Clearly, for many suffering with chronic, debilitating, or incurable diseases and injuries this research holds great promise.  Only time will tell if the promise will be realized . . . ben kazie md

What are embryonic stem cells? – http://stemcells.nih.gov/info/basics/basics3.asp

What are adult stem cells? – http://stemcells.nih.gov/info/basics/basics4.asp

Genron – http://www.geron.com

First Embryonic Stem-Cell Trial Gets Approval From the FDA – http://online.wsj.com/article/SB123268485825709415.html

Paralyzed patient receives first embryonic stem cell treatment – http://www.myfoxtampabay.com/dpp/health/paralyzed-patient-first-embryonic-stem-cell-treatment-101110

First human study of stem cell therapy underway – http://www.necn.com/10/12/10/First-human-study-of-stem-cell-therapy-u/landing_health.html?blockID=330163&feedID=4210

Geron Corp. Begins First Embryonic Stem Cell Treatment on Patient for Spinal Cord Injuries – http://abcnews.go.com/Health/geron-corp-begins-embryonic-stem-cell-treatment-patient/story?id=11853497&page=3

hESC – Derived Oligodendrocyte Progenitor Cells (GRNOPC1) Spinal Cord Injury – http://www.geron.com/patients/clinicaltrials/hESC.aspx

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Heart Risks Major Cause of Recent Drug Recalls

It seems that the majority of drug recalls by the Food and Drug Administration (FDA) over the past 15 years have involved cardiac complications.  At least one-half of the 21 drugs pulled from the market in the U.S. for safety reasons since 1995 involved heart complications.  Some of the most notable examples of drug recalls and advisories in recent time have been Vioxx, Avandia and Meridia.

Vioxx was used to treat arthritis.  Merck recalled Vioxx after 5 years of marketing when a study suggested the drug doubled the risk of heart attacks after 18 months of treatment. An earlier study published in 2000 suggested the medicine posed heart risks and led to calls for further research into the drug’s side effects.

Avandia, at one time the world’s best-selling diabetes drug, was linked to a 43% higher risk of heart attacks in an analysis released in 2007, eight years after its approval. Glaxo, of London, said last week that it would stop promoting the drug as a result of new FDA restrictions and European regulators’ decision to withdraw the product completely.

Meridia, a 13-year-old diet pill, was tied to 16% more major cardiovascular complications in a 6 year study of 10,000 patients released this month. Abbott Park, Illinois-based Abbott no longer promotes the drug in the U.S.

This finding has resulted in calls from legislators and doctors for closer government review of side effects. FDA has used administrative and insurance claims databases to investigate safety questions about FDA regulated products.  For the most part, FDA has worked with one particular health care system at a time to evaluate a given safety issue.  FDA as set as it’s goal creation of fully integrated, linked, sustainable system.  The conceptual system which FDA is striving for has been termed their “Sentinel System”.  This ideal system will draw on existing automated health care data from multiple sources to actively monitor the safety of medical products continuously and in real-time.  FDA has implemented the Adverse Event Reporting System (AERS).  This system is a a computerized information database designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products.

Clearly, on going data collection after approval of new medications is essential in order to fully understand the potential medium and long term side-effects which may occur with new drugs.  FDA is taking a step in the right direction in utilizing modern forms of data collection and inter-connectivity in order to properly monitor adverse medication effects.  It will be interesting to see how technology impacts these efforts by FDA . . . ben kazie md

Recalled Drugs Tied to Heart Risk Spurs Call for FDA Review – http://www.bloomberg.com/news/2010-09-28/recalled-drugs-tied-to-heart-risk-spurs-call-for-fda-review.html

Guidance for Industry E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs – http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129357.pdf

FDA’s Sentinel Initiative – http://www.fda.gov/Safety/FDAsSentinelInitiative/ucm149340.htm

Guidance for Industry Diabetes Mellitus -Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes – http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0118-gdl.pdf

Adverse Event Reporting System (AERS) – http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm

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Salmonella Infection Outbreak


What is Salmonella?

