On Target

ON TARGET
COMPLIMENTARY NEWS LETTER OF TARGET HEALTH® INC.

9 March 2008

I. WHAT'S NEW?
Target Health's Blog has over 50,000 Visits Per Month
II. QUIZ - (Fill In The Blanks)
Arthritis Medications May Reduce Risk Of Heart Attacks And Strokes
III. HISTORY OF MEDICINE - HONORING WOMEN'S HISTORY MONTH
History of Women in Medicine
IV. INFECTIOUS DISEASE
A New Arenavirus Identified in a Cluster of Fatal Transplant-Associated Diseases
V. RHEUMATOLOGY
Cognitive-Behavioral Therapy Improves Health Outcomes in RA
VI. GYNECOLOGY
Acupuncture Improves Outcomes of In Vitro Fertilization
VII. REGULATORY AFFAIRS
Heparin Safety Update
VIII. TARGET HEALTH

I. WHAT'S NEW?

Target Health's Blog has over 50,000 Visits Per Month

The Target Health Blog http://blog.targethealth.com/, the brain child of our CEO Joyce Hays, has now achieved a milestone of 50,000 visits/month. As a tribute to the quality and breadth of the Blog, we were picked up several months ago by the Wall Street Journal and just recently by President Clinton’s Foundation. The citation can be found under the Clinton Global Initiative University/2008 Reading Materials/Global Health/Maternal and Child Undernutrition: Maternal and Child Undernutrition: An Urgent Opportunity
Source: On Target: The Official Blog of Target Health Inc.

For more information, please contact Dr. Jules T. Mitchel or Joyce Hays. For new business opportunities, contact Dr. Jules T. Mitchel . Please visit our Website and Blog.

II. QUIZ (Fill In The Blanks)

Arthritis Medications May Reduce Risk Of Heart Attacks And Strokes

Patients prescribed drugs to treat 1) ___ could be at a reduced risk of heart attacks and strokes, according to a new study. An international team of researchers analyzed data from the QUEST-RA (Quantitative Patient Questionnaires in Standard Monitoring of Patients with Rheumatoid Arthritis) study. This study, which included 4,363 patients from 48 sites in 15 countries, examined the causes and effects of rheumatoid arthritis (RA), as well as the potential benefits of 2) ___. RA is a known risk factor for 3) ___ of the arteries and can lead to stroke and heart attacks occurring ten years earlier than in people without RA. However, earlier studies have shown that treating RA with 4) ___ -modifying anti-rheumatic drugs (DMARDs), such as methotrexate, may reduce this risk. The current research quantifies this risk reduction in thousands of patients in the QUEST-RA study. The study found that risk, when adjusted for age, gender, disease activity, and traditional risk factors such as lack of exercise, smoking, diabetes, and high cholesterol levels, correlated strongly with the use of 5) ___ to treat RA. Taking methotrexate -- the most widely used DMARD -- for just one year, for example, was found to be associated with an 18% reduction in risk of heart attack and an 11% decrease in risk of 6) ___. The study concluded that the data provide further support of the influence of both traditional and RA specific risk factors in the development of 7) ___ events, especially heart attack. As assessed by this study, the risk of cardiovascular disease was also lower with the prolonged use of sulfasalazine, glucocorticoids, leflunomide and TNF-± blockers. Adapted from BioMed Central/Arthritis Research & Therapy.

ANSWERS: 1) rheumatoid arthritis; 2) medications; 3) hardening; 4) disease 5) drugs; 6) stroke; 7) cardiovascular

