PM360 January 2010

Hot Topics / Healthcare Highlights

Sensitive Skin
Hear and ear have a long-standing association (after all, you can’t even spell hear without ear), but soon you may be able to listen without the use of ears. A new apparatus that converts sounds to vibrations makes it possible for people to perceive and recognize sounds through their skin. This device, named the Monitor, could help the deaf and blind or severely hearing impaired better navigate and understand their surroundings. Parivash Ranjbar, an engineering researcher, developed the Monitor and is submitting his findings in a new dissertation at Örebro University in Sweden. The device allows sounds to keep their distinct character while being converted to lower frequencies the skin can perceive. Ranjbar’s deaf-blind trial subjects were easily able to identify sounds from both indoors and outdoors, even if they were born deaf. One subject was even able to understand a conversation after some brief training. The Monitor consists of a microphone, a processor, and a vibrator, but is small enough to carry. It is also baby friendly, as the vibrator can be mounted in pacifiers or bottle nipples. This could help any infants born deaf and give their parents the ability to use their voices to communicate with their babies. —Andrew Matthius

Risky Business
We all may have been taught in preschool that sharing is a good thing, but doctors may want to consider the possible outcomes when making mutual medical decisions with their patients. A study published in the December issue of the journal Arthritis Care & Research suggests increasing patients’ responsibility may decrease their willingness to accept risky treatments. Liana Fraenkel, MD, MPH, of Yale University School of Medicine, and Ellen Peters, PhD, of Decision Research, enlisted 216 participants in their medical decision making study. The participants, 70% of whom were Caucasian and 62% female with a mean age of 59, were asked to watch a video of a new medication with a rare risk of a serious side effect. One video described a new heart medication with a risk of developing jaw necrosis, and another video described a new chronic pain medication with a risk of progressive multifocal leukoencephalopathy relevant to patients with rheumatic diseases. Then participants were provided with two consecutive sets of instructions. In the first set, they were told the doctor was prescribing them this medication. The second set informed them the doctor was leaving the decision completely up to them. “We found that highlighting the perception of having a choice increases patients' worry about the risks of adverse events and decreases their willingness to accept treatment,” said Dr. Fraenkel. “Clinicians should be aware that promoting increased patient responsibility for decisions involving their healthcare may be associated with lower uptake of risky procedures or interventions.” —A.M.

Remote Access
Medical diagnoses just became faster, more accurate, and possible from remote locations—with the use of an iPhone with special software. A study presented in late November at the annual meeting of the Radiological Society of North America revealed that radiologists using an iPhone G3 equipped with OsiriX Mobile medical image-viewing software were able to accurately diagnose acute appendicitis. Radiologists were sent CT examinations of a patient’s abdomen and pelvis over an encrypted wireless network to an iPhone. “The scans can be read in full resolution with very little panning, and the software allows the reader to zoom and adjust the contrast and brightness of the image,” said the study’s lead author Dr. Asim F. Choudhri. “The radiologist is evaluating actual raw image data, not snapshots.” Of the 25 patients in the study, 15 were correctly diagnosed with acute appendicitis on 74 of 75 interpretations and only one false negative by the five participating radiologists.

Appendicitis is an inflammation of the appendix that causes it to rupture, which can lead to a life-threatening infection. The risk of rupture increases with every second that diagnosis is delayed by waiting for a radiologist to interpret CT scans or to consult with a specialist. The faster radiologists get the image, the faster treatment can begin. “The goal is to improve the speed and accuracy of medical diagnoses,” Dr. Choudhri said. "When we can make these determinations earlier, the appropriate surgical teams and equipment can be assembled before the surgeon even has the chance to examine the patient."
—A.M.

FDA UPDATE
Agriflu
Agriflu, manufactured by Novartis in Siena, Italy, was approved with the FDA’s accelerated approval pathway for anyone 18 years old or older to prevent disease caused by influenza virus subtypes A and B. The vaccine is likely to be effective in preventing seasonal influenza, but Novartis is required to conduct further verifying studies. Agriflu is administered as a single injection in the upper arm, and side effects include pain, swelling, and redness at the injection site, headache, muscle aches, and malaise.

Cymbalta
Eli Lilly’s Cymbalta has been approved for the maintenance treatment of generalized anxiety disorder (GAD) in adults. This is Cymbalta’s sixth FDA approval for adults, with previous approvals for acute and maintenance treatment of major depressive disorder, management of diabetic peripheral neuropathic pain and fibromyalgia, and acute treatment of GAD. Side effects include nausea, headache, dry mouth, diarrhea, dizziness, constipation, fatigue, and increased sweating.

Zyprexa
Eli Lilly’s Zyprexa has been approved in tablet form as an option for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents ages 13 to 17. The updated label highlights the need for a comprehensive treatment program, which could include psychological, educational, and social interventions. The updated label also warns of the increased potential for weight gain and hyperlipidemia in adolescents. —A.M.