Salmonellosis is an infection caused by the bacteria Salmonella. Those infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection. The illness usually lasts 4 to 7 days.  Most recover without treatment. However, in some the diarrhea may be so severe that hospitalization is required. Sometimes fatal infections occur in young children, frail or elderly people, and others with weakened immune systems. In these patients, the Salmonella infection may spread from the intestines to the blood stream, and then to other body sites and can cause death unless the person is treated promptly with antibiotics. The elderly, infants, and those with impaired immune systems are more likely to have a severe illness.

Salmonella is actually a group of bacteria that can cause diarrheal illness in humans. They are microscopic living creatures that pass from the feces of people or animals to other people or other animals. There are many different kinds of Salmonella bacteria. Salmonella serotype Typhimurium (typhoid fever) and Salmonella serotype Enteritidis are the most common in the United States. Salmonella germs have been known to cause illness for over 100 years. They were discovered by an American scientist named Salmon, for whom they are named.

Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditis, or arthritis.

What Eggs Are Affected?

Eggs affected by this recall were distributed to grocery distribution centers, retail grocery stores and food service companies which service or are located in fourteen states, including the following: Arkansas, California, Iowa, Illinois, Indiana, Kansas, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, Texas, and Wisconsin. Eggs are distributed under the following brand names: Hillandale Farms, Sunny Farms, and Sunny Meadow in 6-egg cartons, dozen-egg cartons, 18-egg cartons, 30-egg package, and 5-dozen cases. Loose eggs are packaged under the following brand names: Wholesome Farms and West Creek in 15 and 30-dozen tray packs. The loose eggs may also be repackaged by customers.

The only eggs effected by this recall have plant numbers P1860 or P1663 and Julian dates as follows:

  • P1860 – Julian dates ranging from 099 to 230
  • P1663 – Julian dates ranging from 137 to 230

Only eggs with these plant numbers are effected – even though the brand name may be the same

How Do Eggs Become Infected?

Unlike eggborne salmonellosis of past decades, the current epidemic is due to intact and disinfected grade A eggs. Salmonella enteritidis silently infects the ovaries of healthy appearing hens and contaminates the eggs before the shells are formed.

Most types of Salmonella live in the intestinal tracts of animals and birds and are transmitted to humans by contaminated foods of animal origin. Stringent procedures for cleaning and inspecting eggs were implemented in the 1970s and have made salmonellosis caused by external fecal contamination of egg shells extremely rare. However, unlike egg-borne salmonellosis of past decades, the current epidemic is due to intact and disinfected grade A eggs. The reason for this is that Salmonella enteritidis silently infects the ovaries of healthy appearing hens and contaminates the eggs before the shells are formed.

Although most infected hens have been found in the northeastern United States, the infection also occurs in hens in other areas of the country. In the Northeast, approximately one in 10,000 eggs may be internally contaminated. In other parts of the United States, contaminated eggs appear less common. Only a small number of hens seem to be infected at any given time, and an infected hen can lay many normal eggs while only occasionally laying an egg contaminated with the Salmonella bacterium.

How Does One Reduce Risk?

Eggs, like meat, poultry, milk, and other foods, are safe when handled properly. Shell eggs are safest when stored in the refrigerator, individually and thoroughly cooked, and promptly consumed. The larger the number of Salmonella present in the egg, the more likely it is to cause illness. Keeping eggs adequately refrigerated prevents any Salmonella present in the eggs from growing to higher numbers, so eggs should be held refrigerated until they are needed. Cooking reduces the number of bacteria present in an egg; however, an egg with a runny yolk still poses a greater risk than a completely cooked egg. Undercooked egg whites and yolks have been associated with outbreaks of Salmonella enteritidis infections. Both should be consumed promptly and not be held in the temperature range of 40 to 140 for more than 2 hours.

Is There Treatment If Infected?

Nontyphoid Salmonella infection is generally self-limited. Treatment for enteritis or food poisoning is controversial. Some doctors recommend no antibiotics since the disease is self-limited, while others suggest using antibiotics such as ciprofloxacin for 10-14 days. A review of 12 clinical trials showed no significant change in the overall length of the illness or the related symptoms in otherwise healthy children and adults treated with a course of antibiotics for nontyphoid Salmonella disease. Antibiotics tend to increase adverse effects and prolong Salmonella detection in stools. Patients identified as immunosuppressed (for example, patients with AIDS or undergoing cancer chemotherapy) should receive antibiotics. Some investigators believe antibiotics prolong the carrier state.  Antibiotics usually chosen to treat Salmonella infections are fluoroquinolones and third-generation cephalosporins (used in children because fluoroquinolones are not indicated for use in children). Resistance to these drugs is a potential problem for those individuals that become infected with Salmonella as drug treatment options become limited.

