21 October 2007
I. WHAT'S NEW?
New Publication - EHR Meets EDC
II. QUIZ - (Fill In The Blanks)
BioMedicine and Nanodiamonds
III. HISTORY OF MEDICINE
8000 BCE – Prehistoric Medicine
IV. WOMEN'S HEALTH
DNA HPV Testing Beats Pap Smear
V. PUBLIC
HEALTH
MRSA is a Major Health Problem
VI. PSYCHIATRY
Genetic Basis of Schizophrenia
VII.
REGULATORY AFFAIRS
FDA Provides Advice on Safe Sources of Puffer Fish
VIII. TARGET HEALTH
II. QUIZ
(Fill
In The Blanks)
BioMedicine and Nanodiamonds
They might not be as pretty as their much larger counterparts, but unlike a sparkling diamond ring, the tiny 1) ___ known as nanodiamonds, might actually end up doing some good in the world. Scientists at Northwestern University have demonstrated that these relatively new nanomaterials can shuttle 2) ___ drugs to cells without producing the negative effects of today's delivery agents. Clusters of the nanodiamonds surrounding the drugs block them off from 3) ___ cells, preventing unnecessary damage, and then release them upon reaching the intended targets. Just as important, the leftover diamonds, hundreds of thousands of which could cram onto the eye of a 4) ___, don't induce inflammation in cells once they've done their job. The study, the first to demonstrate the usefulness of the material in 5) ___, is published online in Nano Letters.IV. WOMEN'S HEALTH
DNA HPV Testing Beats Pap Smear
According to an article published in the New England Journal of Medicine (2007;357:1579-1588), a randomized clinical trial was carried out to determine whether testing for DNA of oncogenic human papillomaviruses (HPV) is superior to the Papanicolaou (Pap) test for cervical-cancer screening. For the study, an HPV an FDA approved assay was compared with conventional Pap testing as a screening method to identify high-grade cervical intraepithelial neoplasia in women ages 30 to 69 years. Women with abnormal Pap test results or a positive HPV test (at least 1 pg of high-risk HPV DNA/mL) underwent colposcopy and biopsy, as did a random sample of women with negative tests. A total of 10,154 women were randomly assigned to testing. Both tests were performed on all women in a randomly assigned sequence at the same session. The sensitivity of HPV testing for cervical intraepithelial neoplasia of grade 2 or 3 was 94.6%, whereas the sensitivity of Pap testing was 55.4% (P=0.01). The specificity was 94.1% for HPV testing and 96.8% (P<0.001) for Pap testing. The sensitivity of both tests used together was 100%, and the specificity was 92.5%. Triage procedures for Pap or HPV testing resulted in fewer referrals for colposcopy than did either test alone but were less sensitive. No adverse events were reported. According to the authors, compared with Pap testing, HPV testing has greater sensitivity for the detection of cervical intraepithelial neoplasia.V. PUBLIC HEALTH
MRSA is a Major Health Problem
As the epidemiology of infections with methicillin-resistant Staphylococcus aureus (MRSA) changes, accurate information on the scope and magnitude of MRSA infections in the US population is needed. As a result, a study published in the Journal of the American Medical Association (2007;298:1763-1771), was performed to describe the incidence and distribution of invasive MRSA disease in 9 US communities and to estimate the burden of invasive MRSA infections in the US. The study was an active, population-based surveillance for invasive MRSA in 9 sites participating in the Active Bacterial Core surveillance (ABCs)/Emerging Infections Program Network from July 2004 through December 2005. Reports of MRSA were investigated and classified as either health care–associated (either hospital-onset or community-onset) or community-associated (patients without established health care risk factors for MRSA). The main outcome measures were Incidence rates and estimated number of invasive MRSA infections and in-hospital deaths among patients with MRSA in the US in 2005; interval estimates of incidence excluding 1 site that appeared to be an outlier with the highest incidence; molecular characterization of infecting strains. During the study, there were 8,987 observed cases of invasive MRSA. Most MRSA infections were health care–associated: 58.4% were community-onset infections, 26.6% were hospital-onset infections, 13.7% were community-associated infections, and 1.3% could not be classified. The standardized incidence rate of invasive MRSA was 31.8 per 100,000. Incidence rates were highest among persons 65 years and older, blacks, and males. There were 1,598 in-hospital deaths. In 2005, the standardized mortality rate was 6.3 per 100 000. Molecular testing identified strains historically associated with community-associated disease outbreaks recovered from cultures in both hospital-onset and community-onset health care–associated infections in all surveillance areas. It was concluded that invasive MRSA infection is a major public health problem primarily related to health care but no longer confined to intensive care units, acute care hospitals, or any health care institution. In addition, MRSA affects certain populations disproportionately.VI. PSYCHIATRY
