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6 November 2006

I.  WHAT'S NEW?
Data Management At Target Health
II.  QUIZ - (Fill In The Blanks)
    Palliative Care
III. HISTORY OF MEDICINE
    Malaria
IV. PUBLIC POLICY
    Clinical Trial Policy For Medicare and Medicaid Patients
V. EPIDEMIOLOGY
Outcome Of Dental Treatment During Pregnancy
VI. SPORTS MEDICINE
Treatment of Tennis Elbow
VII. PSYCHOSOMATIC MEDICINE
Phobic Anxiety And Risk of Ventricular Arrhythmias
VIII. REGULATORY AFFAIRS
    How To Get FDA To Approve Illegally Marketed Drugs
IX. TARGET HEALTH

I. WHAT'S NEW

Data Management At Target Health 

Target Health is pleased to announce the expansion of our data management activities. Since about 85% of data management now occurs within Target e*CRF our proprietary EDC system, many of our clients are now contracting with us to do data management. We have just hired 2 data managers, both with advanced degrees in biostatistics, to bolster our data management and biostatistical operations.  For more information about Target Health, please contact  Dr. Jules T. Mitchel.

II. QUIZ (Fill  In The Blanks)

Palliative Care

Palliative care, from the Latin palliare, to cloak, is any form of medical care or treatment that concentrates on reducing the severity of the 1) ___ of a disease, or slow the disease's progress, rather than provide a 2) ___. However, it may occasionally be used in conjunction with curative therapy, providing that the curative therapy will not cause additional 3) ___. It aims at improving quality of life, by reducing or eliminating 4) ___ and other physical symptoms, enabling the patient to ease or resolve psychological and spiritual problems, and supporting the partner and family. A highly debated aspect of palliative care is whether or not to allow the use of 5) ___ and sedatives for chronic pain. Palliative care is sometimes confused with 6) ___ care, where it is significant; however, palliative care is, or should be, a part of all medical care.

ANSWERS: 1) symptoms; 2) cure; 3) morbidity; 4) pain; 5) narcotics; 6) hospice

III. HISTORY OF MEDICINE

Malaria

The word, Mal’aria, was introduced to English by Horace Walpole, who wrote in 1740 about a “horrid thing called mal’aria, that comes to Rome every summer and kills one.” The term malaria, without the apostrophe, evolved into the name of the disease only in the 20th century. Up to that point the various intermittent fevers had been called jungle fever, marsh fever, paludal fever, or swamp fever. By the beginning of the Christian era, malaria was widespread around the shores of the Mediterranean, in southern Europe, across the Arabian peninsula and in Central, South, and Southeast Asia, China, Manchuria, Korea, and Japan. Malaria probably began to spread into northern Europe in the Dark and Middle Ages via France and Britain. (edited by Alex Hays)

IV. PUBLIC POLICY

Clinical Trial Policy For Medicare and Medicaid Patients  

On September 19, 2000, the Health Care Financing Administration (now the Centers for Medicare & Medicaid Services (CMS)) implemented a Clinical Trial Policy through the national coverage determination (NCD) process. The Clinical Trial Policy was developed in response to a June 7, 2000 executive memorandum, issued by President Clinton, directing Medicare to pay for routine patient costs in certain clinical trials. The 2000 Clinical Trial Policy requires trials to be "qualified" prior to payment of routine costs. The policy provides for certain trials to be deemed qualified; i.e., those that are approved and funded by a Federal agency or have an IND approval from FDA or are IND exempt. An additional option, the self-certification option, was never implemented. CMS is reconsidering the current Clinical Trial Policy (to be renamed the Clinical Research Policy) to address several issues that have surfaced since its implementation including the need to:

• Clarify payment criteria for clinical costs in research studies other than clinical trials;
• Devise a strategy to ensure that Medicare covered clinical studies are enrolled in the National Institute of Health (NIH) clinical trials registry website;
• Develop criteria to assure that any Medicare covered clinical research study includes a representative sample of Medicare beneficiaries, by demographic and clinical characteristics;
• Clarify the definitions of routine clinical care costs and investigational costs in clinical research studies including clinical trials;
• Remove the self-certification process that was never implemented;
• Clarify the scientific and technical roles of Federal agencies in overseeing IND Exempt trials;
• Determine if coverage of routine clinical care costs is warranted for studies beyond those covered by the current policy.
• Clarify how items/services that do not meet the requirements of 1862(a)(1)(A) but are of potential benefit can be covered in clinical research studies as an outcome of the National Coverage Determination process;
• Clarify whether and under what conditions an item/service non-covered nationally may be covered in the context of clinical research to elucidate the impact of the item or service on health outcomes in Medicare beneficiaries; and
• Discuss Medicare policy for payment of humanitarian use device (HUD) costs.