Clearly, common sense, attention to cleanliness, thorough cooking of eggs and general public health measures are the best protection from infection.  Once infection occurs, prompt treatment with supportive measures and medications as medically indicated is essential.  Careful attention to hand washing and personal hygiene is critical to reduce the risk of spreading infection to care givers and other family members . . . ben kazie md

No evidence that tainted eggs go beyond 2 farms – http://enews.earthlink.net/article/hea?guid=20100823/b67576dd-7b7d-4d05-a524-e98ac055c671

FDA: No evidence yet that millions of eggs tainted by salmonella extend beyond 2 Iowa farms – http://www.startribune.com/business/101287334.html?elr=KArks4OiP:DiiU1OiP:Dii_47cQiU47cQUU

Investigation Update: Multistate Outbreak of Human Salmonella Enteritidis Infections Associated with Shell Eggs – http://www.cdc.gov/salmonella/enteritidis/

CDC Investigation Announcement: Multistate Outbreaks of Human Salmonella Hartford and Salmonella Baildon Infections – http://www.cdc.gov/salmonella/baildon-hartford/index.html

Hillandale Farms of Iowa Conducts Nationwide Voluntary Recall of Shell Eggs Because of Possible Health Risk – http://www.fda.gov/Safety/Recalls/ucm223452.htm

Investigation Update: Multistate Outbreak of Human Typhoid Fever Infections Associated with Frozen Mamey Fruit Pulp – http://www.cdc.gov/salmonella/baildon-hartford/index.html

How can I tell if my eggs have been recalled? – http://www.fda.gov/Food/NewsEvents/WhatsNewinFood/ucm223536.htm

How are Salmonella infections treated? -http://www.medicinenet.com/salmonella/page3.htm#treated

Antibiotics for treating salmonella gut infections – http://www.ncbi.nlm.nih.gov/pubmed/10796610 (Sirinavin S, Garner P. Antibiotics for treating salmonella gut infections. Cochrane Database Syst Rev. 2000;CD001167)

Salmonellosis – http://www.cdc.gov/nczved/divisions/dfbmd/diseases/salmonellosis/

Salmonella enteritidis – http://www.cdc.gov/ncidod/dbmd/diseaseinfo/salment_g.htm

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New Test Predicts Onset of Alzheimer’s

Alzheimer’s disease (AD) is the most common form of dementia, affecting 5% of the population older than 65 years and 30% – 50% of those older than 80. Substantial progress has been made in identifying genes for rare forms of early onset AD and this early success significantly contributed to the  study of AD mechanisms and, more recently, multiple drug discovery approaches. Late-onset AD, the common form of the disease, has been more difficult to solve.  The combination of high-density genotyping methods, large well-characterized AD and control populations, and statistical methods to evaluate population stratification now provide the tools to identify additional genes contributing to AD risk.

Medical and clinical experts now agree that AD starts a decade or more before people have symptoms. By the time there are symptoms, it may already be far too late to save the brain. The goal then is to find ways to identify people who are getting the disease, and use those people as subjects in studies to see how long it takes for symptoms to occur and in studies of drugs that may slow or stop the disease.  Most recently, a paper just published in the Archives of Neurology, outlines a signature in spinal fluid, which very accurately predicts which patients will develop onset of AD within about 5  years. Researchers are finding a number of simple and accurate ways of detecting AD long before there are definite symptoms. In addition to work on genetic tests and spinal fluid tests they also have new PET scans of the brain that show the telltale amyloid plaques that are a unique feature of the disease. Hundreds of new drugs are undergoing testing and trials in the hope that one or more might change the course of the relentless brain cell death that robs people of their memories and abilities to think and reason. The latest PET scans for AD are not commercially available, but the spinal fluid tests are.

