Edmund's Newsletter
January 13, 2009
Issue: #2 Volume 9
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In This Issue
Investigation of Patients Treated by an HIV-Infected Cardiothoracic Surgeon
Recommended Adult Immunization Schedule --- United States, 2009
Antipsychotic Drugs Double Risk of Death Among Alzheimer's Patients
Angina: New Drug Gets Right To The Heart Of The Problem
High Insulin Levels Raise Risk of Breast Cancer in Postmenopausal Women
Avian Flu Becoming More Resistant to Antiviral Drugs
Nose-Spray Vaccine Against Botulism Effective in Early Tests
Believe It Or Not
News From MedWatch
Recently Approved Drugs/Indications
FDA Recalls and Safety Alerts in the Past 60 Days
Drug Shortages
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Investigation of Patients Treated by an HIV-Infected Cardiothoracic Surgeon
Transmission of human immunodeficiency virus (HIV) from an infected health-care worker to patients is rare (1), with the greatest potential for occurrence during exposure-prone, invasive surgical procedures in which the blood of the health-care worker might come into contact with patients' blood or mucous membranes. When a surgeon is discovered to have HIV infection, a decision must be made about notification of patients, but only limited data are available to guide decision-making. Such notifications generally are decided upon on a case-by-case basis, taking into account such factors as the nature of the procedures performed, the infection-control knowledge and practices of the infected surgeon, the presumed likelihood of transmission, and available resources (2). This report describes the case of a cardiothoracic surgeon in Israel specializing in open-heart procedures (coronary artery bypass grafting and valve surgery) who was found to be HIV positive in January 2007 during evaluation for fever of recent onset. The duration of infection was unknown. A lookback investigation of patients operated on by the infected surgeon during the preceding 10 years was conducted under the auspices of the Israel Ministry of Health to determine whether any surgeon-to-patient HIV transmission had occurred. Of 1,669 patients identified, 545 (33%) underwent serologic testing for HIV antibody. All results were negative. A Ministry-appointed panel of experts delineated conditions under which the surgeon could resume work. The results of this investigation add to previously published data indicating a low risk for provider-to-patient HIV transmission.

The surgeon had been in practice for more than 2 decades and performed approximately 150 procedures per year. The surgeon reported no risk factors for HIV and had no available record of prior HIV testing. The surgeon was aware of and reportedly compliant with institutional infection-control guidelines and did not report any incidents of blood exposures that might have placed patients at risk.

At the time of diagnosis, the surgeon's CD4 T-cell count was 49 cells/µL, and HIV RNA was >100,000 copies/mL. The surgeon had a protective serum level of hepatitis B surface antibody and was seronegative for hepatitis C virus (HCV) antibody.

Recommended Adult Immunization Schedule --- United States, 2009
The Recommended Adult Immunization Schedule has been approved by the Advisory Committee on Immunization Practices, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American College of Physicians.

Suggested citation: Centers for Disease Control and Prevention. Recommended adult immunization schedule---United States, 2009. MMWR 2008;57(53).

The Advisory Committee on Immunization Practices (ACIP) annually reviews the recommended Adult Immunization Schedule to ensure that the schedule reflects current recommendations for the licensed vaccines. In October 2008, ACIP approved the Adult Immunization Schedule for 2009. No new vaccines were added to the schedule; however, several indications were added to the pneumococcal polysaccharide vaccine footnote, clarifications were made to the footnotes for human papillomavirus, varicella, and meningococcal vaccines, and schedule information was added to the hepatitis A and hepatitis B vaccine footnotes.

Additional information is available as follows: schedule (in English and Spanish) at http://www.cdc.gov/vaccines/recs/schedules/adult-schedule.htm; adult vaccination at http://www.cdc.gov/vaccines/default.htm; ACIP statements for specific vaccines at http://www.cdc.gov/vaccine/pubs/acip-list.htm; and reporting adverse events at http://www.vaers.hhs.gov or by telephone, 800-822-7967.

Antipsychotic Drugs Double Risk of Death Among Alzheimer's Patients
New research into the effects of antipsychotic drugs commonly prescribed to Alzheimer's patients concludes that the medication nearly doubles risk of death over three years.

The study, funded by the Alzheimer's Research Trust, was led by Prof Clive Ballard's King's College London team and is published in Lancet Neurology on 9 January.  

The study involved 165 Alzheimer's patients in care homes who were being prescribed antipsychotics. 83 continued treatment and the remaining 82 had it withdrawn and were instead given oral placebos.

Findings showed a significant increase in risk of death for patients who continued taking antipsychotic medication. The difference between the two groups became more pronounced over time, with 24-month survival rates for antipsychotic-treated patients falling to 46% versus 71% on the placebo and at 36 months it was 30% versus 59%. It means that after three years, less than a third of people on antipsychotics were alive compared to nearly two thirds using the dummy drug.

Angina: New Drug Gets Right To The Heart Of The Problem
A compound designed to prevent chest pains in heart patients has shown promising results in animal studies, say scientists. In the second issue of the British Journal of Pharmacology to be published by Wiley-Blackwell, researchers from the Centre de Recherche Pierre Fabre in France, show that the novel compound F15845 has anti-angina activity and can protect heart cells from damage without the unwanted side effects often experienced with other drugs.

Because F15845 does not interfere with heart function, as some conventional drugs such as beta blockers do, it could be given as part of a combination therapy. "It's completely different from other anti-angina drugs which directly interact with the function of the heart. So the idea is to do a co-administration with conventional heart drugs such as beta blockers," says lead author of the study, Bruno Le Grand from the Centre de Recherche Pierre Fabre in Castres, France.