The CMS will convene its Medicare Coverage Advisory Committee (MCAC) on December 13, 2006 at the CMS Headquarters in Baltimore, Maryland. For more information on the Clinical Trial Policy, please visit the Coverage web site. 

V. WOMEN'S HEALTH

Outcome Of Dental Treatment During Pregnancy

In the US, more than one-half million, or about one in eight babies are born prematurely, i.e. before 37 weeks of pregnancy. Extremely preterm babies can be so small and underdeveloped that they must remain hospitalized for months, and, if they survive, spend years battling chronic health problems. Risk factors associated with premature births include smoking, low-income status, hypertension, diabetes, alcohol use, and genitourinary tract infections. However, since half of all preterm births occur without any clear explanation, there is strong motivation to reduce the estimated $26.2 billion annual cost for preterm births. Over the last two decades, data have been generated in observational studies that suggest periodontal disease during pregnancy might be one of those elusive risk factors. The theory is based on the idea that bacteria associated with periodontal disease may spread to the womb and help to induce preterm births. Dentists generally provide limited dental care to women only during the second trimester when the fetus has reached a more stable developmental stage and before treatment becomes too physically cumbersome for the mother. According to an article published in the New England Journal of Medicine (2006; 355:1885-1894), pregnant women who received non-surgical treatment for their periodontal, or gum, disease did not significantly lower their risk of delivering a premature or low-birthweight baby. These results come from the largest clinical trial to date to evaluate whether treating periodontal disease during pregnancy reduces a women's risk of early delivery. The study, called the Obstetrics and Periodontal Therapy Trial (OPT), also evaluated the safety of general dental care during pregnancy and found that dental treatment through the second trimester, both general and periodontal care, did not increase the number of adverse events for women during pregnancy. Launched in March 2003, OPT enrolled a total of 823 women with periodontal disease, all of whom were between 13 and 17 weeks pregnant upon entry into the study. Each woman was randomly assigned to receive either: (1) scaling and root planing of the teeth prior to the 21st week of pregnancy, then monthly tooth polishings or (2) scaling and root planing after delivery, meaning women in this group did not have their periodontal disease treated during their pregnancies. All women were 16 years or older and basic dental care was provided to everyone in the study. Results showed that preterm birth occurred in 12.0% in the treatment group (resulting in 44 live births) and in 12.8% in the control group (resulting in 38 live births). Although periodontal treatment improved periodontitis measures (P<0.001), it did not significantly alter the risk of preterm delivery (P=0.70; hazard ratio for treatment group vs. control group, 0.93). There were no significant differences between the treatment and control groups in birth weight (3239 g vs. 3258 g, P=0.64) or in the rate of delivery of infants that were small for gestational age (12.7% vs. 12.3%; odds ratio, 1.04). There were 5 spontaneous abortions or stillbirths in the treatment group, as compared with 14 in the control group (P=0.08). According to the authors, treatment of periodontitis in pregnant women improves periodontal disease and is safe but does not significantly alter rates of preterm birth, low birth weight, or fetal growth restriction.

