ON TARGET

ON TARGET
COMPLIMENTARY NEWS LETTER OF TARGET HEALTH® INC.

23 July 2007

I. WHAT'S NEW?
Additional Floor at 261 Madison
II. QUIZ - (Fill In The Blanks)
Using Ultrasound To Regrow Teeth
III. HISTORY OF MEDICINE
Lenox Hill Hospital - Manhattan
IV. WOMEN'S HEALTH
Postprandial Triglycerides Predictor of Coronary Events
V. PSYCHOSOMATIC MEDICINE
If You are Married, You Will Live Longer
VI. METABOLISM
Hydroxychloroquine Treatment Also Reduces Incidence of Diabetes
VII. REGULATORY AFFAIRS
Cancer Lymph Node Diagnostic Approved
VIII. TARGET HEALTH

I. WHAT'S NEW

Additional Floor at 261 Madison

As part of the growth at Target Health, we have taken an additional floor (now we have the 23rd floor and 24th floor) at 261 Madison Avenue. This gives us room for expansion and some space to spread out. Construction has begun and we will be moving in shortly

For more information about Target Health, please contact Dr. Jules T. Mitchel. Visit our Blog and Website.

II. QUIZ (Fill In The Blanks)

Using Ultrasound To Regrow Teeth

A nifty gadget promises to restore a healthy new smile, from an imperfect or damaged one. It's an ultrasound 1) ___ that fits neatly inside a person's mouth like a brace and could help to regrow damaged teeth. Two research engineers at the University of Alberta in Canada, developed the miniature device after ultrasound stimulation encouraged damaged teeth and 2) ___ tissue to regrow in animals. A scientist in Alberta's medical faculty, was able to regrow teeth in rabbits with a larger device, but only when some tooth 3) ___ remained in place. The ultrasound device could help those who have had their teeth broken while playing high impact 4) ___ such as ice hockey and rugby. The tooth brace sends low-power ultrasound 5) ___ to the damaged tooth over many months. A piezoelectric crystal generates the ultrasound by vibrating at 6) ___ above 20 kilohertz when fed an alternating voltage from an oscillator charged by a battery. Physiotherapists often use ultrasound to help broken bones knit back together, although the healing 7) ___ is not precisely understood. One theory is that pressure waves mimic the effect of strenuous exercise, loading a bone and tricking it into generating more bone cells - a process called 8) ___. El-Bialy's work on rabbits in 2003 (American Journal of Orthodontics and Dentofacial Orthopedics, vol 124, p 427) first showed that low-power ultrasound also encourages growth of dental tissue.

ANSWERS: 1) transmitter; 2) jawbone; 3) root; 4) sports; 5) pulses; 6) frequencies; 7) mechanism; 8) osteogenesis

III. HISTORY OF MEDICINE

Lenox Hill Hospital - Manhattan

Exactly 150 years ago, Lenox Hill Hospital was founded in 1857 as the German Dispensary at 132 Canal Street. On September 3, 1866, the cornerstone for a new 80-bed German Hospital and Dispensary was laid at 77th Street and Fourth Avenue (now Park Avenue). The hospital was located not far from the boundaries of a farm owned by Robert Lenox. In 1887 the hospital’s nurses training school began. In 1897, the hospital installed one of the first X-ray machines in America. By the early 1900s, private homes began to line the side streets in the Hospital's immediate neighborhood. In 1907, the first physical therapy department in the country was established at the hospital and in 1908, it was the first hospital in the US, to open a tuberculosis division. In 1918, Lenox Hill Hospital assumed its current name identifying with the area in which it was situated. In 1931, Winston Churchill was treated at Lenox Hill Hospital when he was hit by a car while crossing Park Avenue. The hospital’s list of other famous patients, would fill hundreds of pages. Over the years, Lenox Hill Hospital achieved many firsts in medicine. Today, Lenox Hill Hospital is well-known for cardiovascular care, orthopedic surgery and sports medicine, maternal and child health, bariatric surgery and gastroenterology, among other services. Approximately 325,000 patients are treated annually, including 40,000 Emergency Department visits and 20,000 ambulance and paramedic calls.

IV. WOMEN'S HEALTH

Postprandial Triglycerides Predictor of Coronary Events

Although triglyceride levels are typically obtained in the fasting state, postprandial (post-eating) hypertriglyceridemia may play an important role in atherosclerosis. As a result, a study published in the Journal of the American Medical Association (2007;298:309-316), was performed to determine the association of triglyceride levels (fasting vs nonfasting) and risk of future cardiovascular events. The investigation was a prospective study of 26,509 initially healthy US women (20,118 fasting and 6,391 nonfasting) participating in the Women's Health Study, enrolled between November 1992 and July 1995. Triglyceride levels were measured in blood samples obtained at time of enrollment and follow-up was 11.4 years. The main outcome measure was hazard ratios for incident cardiovascular events (nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization, or cardiovascular death). At the baseline visit, triglyceride levels in fasting, as well as nonfasting women, correlated with traditional cardiac risk factors and markers of insulin resistance. During a median follow-up of 11.4 years, 1,001 participants experienced an incident cardiovascular event (including 276 nonfatal myocardial infarctions, 265 ischemic strokes, 628 coronary revascularizations, and 163 cardiovascular deaths), for an overall rate of 3.46 cardiovascular events per 1,000 person-years of follow-up. After adjusting for age, blood pressure, smoking, and use of hormone therapy, both fasting and nonfasting triglyceride levels predicted cardiovascular events. Among fasting participants, further adjustment for levels of total and high-density lipoprotein cholesterol and measures of insulin resistance weakened this association. In contrast, nonfasting triglyceride levels maintained a strong independent relationship with cardiovascular events in fully adjusted models (P = .006 for trend). In secondary analyses stratified by time since participants' last meal, triglyceride levels measured 2 to 4 hours postprandially had the strongest association with cardiovascular events (P<.001 for trend), and this association progressively decreased with longer periods of fasting. According to the authors, in this cohort of initially healthy women, nonfasting triglyceride levels were associated with incident cardiovascular events, independent of traditional cardiac risk factors, levels of other lipids, and markers of insulin resistance. By contrast, fasting triglyceride levels showed little independent relationship.