These new tests bring with them new questions and concerns.  Should patients and doctors use the commercially available spinal tap tests to find a disease that is yet untreatable? In research studies patients are often not told they may have the disease, but in the real world, many, if not most will be told. Many feel this should be left up to doctors and their patients. Others feel that doctors should not use the spinal fluid tests at all.  The concern is that the spinal fluid tests are not reliable enough and there can be variation in results between labs.  Finally, this type of testing has only been studied in the research settings where patients are carefully selected to have no other conditions, like strokes or depression, that could affect their memories. Some patients with severe memory loss do not have the AD. Doctors may choose to use the spinal tap test in cases where they want to be sure of the diagnosis. Also, they may wish to offer the test to people with milder symptoms who want to know whether they are developing AD.

One negative is that spinal fluid can only be obtained with a spinal tap, and that procedure, with its reputation for pain and headaches, makes some doctors and many patients nervous. The procedure involves putting a needle in the spinal space and withdrawing a small amount of fluid.  It is well-known however that spinal taps are safe and not particularly painful for most people. Still, a program of education is needed to make people feel more comfortable about having them. Since most family doctors and internists are not experienced in performing the test, there could be special spinal tap centers where they could send patients.

The new study included more than 300 patients in their 70s, 114 with normal memories, 200 with memory problems and 102 with Alzheimer’s disease. Their spinal fluid was analyzed for amyloid beta, a protein fragment that forms plaques in the brain, and for tau, a protein that accumulates in dead and dying nerve cells in the brain. To avoid bias, the researchers analyzing the data did not know anything about the clinical status of the subjects. Also, the subjects were not told what the tests showed. Nearly every person with Alzheimer’s had the characteristic spinal fluid protein levels. Nearly three-quarters of people with mild cognitive impairment, a memory impediment that can precede Alzheimer’s, had Alzheimer’s-like spinal fluid proteins. All of those with the proteins developed Alzheimer’s within five years. Nearly one-third of people with normal memories had spinal fluid indicating Alzheimer’s. Researchers suspect that those people will develop memory problems.

The prevailing hypothesis about Alzheimer’s says that amyloid and tau accumulation are necessary for the disease and that stopping the proteins could stop the disease. It is not yet known what happens when these proteins accumulate in the brains of people with normal memories. They might be a risk factor like high cholesterol levels, yet as we know, many people with high cholesterol levels never have heart attacks. Alternatively, it could mean that AD has already started and if the person lives long enough he or she will with absolute certainty get symptoms like memory loss. Many believe that when PET scans for amyloid become available, they will be used instead of spinal taps, in part because doctors and patients are more comfortable with brain scans.

It is clear that for a sensible treatment rationale to develop concerning AD, more knowledge is necessary. It may well be that drugs that are currently used to treat AD, almost always AFTER symptoms have developed, may be more useful if initiated at the first sign of development, just as statin drugs are used to lower cholesterol in patients with high levels, even if they have yet to have a stroke or heart attack.  In any event, early detection is ALWAYS a key to disease treatment and potential successful treatment outcome.  We hope that PET scans will become widely available and soon, so that more patients can be screened in a less invasive manner.  Hopefully, this and as yet to be discovered techniques and medications will finally put a halt to the expanding scourge of Alzheimer’s . . . ben kazie md

New Test Predicts Onset of Alzheimer’s by as Much as a Decade – http://www.associatedcontent.com/article/5674310/new_test_predicts_onset_of_alzheimers.html?cat=12

Spinal-Fluid Test Is Found to Predict Alzheimer’s – http://www.nytimes.com/2010/08/10/health/research/10spinal.html?_r=1&th&emc=th

Diagnosis-Independent Alzheimer Disease Biomarker Signature in Cognitively Normal Elderly People – http://archneur.ama-assn.org/cgi/content/abstract/67/8/949

Meta-analysis Confirms CR1, CLU, and PICALM as Alzheimer Disease Risk Loci and Reveals Interactions With APOE Genotypes – http://archneur.ama-assn.org/cgi/content/full/archneurol.2010.201

What is Alzheimer’s – http://www.alz.org/alzheimers_disease_what_is_alzheimers.asp