Genetic Basis of Schizophrenia
According to an article published in the Journal of Neuroscience (2007;27:11254-11262), schizophrenia may occur, in part, because of a problem in an intermittent on/off switch for a gene involved in making a key chemical messenger in the brain. The study also found that the gene is turned on at increasingly high rates during normal development of the prefrontal cortex, the part of the brain involved in higher functions like thinking and decision-making, but that this normal increase may not occur in people with schizophrenia. The gene, GAD1, makes an enzyme essential for production of the chemical messenger, called GABA. GABA helps regulate the flow of electrical traffic that enables brain cells to communicate with each other. It is among the major neurotransmitters in the brain. The more the gene is turned on, the more GABA synthesis can occur, under normal circumstances. Abnormalities in brain development and in GABA synthesis are known to play a role in schizophrenia, but the underlying molecular mechanisms are unknown. In this study, it was discovered that defects in specific epigenetic actions, biochemical reactions that regulate gene activity, such as turning genes on and off so that they can make substances like the GAD1 enzyme are involved. Another enzyme, Mll1, may play a role in the epigenetic actions. For genes to be turned on, temporary structural changes in certain proteins known as histones must take place to expose the genes' blueprints in DNA. Evidence was also found that, in schizophrenia, changes in Mll1 activity may interfere with this process in histones whose alterations enable the GAD1 blueprint to be exposed. According to the authors, finding more precise molecular targets for development of new schizophrenia medications is a key effort, because it can lead to more effective treatments with fewer side effects. Clozapine and other current antipsychotic medications are effective for many patients, but not all, and they can cause side effects severe enough that some people choose to stop treatment. It was also found that people with three different variations of the GAD1 gene — variations previously associated with schizophrenia — also were more likely to have indicators of a malfunction in brain development. Among them were indicators of altered epigenetic actions related to GABA synthesis.VII. REGULATORY AFFAIRS
TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available.FDA Provides Advice on Safe Sources of Puffer Fish
The FDA has released consumer and industry advisories regarding safe sources of puffer fish. Many puffer fish, also known as fugu, bok, blowfish, globefish, swellfish, balloonfish, or sea squab, contain deadly toxins that affect the central nervous system, if consumed. Puffer fish can be safely consumed when special care is taken to ensure that the fish caught are free of toxins, or when they are processed to eliminate the toxins. According to FDA, over the past year, several illnesses have been linked to puffer fish improperly processed and illegally imported into the US. The only safe sources for imported puffer fish are fish that have been processed and prepared by specially trained and certified fish cutters in the city of Shimonoseki, Japan. Additionally, puffer fish caught in the mid-Atlantic coastal waters of the US, typically between Virginia and New York, are safe to consume. Puffer fish from all other sources can either naturally contain deadly toxins or become toxic because of environmental factors and therefore are not considered safe. Symptoms of ingesting the toxins found in puffer fish include tingling around the lips and in the extremities followed by problems speaking, loss of balance, muscle weakness and paralysis, vomiting, and diarrhea. In extreme cases, there may be respiratory paralysis that can lead to death. Consumers should ask about the origin of the fish before ordering or buying. In cases where the source is uncertain or unknown, consumers should not eat the puffer fish. FDA officials are working with state and local health officials, along with food safety organizations, to raise awareness about the industry advisory to restaurants, fish markets, and food stores.VIII. TARGET HEALTH
TARGET HEALTH INC. (www.targethealth.com)is a full service eCRO with full-time staff dedicated to all aspects of drug and device development. Areas of expertise include Regulatory Affairs, comprising, but not limited to, IND, IDE, NDA, PMA and 510(k) submissions, execution of Clinical Trials, Project Management, Biostatistics and Data Management, Web Trials, utilizing Target e*CRF®, our proprietary Internet-based Clinical Trial System, and Medical Writing. TARGET HEALTH's Pharmaceutical Advisory Dream Team assists companies in strategic planning from Discovery to Market Launch. Let us help you on your next project.TARGET
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