V. PSYCHOSOMATIC MEDICINE

If You are Married, You Will Live Longer

Research has demonstrated associations between marital strain and prognosis of heart disease, but little research has addressed the association between specific aspects of marital strain and incident coronary heart disease (CHD). As a result, a study published in Psychosomatic Medicine (2007;69:509-513), was performed to determine if marriage and marital strain are related to 10-year CHD incidence or total mortality. From 1984 to 1987, 3,682 participants (48.5 years; 52% women) of the Framingham Offspring Study were examined. Measures of marital status, marital strain, and risk factors for CHD were collected at the baseline examination. After adjusting for age, systolic blood pressure, body mass index, cigarette smoking, diabetes, and total cholesterol/high density cholesterol, the married men compared with unmarried men were almost half as likely to die during the 10-year follow-up period. Women who "self-silenced" during conflict with their spouse, compared with women who did not, had four times the risk of dying. Men with wives who were upset by work were 2.7 times more likely to develop CHD. Marital happiness, satisfaction, and disagreements were not related to the development of CHD or death in men or women. According to the authors, the study suggests that marital conflict and strain are associated with adverse health outcomes, and that further research into the influence of marital stress on health is merited.

VI. METABOLISM

Hydroxychloroquine Treatment Also Reduces Incidence of Diabetes

Hydroxychloroquine, a commonly used antirheumatic medication, has been reported to have hypoglycemic effects, and may reduce the risk of diabetes mellitus. As a result, a study reported in the Journal of the American Medical Association (2007;298:187-1930, was performed to determine the association between hydroxychloroquine use and the incidence of diabetes in a cohort of patients with rheumatoid arthritis (RA). The investigation was a prospective, multicenter observational study of 4,905 adults with RA (1,808 had taken hydroxychloroquine and 3,097 had never taken hydroxychloroquine). None of the patients had a baseline diagnosis, or had received treatment for diabetes. Followup was 21.5 years. The main outcome measures were diabetes by self-report or hypoglycemic medication use. Results showed that during the observation period, incident diabetes was reported by 54 patients who had taken hydroxychloroquine and by 171 patients who had never taken hydroxychloroquine. The hazard ratio for incident diabetes among patients who had taken hydroxychloroquine was 0.62 compared with those who had not taken hydroxychloroquine. The risk of incident diabetes was also significantly reduced among those taking hydroxychloroquine for more than 4 years (n = 384), with an adjusted relative risk of developing diabetes of 0.23 (P < .001), compared with those who had not taken hydroxychloroquine. According to the authors, among patients with RA, use of hydroxychloroquine is associated with a reduced risk of diabetes.

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.

Cancer Lymph Node Diagnostic Approved

The presence or absence of breast cancer cells in underarm lymph nodes is a powerful predictor of whether the cancer has spread and is used to help decide appropriate therapy for a woman with metastatic breast cancer. Lymph nodes are part of the system that helps protect the body against infection. The first lymph node that filters fluid from the breast is called the "sentinel node," because that is where breast cancer cells are likely to spread first. During a lumpectomy or mastectomy to remove a breast tumor, surgeons commonly remove the sentinel node for examination under a microscope. Sometimes the sentinel node is examined immediately and if tumor cells are found, additional lymph nodes are removed. A more extensive microscopic examination, requiring one to two days for results, is almost always performed. If tumor cells are only found with the later microscopic examination, the patient may require a second surgery to remove the remaining lymph nodes. The FDA has approved the first molecular-based laboratory test for detecting whether breast cancer has spread (metastasized) to nearby lymph nodes. The GeneSearch BLN Assay detects molecules that are abundant in breast tissue but scarce in a normal lymph node. In a clinical trial, the GeneSearch BLN Assay showed strong agreement with results from extensive microscopic examination of the lymph nodes of 416 patients. The test accurately predicted that breast cancer had spread nearly 88% of the time in women with metastasis. Patients without metastasis were identified accurately 94% of the time. Most of the women were also studied to compare the BLN Assay with immediate microscopic examination during surgery. The test gave fewer false negative results, but slightly more false positive results. A false negative test result, when the cancer has actually spread, may delay the needed removal of additional lymph nodes. A false positive test, indicating metastasis when there is none, may result in a more extensive surgery and puts the women at risk of unnecessary lymphedema (swelling due to fluid build-up following lymph node removal) and other side effects. The GeneSearch BLN Assay is manufactured by Veridex, a Johnson & Johnson Company..

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 (PADT) assists companies in strategic planning from Discovery to Market Launch. Let us help you on your next project.

TARGET HEALTH INC.
261 Madison Avenue
24th Floor
New York, NY 10016
Phone: (212) 681-2100; Fax (212) 681-2105

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