Tau protein – http://en.wikipedia.org/wiki/Tau_protein

Beta amyloid – http://en.wikipedia.org/wiki/Amyloid_beta

10 Signs of Alzheimer’s – http://www.alz.org/alzheimers_disease_10_signs_of_alzheimers.asp

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QUICK POST: FDA Panel Says Revoke Approval of Avastin (bevacizumab) for breast cancer

An advisory committee of the Food and Drug Administration (FDA) voted 12-1 to recommend revoking approval of the drug Avastin as a treatment for breast cancer, saying the drug was not helping patients. This action is a major setback for Avastin, which is now the world’s best-selling cancer drug, with global sales of about $6 billion last year. The product has at times been hailed as a near miracle, the first medicine to work by blocking the flow of blood to tumors (anti-angiogenesis drugs). Avastin, sold by Roche’s Genentech unit, will remain on the market even if the FDA follows the committee’s advice because Avastin is also permitted as a treatment for colon, lung, kidney and brain cancers. So even if the FDA does indeed take the rare move of rescinding its approval, doctors would still be able to use Avastin off-label to treat breast cancer.

This action is part of the follow-up mandated by the rapid approval process.  Rapid approval allows promising drugs to enter the market faster with the requirement that companies continue to do research on the effectiveness.  In  this case, it appears that in terms of breast cancer, there does not appear to be a major advantage in the additional use of Avastin (it is almost always used in conjunction with chemotherapy).  In this case, the system seems to be working as it should on both ends, by getting a promising product to the market quickly and then following up to be sure that the early promise is indeed realized . . . ben kazie md

F.D.A. Panel Urges Limits for Avastin – http://www.nytimes.com/2010/07/21/health/policy/21avastin.html?_r=1&hpw

FDA panel says Avastin should not be marketed for breast cancer treatment – http://www.latimes.com/news/health/la-sci-avastin-20100721,0,4084979.story

Roche May Lose $1 Billion a Year on Avastin Change – http://www.bloomberg.com/news/2010-07-20/roche-s-avastin-fails-to-win-u-s-advisory-panel-backing-for-breast-cancer.html

FDA Panel Says Avastin’s Breast Cancer Indication Should Be Removed – http://online.wsj.com/article/SB10001424052748703724104575379392504495872.html

Panel wants Avastin withdrawn for breast cancer – http://www.google.com/hostednews/ap/article/ALeqM5hsrSyNbgEjEv8fRvLyR0cVzoJQrQD9H2VIP81

Briefing Information for the July 20, 2010 Meeting of the Oncologic Drugs Advisory Committee – http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/ucm219223.htm

FDA Briefing Document Oncology Drug Advisory Committee Meeting July 20, 2010 BLA STN 125085/191 and 192 Avastin® (bevacizumab) Applicant: Genentech Inc – http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM219224.pdf

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Libido Pill for Women on Hold

Flibanserin (proposed trade name Girosa) is a drug developed by and under investigation via Boehringer Ingelheim pharmaceuticals.  It is considered a novel, non-hormonal treatment for pre-menopausal women with Hypoactive Sexual Desire Disorder (HSDD). HSDD has been a recognized distinct sexual function disorder for more than 30 years.

HSDD is the most commonly reported female sexual complaint.  It is characterized by a decrease in sexual desire that causes marked personal distress and/or personal difficulties. Studies show that about 1 in 10 women reported low sexual desire with associated distress, which may be HSDD. The neurobiology and neurochemistry of female sexual desire is complicated.  It involves interactions among multiple neurotransmitters, sex hormones and various psychosocial factors. Sexual desire is controlled in a distinct brain area.  This control involves a balance between inhibitory and excitatory neurotransmitters. Serotonine acts as an inhibitor while dopamine and norepinephrine act as stimulators of sexual desire.

Flibanserin is a 5-HT1A receptor agonist (meaning that it binds to a receptor of a cell and triggers a response by the cell) and 5-HT2A receptor antagonist (meaning it acts against and blocks an action) that had initially been investigated as an antidepressant. Early research suggests that flibanserin targets these receptors preferentially in selective brain areas. It acts to help restore a balance between inhibitory and excitatory effects.

Phase III clinical trial data presented at the 58th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco (May 2010), included data from two major North American trials (DAISY® and VIOLET®) which assessed flibanserin 100mg in pre-menopausal women suffering from HSDD. Initially over 1,300 women were enrolled in the 24 week trial with some 971 available for final analysis and review. The data demonstrated that a higher proportion of pre-menopausal women with HSDD reported improvement in their condition and a meaningful benefit from their treatment, compared to placebo.

