Edmund's Newsletter
September 11, 2007
Issue: #37 Volume 7
RSS FEED
RSS FEED
Join Our List
Join Our Mailing List
In This Issue
Ibuprofen Can Slow Lung Disease In Children With Cystic Fibrosis
Landmark Study Shows Blood Pressure Drugs Cut Death Rate In Type 2 Diabetes
FDA Approves Second-Generation Smallpox Vaccine
Low Vitamin D During Pregnancy Linked to Preeclampsia
Cell Phones in Hospitals: Bad Rx
New Pharma Knowledge Base Streamlines CPOE
Reforms Recommended For CPOE Alert Systems
Believe It Or Not
News From MedWatch
Recently Approved Drugs/Indications
FDA Recalls and Safety Alerts in the Past 60 Days
Quick Links
Edmund's Blog

Edmund's Newsletter

Edmund's Web Page

Past Issues

SPECIAL THANKS TO

Michael R. Cohen
ISMP WEB SITE
President
The Institute for Safe Medication Practices

and

Dr. Stephen Barrett
Quack Watch Web Page
Quackwatch


Some links in Edmund's Newsletter will point to a page that requires registration.  In all cases the most you will have to do is fill out a simple form to enroll as a member.  In no case will I point you to a site that requires payment to view the page.

J1

PRAY FOR PEACE
ISSN Barcode

© 2001,2002, 2003, 2004, 2005, 2006, 2007

zodac sign

crutch tip


Join Our List
Join Our Mailing List
Ibuprofen Can Slow Lung Disease In Children With Cystic Fibrosis
The results of a clinical trial, published in late August in the Journal of Pediatrics, indicates that, when used as part of routine therapy, high-dose ibuprofen is safe, and effective in slowing down lung disease in children with cystic fibrosis (CF).

Headed by Dr. Larry Lands, Director of Pediatric Respiratory Medicine at Montreal Children's Hospital of the McGill University Health Centre, the multi-centre study monitored 142 children aged six to 18 with mild lung disease over two years.

Children given high-dose ibuprofen twice a day showed a significant reduction in the rate of decline in lung function, and had fewer and shorter hospital stays.

"Slowing the rate of the decline of lung function will result in enhanced longevity and quality of life for patients with CF," said Dr. Larry Lands.
Landmark Study Shows Blood Pressure Drugs Cut Death Rate In Type 2 Diabetes
The largest-ever study of treatments for type 2 diabetes has shown that a combination of two blood pressure lowering drugs reduced the risk of death, as well as the risks of heart and kidney disease. The ADVANCE (Action in Diabetes and Vascular Disease) Study was led by researchers at The George Institute for International Health who presented the results at the recent European Congress of Cardiology in Vienna.

"These results represent an important step forward in the care of people with type 2 diabetes worldwide. This treatment reduced the likelihood of dying from the complications of diabetes by almost one-fifth, and could potentially save several millions of lives over the next decade if the treatment was widely implemented," said study leader, Professor Stephen MacMahon, Principal Director of The George Institute.

More than 250 million people worldwide have type 2 diabetes, and most will eventually die or be disabled by the complications. The most common cause of death is heart disease, but kidney disease also affects a large proportion. In 2006, the United Nations called for increased international action to combat the global epidemic of diabetes.

More than 11,000 patients with type 2 diabetes in 20 countries world wide participated in the 4.3 year project. Half received daily treatment with a single tablet containing a fixed combination of two blood pressure lowering drugs (perindopril plus indapamide) and half received a matching inactive placebo.
FDA Approves Second-Generation Smallpox Vaccine
The U.S. Food and Drug Administration has licensed a new vaccine to protect against smallpox, a highly contagious disease with the potential to be used as a deadly bioterror weapon.

The vaccine, ACAM2000, is intended for the inoculation of people at high risk of exposure to smallpox and could be used to protect individuals and populations during a bioterrorist attack. It will be included in the Center for Disease Control and Prevention's (CDC) Strategic National Stockpile of medical supplies.

A worldwide vaccination program eradicated smallpox in the population. The last case of naturally occurring smallpox in the U.S. was in 1949 and the last case in the world was reported in Somalia in 1977. Known stockpiles of the virus are kept only in two approved labs in the United States and Russia. The CDC considers it a Category A agent, meaning it presents one of the greatest potential threats for harming public health.

Smallpox is caused by the variola virus, a virus that emerged in human populations thousands of years ago. It spreads through close contact with infected individuals or contaminated objects, such as bedding or clothing. There is no FDA-approved treatment for smallpox and the only prevention is vaccination.

"The licensure of ACAM2000 supplements our current supply of smallpox vaccine, meaning we are more prepared to protect the population should the virus ever be used as a weapon," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "This vaccine is manufactured using modern cell culture technology allowing rapid and large scale production of a vaccine with consistent product quality."
Low Vitamin D During Pregnancy Linked to Preeclampsia
Vitamin D deficiency early in pregnancy is associated with a five-fold increased risk of preeclampsia, according to a study from the University of Pittsburgh Schools of the Health Sciences reported this week in the Journal of Clinical Endocrinology and Metabolism.