III. HISTORY OF MEDICINE - HONORING WOMEN'S HISTORY MONTH

History of Women in Medicine

Throughout history, women's participation in the medical professions was limited by law, and the availability of education, due to the customs of the times. However, women always practiced medicine in the allied health fields like nursing, midwifery, etc. Throughout the nineteenth and twentieth centuries, women made significant gains in accessing medical education and medical work through much of the world. Through the latter half of the twentieth century, women had gains generally across the board. In the United States, for instance, women were 9% of total US medical school enrollment in 1969; this had increased to 20% in 1976. By 1985, women comprised 14% of practicing US physicians. By the beginning of the twenty-first century, in industrialized nations, women made significant gains, but have yet to achieve parity throughout the entire medical profession. For instance, women have achieved near parity in medical schools in some industrialized countries, and in the United States, women actually made the majority of the medical student body in 2003. However, the practice of medicine remains disproportionately male overall. In industrialized nations, the recent rough parity in gender of medical students has not yet trickled into parity in practice. In many developing nations, neither medical school nor practice approach gender parity. Moreover, there are skews within the medical profession: some medical specialties, such as surgery, are significantly male-dominated, while other specialties have achieved gender parity. Biomedical research and academic medical professions i.e., faculty at medical schools -- are also disproportionately male.

IV. INFECTIOUS DISEASE

A New Arenavirus Identified in a Cluster of Fatal Transplant-Associated Diseases

Three patients who received visceral-organ transplants from a single donor on the same day died of a febrile illness 4 to 6 weeks after transplantation. Culture, polymerase-chain-reaction (PCR) and serologic assays, and oligonucleotide microarray analysis for a wide range of infectious agents were not informative. As a result, a study, published in the New England Journal of Medicine (2008; 358:991-998), was performed to evaluate RNA obtained from the liver and kidney transplant recipients. For the study, unbiased high-throughput sequencing was used to identify microbial sequences not found by means of other methods. The specificity of sequences for a new candidate pathogen was confirmed by means of culture and by means of PCR, immunohistochemical, and serologic analyses. Results of high-throughput sequencing yielded 103,632 sequences, of which 14 represented an Old World arenavirus. The Arenaviridae are a family of viruses whose members are generally associated with rodent-transmitted disease in humans. Each virus usually is associated with a particular rodent host species in which it is maintained. Arenavirus infections are relatively common in humans in some areas of the world and can cause severe illnesses. Additional sequence analysis showed that this new arenavirus was related to lymphocytic choriomeningitis viruses. Specific PCR assays based on a unique sequence confirmed the presence of the virus in the kidneys, liver, blood, and cerebrospinal fluid of the recipients. Immunohistochemical analysis revealed arenavirus antigen in the liver and kidney transplants in the recipients. IgM and IgG antiviral antibodies were detected in the serum of the donor. Seroconversion was evident in serum specimens obtained from one recipient at two time points. It was concluded that unbiased high-throughput sequencing is a powerful tool for the discovery of pathogens and that the use of this method during an outbreak of disease facilitated the identification of a new arenavirus transmitted through solid-organ transplantation.

V. NEUROLOGY

NSAID Use and Risk of Hemorrhagic Stroke

The relationship between nonaspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) and hemorrhagic stroke (HS) remains unclear. As a result, a study published in the journal Stroke (2008;39:845-849) examined the risk of HS associated with the use of NANSAIDs in Koreans. The study was a nationwide, multicenter case-control study and included 940 nontraumatic acute HS cases in patients aged 30 to 84 years, with an absence of a history of stroke or hemorrhage-prone brain lesions. The control group consisted of 940 members of the community-matched to each case by age and gender. Trained interviewers obtained information on prescription drugs as well as over-the-counter drugs taken within 14 days before the onset of stroke. Potential confounders, including family histories of stroke, histories of hypertension, smoking, alcohol consumption, high salt intake, and laborious work hours were adjusted for statistically. Results showed that the proportion of NANSAIDs exposure within 14 days was 2.9% for HS patients and 2.0% for the controls. The adjusted odds ratios of stroke in NANSAIDs users compared with nonusers was 1.12 (95% CI, 0.77 to 1.65) for all HS, 1.03 (95% CI, 0.49 to 2.18) for subarachnoid hemorrhage, and 1.19 (95% CI, 0.76 to 1.87) for intracerebral hemorrhage. According to the authors, there was no increased risk of HS either subarachnoid hemorrhage or intracerebral hemorrhage found among NANSAIDs users.