Pre-menopausal women with HSDD report feeling an improvement in their symptoms of low desire and associated distress when taking flibanserin.  They also reported that this change had a meaningful benefit to them. These findings add to earlier data that showed positive outcomes. Women who completed 24 weeks of treatment showed statistically significant improved measures of sexual desire, overall sexual functioning, distress associated with low sexual desire, and the number of satisfying sexual events (SSE), compared with placebo.

The most common adverse events (AEs) reported in the study with flibanserin 100 mg were mild to moderate and were noted during the first 14 days of treatment. AEs reported by more women on flibanserin than on placebo included somnolence (daytime sleepiness), dizziness, fatigue, anxiety, dry mouth, nausea and insomnia. The majority of these AEs resolved with continued treatment. About 15% of women on flibanserin 100mg and 7% of women on placebo discontinued treatment due to AEs.

The US Food and Drug Administration’s (FDA) Reproductive Health Drugs Advisory Committee voted 10 to 1 on June 18 that flibanserin, 100 mg was not significantly better than placebo for HSDD. They also voted unanimously that the benefits did not compensate for its adverse effects. Although the FDA does not have to follow the advice of the advisory panel, the ruling means that approval is now unlikely in the United States unless additional data can be presented supporting the drug’s clinical benefit. Flibanserin is not as of yet approved in any country. No treatments directed toward HSDD in women are currently approved for use in the United States.  It is not clear at this time if the manufacturer will pursue additional studies or approvals outside of the US market.  HSDD remains a real and problematic issue for many women and couples.  In the era of Viagra, we can only hope that the FDA will seek to move to market medications which may have value for women seeking improved sexual function as well . . . ben kazie md

Sex and the Single Drug – http://www.nytimes.com/2010/06/27/business/27stream.html

No Sex Please, We’re Middle Class – http://www.nytimes.com/2010/06/27/opinion/27Paglia.html?ref=food_and_drug_administration

Drug for Sexual Desire Disorder Opposed by Panel – http://www.nytimes.com/2010/06/19/business/19sexpill.html

Sex, Brain, Body: Make the Connection – http://www.sexbrainbody.com/

Boehringer Ingelheim Comments on June 18th FDA Advisory Committee Meeting – http://us.boehringer-ingelheim.com/newsroom/2010/06-18-10_flibanserin_statement.html

Flibanserin – http://en.wikipedia.org/wiki/Flibanserin

Hypoactive sexual desire disorder – http://en.wikipedia.org/wiki/Hypoactive_Sexual_Desire_Disorder

FDA Advisory Committee Votes Against Flibanserin for Hypoactive Sexual Disorder – http://www.medscape.com/viewarticle/723896

Boehringer Ingelheim announces new data on flibanserin in pre-menopausal women with HSDD – http://www.eurekalert.org/pub_releases/2010-05/opr-bia051710.php

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Online Prescription Long Lash Drug May Be Risky

Latisse, a new and very popular medication for persons with a hair disorder (eyelash hypotrichosis) is a prescription product produced hy Allergan.  LATISSE® solution is a prescription treatment for hypotrichosis used to grow eyelashes, making them longer, thicker and darker. Eyelash hypotrichosis is another name for having inadequate or not enough eyelashes.

Latisse is also sold widely on the internet by clinics and various cosmetic and beauty web sites.  The Latisse that consumers order online may well be the real thing, or it could be an adulterated version, or worse, a totally fake product.  Even when the product is the real thing, ordering online may mean that patients are not taught proper safeguards related to application of the product.  They are also likely not made aware of potential problems with the use of this new product.

Hypotrichosis is a term used by dermatologists to describe a condition of no hair growth. Unlike alopecia, which is the term for hair loss where formerly there was hair growth, hypotrichosis describes a situation where there wasn’t any hair growth in the first place. Hypotrichoses (plural) then are conditions that affect individuals right from birth and usually stay with them throughout their lives.  The majority of hypotrichoses are due to genetic aberrations or defects of embryonic development. There are hundreds of types of genetic hypotrichoses. Often, affected individuals have other physical or mental problems beyond a lack of hair. Conditions such as Graham-Little syndrome, Ofuji syndrome, cartilage-hair hypoplasia, Jeanselme and Rime hypotrichosis, Marie Unna hypotrichosis, and metaphyseal chondrodysplasia, among many others, can involve the symptom of hypotrichosis.