A serious complication of pregnancy marked by soaring blood pressure and swelling of the hands and feet, preeclampsia is the leading cause of premature delivery and maternal and fetal illness and death worldwide, conservatively projected to contribute to 76,000 deaths each year. Preeclampsia, also known as toxemia, affects up to 7 percent of first pregnancies, and health care costs associated with preeclampsia are estimated at $7 billion a year in the United States alone, according to the Preeclampsia Foundation.

"Our results showed that maternal vitamin D deficiency early in pregnancy is a strong, independent risk factor for preeclampsia," said Lisa M. Bodnar, Ph.D., M.P.H., R.D., assistant professor of epidemiology at the University of Pittsburgh Graduate School of Public Health (GSPH) and lead author of the study. "Women who developed preeclampsia had vitamin D concentrations that were significantly lower early in pregnancy compared to women whose pregnancies were normal. And even though vitamin D deficiency was common in both groups, the deficiency was more prevalent among those who went on to develop preeclampsia."

For this investigation, Dr. Bodnar and her colleagues evaluated data and banked blood samples taken from women and newborns between 1997 and 2001 at Magee-Womens Hospital of the University of Pittsburgh Medical Center (UPMC) and affiliated private obstetrician practices. Data were analyzed for 1,198 women enrolled in the Pregnancy Exposures and Preeclampsia Prevention Study, a prospective survey designed to examine factors that may predispose women to preeclampsia. Out of this group, 55 cases of preeclampsia and 220 controls were selected for further study.
Cell Phones in Hospitals: Bad Rx
A new Dutch study on mobile phone signals finds that using a cell phone in restricted areas, such as hospitals, can be dangerous. In the study, published Wednesday in the online journal Critical Care, researchers measured the impact of electromagnetic interference (EMI) from cell phone use on hospital equipment such as ventilators and pacemakers. Signals that were equal in strength to those given off by second- and third-generation mobile phones significantly interfered with medical devices, and the study's authors categorized 75% of those incidents as "hazardous," meaning that the interference had a direct impact on patient health, or "significant," indicating that it distracted health care providers. Hazardous incidents included the sudden switching off or restarting of machines - which could mean disruption of a patient's feeding tube, ventilator, pacemaker or dialysis machine - and most events occurred when mobile phones were within 3 cm of critical-care equipment.

Dr. Erik van Lieshout, a critical-care physician at the University of Amsterdam's Academic Medical Center, and his team were prompted to begin their study last year, when they wanted to use 3G mobile phone technology to monitor mobile intensive care units remotely. They asked a Dutch telecom company if it would be safe to use UTMS, or Universal Mobile Telecommunications System, technology - which, like W-CDMA in the U.S., facilitates data transfer - near medical devices. The company didn't know. So van Lieshout and his colleagues decided to evaluate the impact of cell signals themselves; they tested the signals' effect on 61 medical devices and found that 26 (or 43%) were disrupted by EMI. Most incidents were caused by a GPRS (General Packet Radio Service) signal, a mobile data service that handles heavy-duty data transfer in international GSM networks, used by companies such as Cingular/AT&T and T-Mobile.

First-generation cell phones handled only voice data, but subsequent generations have tacked on technology that allows data transmission, which uses more electricity than older phones - it's that extra juice that researchers think interferes with medical devices. Though cell phone technology differs in the U.S., Europe and Asia, the study's authors say that, in general, 10% of medical devices experience interference from second-generation mobile phones, and that while critical incidents are rare they are "potentially lethal and...are not recognized as such."

In their research, van Lieshout and colleagues generated maximum mobile phone power signals with a signal generator, rather than with actual phones, in order to achieve results that could be replicated in other studies. Mobile phones use more power in low-coverage areas or when they're far from a cell tower; with greater coverage and close proximity to a tower, phones use less power. "It's possible that in many hospitals there is low coverage because of the concrete in the building, and it's possible that your mobile phone is transmitting like hell to get in contact with the base station," says van Lieshout. His research team proposes the one-meter rule, which recommends that mobile phones be used more than three feet from medical equipment - or not at all in patient areas, if possible.
New Pharma Knowledge Base Streamlines CPOE
Although computerized physician order entry (CPOE) offers the potential to save lives and reduce medical costs, it hasn't yet garnered widespread acceptance. According to the results of a questionnaire administered in a study by Harvey Murff, M.D., of Brigham & Women's Hospital in Boston and Joseph Kannry, M.D., of Mount Sinai-NYU Health Systems in New York, published in the Journal of the American Medical Informatics Association, one of the biggest obstacles to acceptance is the difficulty of executing tasks "in a straightforward manner." Physicians find it takes longer to type prescriptions into the system than it does to write prescriptions on a pad in the traditional way.

Suppose there were a way to streamline the process of entering orders that made it as fast as jotting a prescription on a pad, and, for more complex prescriptions, even faster. According to First Databank of San Bruno, Calif., one now exists.