VI. SPORTS MEDICINE

Tennis Elbow

According to an article published in the British Medical Journal (2006;333:939-941), a single blind randomized controlled trial study was performed to investigate the efficacy of physiotherapy compared with a wait and see approach or corticosteroid injections over 52 weeks in tennis elbow. The study included 198 subjects aged 18 to 65 years with a clinical diagnosis of tennis elbow of a minimum six weeks' duration. Also, non of the participants had active treatment by a health practitioner in the previous six months. Interventions included 1) eight sessions of physiotherapy; 3) corticosteroid injections; or wait and see. The main outcome measures were global improvement, grip force, and assessor's rating of severity measured at baseline, six weeks, and 52 weeks. Results showed that corticosteroid injection showed significantly better effects at six weeks but with high recurrence rates thereafter (47/65 of successes subsequently regressed) and significantly poorer outcomes in the long term compared with physiotherapy. Physiotherapy was superior to wait and see in the short term, while no difference was seen at 52 weeks, when most participants in both groups reported a successful outcome. Participants who had physiotherapy sought less additional treatment, such as non-steroidal anti-inflammatory drugs, than did participants who had wait and see or injections. According to the authors, physiotherapy combining elbow manipulation and exercise had a superior benefit to wait and see in the first six weeks and to corticosteroid injections after six weeks, providing a reasonable alternative to injections in the mid to long term. The significant short term benefits of corticosteroid injection are paradoxically reversed after six weeks, with high recurrence rates, implying that this treatment should be used with caution in the management of tennis elbow. 

VII. PSYCHOSOMATIC MEDICINE

Phobic Anxiety And Risk of Ventricular Arrhythmias

Findings of an association between phobic anxiety and elevated risks of sudden cardiac death suggest that phobic anxiety may be related to increased risk of ventricular arrhythmias. As a result, a study published in Psychosomatic Medicine (2006;68:651-656), was performed to examine whether phobic anxiety is associated with ventricular arrhythmias in patients with documented coronary artery disease (CAD). For the study, phobic anxiety level was measured using the Crown-Crisp phobic anxiety scale in 940 patients (660 men, 280 women) hospitalized for diagnostic cardiac catheterization between April 1999 and June 2002. Depressive symptomatology was assessed using the Beck Depression Inventory. Patients were followed for a median follow-up period of 3 years, and the occurrence of ventricular arrhythmias was determined through review of medical records. Results showed that ventricular arrhythmias occurred in 97 patients and were significantly related to higher phobic anxiety after statistical adjustment for established medical and demographic determinants of arrhythmias (odds ratio = 1.40; p = .012). Depressive symptomatology was significantly correlated with phobic anxiety (r = 0.44, p < .001) and was also related to ventricular arrhythmias (odds ratio = 1.40; p = .006). The composite of depression and phobic anxiety predicted ventricular arrhythmias with a larger effect size than either depression or phobic anxiety score alone (odds ratio = 1.6, p = .002). According to the authors, both phobic anxiety and depressive symptomatology predict ventricular arrhythmias in patients with CAD and may share a common factor predictive of ventricular arrhythmias.

VIII. 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.

How To Get FDA To Approve Illegally Marketed Drugs

The Federal Food, Drug, and Cosmetic Act generally requires that drugs marketed in the United States be shown to be safe and effective prior to marketing and widespread use in the general population. However, for a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally without required FDA approval. While some unapproved drugs may have benefits, there may also be risks. Drugs marketed without FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. In June 2006, FDA issued a revised Compliance Policy Guide (CPG), which makes clear that firms unlawfully marketing drugs need to submit applications showing that their products are safe and effective before continuing to market those products. Following the publication of the CPG (Section 440.100, "Marketed Unapproved Drugs"), many drug companies contacted FDA seeking clarification. The companies wanted information regarding how to obtain approval to legally market their currently unapproved drug products, and whether applications for marketing are subject to user fees, among other things. The FDA is committed to working with companies to facilitate the process of ensuring that products are safe and effective and meet appropriate standards for manufacturing and labeling. The FDA will hold a workshop on January 9, 2007, to provide information, clarification and guidance to sponsors seeking approval to legally market prescription and over-the-counter drugs through the New Drug Application (NDA), abbreviated New Drug Application (ANDA) and monograph processes. The workshop will be held from 9:00 AM until 4:00 PM in the Advisors and Consultants Staff conference room located at 5630 Fishers Lane, Rockville, Maryland. A notice announcing the meeting and giving registration details is expected to be published in the Federal Register on November 1, 2006. The agenda, when finalized, will be posted on FDA's web site.

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

IX. TARGET HEALTH

TARGET HEALTH INC. (www.targethealth.com) is a full service e*CRO 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.

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