VI. GYNECOLOGY

Acupuncture Improves Outcomes of In Vitro Fertilization

According to the British Medical Journal (2008;336:545-549), a study was performed to evaluate whether acupuncture improves rates of pregnancy and live birth when used as an adjuvant treatment to embryo transfer in women undergoing in vitro fertilization. The study was based on a systematic review of the literature followed by a meta-analysis. Data sources included Medline, Cochrane Central, Embase, Chinese Biomedical Database, hand searched abstracts, and reference lists. Eligible studies included randomized controlled trials that compared needle acupuncture administered within one day of embryo transfer with sham acupuncture or no adjuvant treatment, with reported outcomes of at least one of clinical pregnancy, ongoing pregnancy, or live birth. Two reviewers independently agreed on eligibility; assessed methodological quality; and extracted outcome data. For all trials, investigators contributed additional data not included in the original publication (such as live births). Meta-analyses included all randomized patients. Seven trials with 1,366 women undergoing in vitro fertilization were included in the meta-analyses. There was little clinical heterogeneity. Trials with sham acupuncture and no adjuvant treatment as controls were pooled for the primary analysis. Complementing the embryo transfer process with acupuncture was associated with significant and clinically relevant improvements in clinical pregnancy (odds ratio – OR, 1.65), ongoing pregnancy (OR, 1.87), and live birth (OR, 1.91). According to the authors, the results were robust to sensitivity analyses on study validity variables. According to the authors, the preliminary evidence from this study suggests that acupuncture given with embryo transfer improves rates of pregnancy and live birth among women undergoing in vitro fertilization.

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.

Heparin Safety Update

Adverse events, including deaths, have been associated with the use of heparin, a blood-thinning drug that contained an active pharmaceutical ingredient (API) from China. In February 2008, Baxter Healthcare Corporation recalled multi-dose and single-dose vials of heparin sodium for injection as well as HEP-LOCK heparin flush products. After launching a disciplined, methodical examination, FDA scientists have identified a previously unknown contaminant in the heparin. The agency does not have proof that this contaminant is causing the adverse events. There is an association, but not a direct causal link at this time. The agency has made available information on two tests that FDA scientists have conducted to detect the heparin-like substance, and recommend their use to manufacturers and suppliers for screening the heparin API.

Along with overseeing the recall, FDA scientists have:

Provided recommendations to health care professionals about strategies to limit the occurrence or severity of adverse reactions in cases where the use of heparin is medically necessary and Baxter heparin is the only heparin product available.
Launched a far-ranging investigation in the United States and abroad.
Inspected a New Jersey facility to find out whether the heparin could have been contaminated by its packaging.
Traveled to China to perform a thorough check of the plant that manufactures the heparin ingredient.
Notified FDA's key regulatory international partners.
Worked closely with the manufacturer and experts in academia and private laboratories to carry out a thorough chemical analysis of the suspect products. The agency made available information on two tests that FDA scientists have conducted to detect the heparin-like substance, and recommended their use to manufacturers and suppliers for screening the heparin active pharmaceutical ingredient (API).
Worked to ensure that there exists a safe and adequate supply of heparin to the U.S. market.

After conventional testing did not prove useful in detecting these contaminants, FDA experts developed new test methods that use existing state-of-the-art technologies such as nuclear magnetic resonance, capillary electrophoresis, enzymatic kinetics, and bioassay. Based on the results of the testing it was determined that the sampled products contained 5-20% of a heparin-like compound - a contaminant that mimicked heparin activity so closely that it was not recognized by routine testing. At this point, FDA does not know how the contaminant got into the heparin active pharmaceutical ingredient (API). The agency is continuing to aggressively investigate the situation.

For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

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 HEALTH INC.
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http://blog.targethealth.com
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Dr. Jules T. Mitchel, President
Ms Joyce Hays, CEO