At the recent annual Healthcare Information & Management Systems Society (HIMSS) conference in San Diego, First Databank announced the launch of its OrderView Med Knowledge Base, which, according to the company, is the first commercial medication database designed specifically for CPOE streamlined for this practice. It's "order-centric," according to First DataBank's product management director, Virginia Halsey.

Previously, CPOE systems have imported preexisting databases originally designed for other purposes and reshaped them to fit into CPOE systems. OrderView, however, is built from scratch, designed specifically to optimize CPOE system functions (especially the optimization of database navigation by users). It addresses the usability problems of early CPOE systems in many different ways.


Reforms Recommended For CPOE Alert Systems
One problem hospitals that have installed a computerized physician order entry (CPOE) system have been grappling with is the torrent of medical alerts generated by this technology.

Mark Siska, medication clinical systems manager of pharmacy services at the Mayo Clinic in Rochester, Minn., and Scott McCreadie, Pharm.D., strategic projects coordinator for the University of Michigan Health System, addressed these issues in their presentation at the 2006 Annual HIMSS (Healthcare Information & Management Systems Society) Conference in San Diego.

The CPOE system at the University of Michigan Health System triggered alerts for 90% of new orders in January 2003. McCreadie emphasized, "That's almost every single new order." Several recently published studies have found that most CPOE-generated alerts are overridden-with an override rate as high as 91% in one study. Reasons for overrides include the patient has tolerated the drug in question in the past and the patient is currently taking (and tolerating) the drug in question.

An excessive number of alerts has the potential to increase the risk that the alerts, including those containing important information, will be ignored. Should CPOE-alert-generating systems be abandoned or can they be improved upon?

Siska and McCreadie made several recommendations to improve these systems. For starters, CPOE databases need to be purged of false positive alerts. At the University of Michigan, a systematic effort to reduce alert noise by careful tuning to filter out false positives decreased the number of alerts by 40%.
Believe it or not

Microwave Popcorn Can Be Dangerous

Wayne Watson loved microwave popcorn so much he would eat at least two bags each night, breathing in the steam from the just-opened package, until doctors told him it may have made him sick.

Watson, whose case of "popcorn lung" is the sole reported case of the disease in a non-factory worker, said he is convinced his heavy consumption of popcorn caused his health problems.

In an interview with The Associated Press on Wednesday, the 53-year-old furniture salesman had a message to convey: "America: Read the labels, and just be careful about what we put into our bodies and always practice moderation," Watson said. "Don't go crazy."

Popcorn flavoring contains the chemical diacetyl, which has been linked to lung damage in factory workers testing hundreds of bags of microwave popcorn per day and inhaling its fumes. The chemical is a naturally occurring compound that gives butter its flavor and is also found in cheese and even wine, according to the National Institute of Occupational Safety and Health.

It's been approved by the Food and Drug Administration as a flavor ingredient, but hundreds of workers have sued flavoring makers in recent years for lung damage.

There are no warnings from federal regulators, nor is there medical advice on how consumers should treat news of the rare, life-threatening disease, bronchiolitis obliterans, also known as popcorn lung.

Dr. Cecile Rose, a lung specialist at the National Jewish Medical and Research Center in Denver who diagnosed Watson's case in February, told the AP that no definite link has been established between Watson's heavy popcorn consumption and his lung disease, but that "the possibility raises public health concerns."

Doctors tested Watson's home for levels of diacetyl fumes and found that while popcorn was microwaved in the kitchen, peak levels of the fumes were similar to those measured in factories, Rose said.

While she still lets her kids microwave popcorn at home, Rose said she is concerned that the high levels of fumes measured at Watson's home could be present anytime consumers microwave popcorn, and that these high levels _ and not just the cumulative effect of exposures in the factory _ could be a factor in causing the disease.

"We don't know yet. We think it's a possibility," said Rose, who recommended the popcorn bags be tested further.

On Wednesday, the nation's largest microwave popcorn maker, ConAgra, said it would stop using diacetyl within a year out of concern for its workers _ not because of risks to consumers. ConAgra makes Act II and Orville Redenbacher brands.

The Flavor and Extract Manufacturers Association said that Rose's finding does not suggest a risk from eating microwave popcorn.

Watson said he still craves popcorn but has taken his doctors' advice and snacks now on fruits and vegetables. He said his breathing has improved and he's lost 35 pounds. He no longer uses an inhaler or takes steroids.
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
 
Recommend Edmund's Newsletter
Edmund's Newsletter is published for only one reason and that is expand our knowledge base, join people together with like minds and to disseminate valuable information.
If you feel this newsletter is of worth, please pass it along to your friends and colleagues.
As you probably know, word of mouth is the best form of advertising! So, to help spread the word about Edmund's Newsletter, I set up an easy-to-use form for you to use. Feel free to recommend my newsletter to a friend, family member, or colleague! Send as many recommendations as you want; there's always room for another subscriber!
Thank you

Edmund