When FDA. approved this product for marketing, they made a determination that the side effects or misuse or inappropriate use could cause harm, and that’s why Latisse is a prescription drug; if it was completely safe to use without doctor supervision, they would have deemed it over-the-counter, according to the executive director of the National Association of Boards of Pharmacy, which represents state agencies that regulate pharmacies and pharmacists.

Other than ophthalmologists, most doctors do not do eye exams before dispensing Latisse, but they do explain how to apply it. Latisse must be dabbed on the upper lash line only, since it can grow unintended hair — on the cheek, for example. People are not supposed to place it on the lower lash line or eyebrows (though some do), and they are meant to use the one-use applicators that come with Latisse to avoid infection and to give the right dose.

For patients with open-angle glaucoma or ocular hypertension, LUMIGAN ophthalmic solution can help reduce increased eye pressure, which is the only treatable glaucoma risk factor. LUMIGAN is a medication prescribed to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. LUMIGAN (bimatoprost ophthalmic solution) 0.03% has been reported to cause darkening (pigmentation) of eye color, eyelid skin and eyelashes, as well as increased growth of eyelashes. Pigmentation changes can increase as long as LUMIGAN is used. After stopping LUMIGAN®, darkening of eye color is likely to be permanent while darkening of the eyelid skin and eyelash changes may be reversible. The effects of increased darkening beyond 5 years are not known.

Most people who use Latisse or Lumigan do well.  Issues can arise such as ingrown lashes, when lashes get so long they scratch the cornea. Latisse can also reactivate dormant eye inflammation. The most common side effects are eye redness, growth of eyelashes, and itchy eyes.

Items of concern for patients to be informed about and to consider before using Latisse include:

  • Concurrent administration of LATISSE® and intra-ocular pressure (IOP) lowering prostaglandin analogs may decrease the IOP-lowering effect.
    • Patients using these products together must be closely monitored for changes to their intraocular pressure.
  • Pigmentation of the eyelids and iris may occur. Iris pigmentation is likely to be permanent.
  • Most common adverse events (incidence approximately 3% – 4%) are eye pruritus or itching, conjunctival hyperemia (red eyes), and skin hyperpigmentation.
  • LATISSE® may affect IOP though not to a level that will cause clinical harm.
  • In patients using LUMIGAN® or other prostaglandin analogs for the treatment of elevated IOP the concomitant use of LATISSE® may interfere with the desired reduction in IOP.
  • Patients using prostaglandin analogs for IOP reduction should only use LATISSE® after consulting with their physician.
  • Patients should be informed about the possibility of eyelid skin darkening, which may be reversible after discontinuation of LATISSE®.
  • Although iridal pigmentation (changes in eye color) was not reported in clinical studies with LATISSE®, patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent.
    • Increased iris pigmentation has occurred when the same formulation of LUMIGAN®) was instilled directly onto the eye.
  • Patients should be informed of the possibility of hair growth occurring outside of the target treatment area if LATISSE® repeatedly touches the same area of skin outside the treatment area.
  • They should also be informed of the possibility of disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth.
    • Eyelash changes are likely reversible upon discontinuation of treatment.

Clearly, long lashes may be esthetically and cosmetically desirable, however, patients need to be aware of all the risks before embarking on the use of this treatment.  Those risks are indeed small, but are real . . . ben kazie md

Long Lashes Without Prescription, but With Risks – http://www.nytimes.com/2010/05/02/health/02latisse.html?emc=tnt&tntemail0=y

Latisse – http://www.latisse.com/

Lumigan – http://www.lumigan.com/

LATISSE Couture Laser and Skin – http://www.latisse.bz/index.html

Congenital Hypotrichosis – http://www.americanhairloss.org/types_of_hair_loss/congenital_hypotrichosis.asp

Hypotrichosis – http://en.wikipedia.org/wiki/Hypotrichosis

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