The drug works by blocking excess influxes of sodium into heart cells through 'gate' proteins called sodium channels. High levels of sodium in heart cells are associated with low oxygen levels, which cause angina and can in turn lead to the build up of toxic concentrations of calcium that are lethal to cells. A number of drugs that target sodium channels can block the influx, but they act universally on heart cells and can sometimes cause further heart irregularities.

High Insulin Levels Raise Risk of Breast Cancer in Postmenopausal Women
Higher-than-normal levels of insulin place postmenopausal women at increased risk of breast cancer, researchers at Albert Einstein College of Medicine of Yeshiva University report. Their findings, published in the January 7 issue of the Journal of the National Cancer Institute, suggest that interventions that target insulin and its signaling pathways may decrease breast cancer risk in these women.


Howard Strickler, MD, MPH   Marc Gunter, PhDBreast cancer is the most common cancer among women in the United States. Last year, approximately 182,000 women were diagnosed with breast cancer and more than 40,000 died from the disease. The majority of breast cancers arise in women past the age of menopause.

Obesity is a well-established risk factor for postmenopausal breast cancer, but just how obesity and breast cancer are connected is unclear. Many researchers have assumed that the link is estrogen - a hormone that is known to increase breast-cancer risk and is found at higher-than-average levels in obese women. But obese women also have other hormonal imbalances that may play a role in triggering breast cancer. One such imbalance is elevated levels of insulin, which stimulates the growth of breast cells in tissue culture. The Einstein study is the first to prospectively identify insulin's role in breast cancer while controlling for estrogen levels.

Avian Flu Becoming More Resistant to Antiviral Drug
Researchers using Google Earth technology are able to visually chart individual outbreaks of the avian flu as it has spread outward from China over the past decade, including gene mutations that are causing a resistance to a major class of antiviral drugs.  
A new University of Colorado at Boulder study shows the resistance of the avian flu virus to a major class of antiviral drugs is increasing through positive evolutionary selection, with researchers documenting the trend in more than 30 percent of the samples tested.

The avian flu, an Influenza A subtype dubbed H5N1, is evolving a resistance to a group of antiviral drugs known as adamantanes, one of two classes of antiviral drugs used to prevent and treat flu symptoms, said CU-Boulder doctoral student Andrew Hill, lead study author. The rise of resistance to adamantanes -- which include the nonprescription drugs amantadine and rimantadane -- appears to be linked to Chinese farmers adding the drugs to chicken feed as a flu preventative, according to a 2008 paper by researchers from China Agricultural University, said Hill.

In contrast, resistance of the avian flu virus to the second, newer class of antiviral drugs that includes oseltamivir -- a prescription drug marketed under the brand name Tamiflu -- is present, but is not yet prevalent or under positive genetic selection, said Hill of CU-Boulder's ecology and evolutionary biology department. The CU findings should help health administrators around the world plan for the possibility of an avian flu pandemic.

Nose-Spray Vaccine Against Botulism Effective in Early Tests
A preclinical study found a new nasal spray vaccine to provide complete protection against a major botulism toxin, according to a study published today in the Nature journal Gene Therapy.

Botulism is caused by a bacterium, Clostridium botulinum, which produces toxins that cause paralysis and often death, as the muscles that control breathing fail. Out of an average of 145 U.S. cases each year, 65 percent are infant botulism (infants' intestines, unlike adults, are vulnerable to spore-containing dust), 20 percent are wound botulism (bacteria colonizes the wounds of severely injured patients) and about 15 percent are food-borne (improperly stored food can harbor C. botulinum), according to the U.S. Centers for Disease Control and Prevention (CDC). Botulinum neurotoxins (BoNTs) have been designated Category A bioterrorism agents that pose a high risk to national security because they are deadly, easily prepared and could conceivably be spread by inhalation.


Researchers are working to design a botulism vaccine that adds a second layer of immune protection against exposure to BoNTs. When complete, it would prime the disease-fighting cells in mucous membranes lining the nose, those most likely to be exposed first, along with those in the blood. Standard vaccines, given by injection, prepare only the blood-based immune system to fight a given disease. Secondly, the hope is that a new, well-defined subunit vaccine will enable authorities to provide an effective vaccine without having to mass-produce the actual toxin, the hazardous first step in the manufacture of the current, stockpiled vaccine.

Believe it or not
Woman allegedly tries to kill hubby with eye drops

A 40-year-old southwest Missouri woman is accused of trying to kill her husband by spiking his tea with a half bottle of Visine eye drops. Greene County deputies said the woman was jailed Thursday night on $100,000 bond on a first-degree assault charge.

She was arrested late Wednesday after a co-worker told Greene County deputies that the woman told her about the plot to kill her husband.

A probable cause statement said the husband told investigators he'd been having stomach problems for the past two months.

The statement said poison control experts told a detective that ingesting too much Visine would lead to a coma and other "serious symptoms."

Authorities say the woman researched other means of killing her husband when the first attempt didn't work.
News From MedWatch
Keep up-to-date on all of the recent MedWatch reports that gives you timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration by  CLICKING HERE
 
Recently Approved Drugs/Indications
Keep up-to-date on all of the recently approved drugs and/or approved new indications on already FDA approved drugs by CLICKING HERE
 
FDA Recalls and Safety Alerts in the Past 60 Days:
To see a list of all FDA Recalls and product safety alerts for the last 60 days CLICK HERE
 
Drug Shortages:
As many of you are aware, many drugs in the US are either unavailable or in short supply.  To view a list of these drugs CLICK HERE
 
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