30 September 2007
I. WHAT'S NEW?
EDC and Drug Safety: 1) Experience in Vietnam and 2) A MedWatch Module
II. QUIZ - (Fill In The Blanks)
Attacking Melanoma In A New Way
III. HISTORY OF MEDICINE
Smallpox May Have Evolved 68,000 Years BP (Before Present)
IV. IMMUNOLOGY
Allergies and Asthma
V. WOMEN'S HEALTH
Oral Contraception and Cancer Risk
VI. PSYCHIATRY
Exercise and Depression
VII.
REGULATORY AFFAIRS
Highlights of the Food and Drug Administration Amendments Act of 2007
VIII. TARGET HEALTH
II. QUIZ
(Fill
In The Blanks)
Attacking Melanoma In A New Way
An experimental drug that attacks cancer in an entirely new way has shown promise in treating advanced melanoma, delaying progression of the disease and prolonging the 1) ___ of patients. New research presented September 26 at the European Cancer Conference in Barcelona found that giving the new drug in addition to 2) ___ more than doubled the amount of time patients survived without progression of their cancer. The drug is the first in a new class called 3) ____ ___ ____. It works by 4) ___ the amount of reactive oxygen species (ROS), such as hydrogen peroxide and superoxide, in cells. When the level exceeds the antioxidant capacity of cells, the cells are in a state of oxidative 5) ___. All cells have some low level of ROS, but cancer cells naturally operate with a 6) ___ level of ROS and oxidative stress relative to normal cells. However, too much oxidative stress for too long results in cell 7) ___. STA-4783 kills only tumor cells because the additional stress introduced pushes cancer cells, but not 8) ___ cells, over the critical threshold. 9) ___ is one of several cancer types that are known to operate at a higher level of oxidative stress. The concept of cancer cells operating at a higher level of oxidative stress than normal cells has been around for many years. However, it is only recently becoming a greater focus of attention in the field of 10) ___. Metastatic melanoma, where the skin cancer has spread to other parts of the body, is difficult to treat. Current therapies either have limited power or are highly 11) ___. The average survival of patients diagnosed with advanced melanoma is about six months. This study also indicated that STA-4783 might boost the efficiency of chemotherapy drugs that induce cell death, or 12) ___, because it appears to lower the hurdle for activating that process. These results are encouraging not only because of the findings, but also because there are so few treatment options for patients. STA-4783, appears to have the potential to improve survival with a manageable side effect profile. It is believed, there is nothing unique about metastatic melanoma and that oxidative stress has the potential to be an entirely new class of cancer treatment that could have applications in other types of cancer.IV. IMMUNOLOGY
Allergies and Asthma
It has long been debated whether people who develop asthma have a genetic propensity to develop allergies. As a result, a study published online (September 2007) in the Journal of Allergy and Clinical Immunology was performed to evaluate the relationship of asthma and allergies. The asthma cases studied were those attributed to atopy, a condition that results from gene-environment interactions and can be measured by a positive skin test to allergens (or allergy causing substances in the environment). Results showed that 56.3% of the current asthma cases in the country can be attributed to allergies, with approximately 30% of those cases attributed to cat allergy. The data come from 10,500 individuals participating in the Third National Health and Nutrition Examination Survey (NHANES III), a nationally representative sample of the population of the United States. While according to the authors, sensitization to cat appears to be a strong risk factor for asthma in this study, some research has showed that exposure to cats, particularly early in life, may be a protective factor. For the study, skin test data were observed for ten allergens. A positive skin test reaction to cat allergens accounted for 29.3% of the asthma cases, followed by the fungus Alternaria at 21.1% and white oak at 20.9%. Alternaria is a genus of ascomycete fungi. Alternaria species are known as major plant pathogens. They are also common allergens in humans, growing indoors and causing hay fever or hypersensitivity reactions that sometimes lead to asthma. Each of 10 allergen-specific skin tests was strongly associated with asthma; however, after adjustment by a variety of subject characteristics and all the allergens, only skin tests to cat, Alternaria and white oak were independently and positively associated with asthma. According to the authors, the study confirms that the environment plays a major role in the development of asthma, and if we can prevent, block or reverse atopy, we could reduce a large proportion of asthma cases. The authors are not advocating parents get rid of pets, but if you suspect that you or your child might have cat allergies or get asthmatic-like symptoms, you should consult with a physician about the best course of action for your family.V. WOMEN'S HEALTH
Oral Contraception and Cancer Risk
Since the introduction of oral contraception in the early 1960s, more than 300 million women are thought to have used it, often for prolonged periods and at a time of good health. Many studies have examined the potential association between oral contraception and cancer. The evidence suggests that current users of combined oral contraceptives have an increased risk of cancer of the breast, cervix, and liver compared with non-users, while the risks of breast and cervical cancer decline after stopping oral contraception, returning to that of non-users within about 10 years. To help clarify the relationship of oral contraception use and cancer incidence, a study published in the British Medical Journal (2007;335:651-654) was performed to examine the absolute risks or benefits on cancer associated with oral contraception, using incident data from the Royal College of General Practitioners' oral contraception study. The main outcome measures were the adjusted relative risks between never-users and ever-users of oral contraceptives for different types of cancer, main gynecological cancers combined, and any cancer. Covariates were age, smoking, parity, social class, and (for the general practitioner observation dataset) hormone replacement therapy. Subgroup analyses examined whether the relative risks changed with user characteristics, duration of oral contraception usage, and time since last use of oral contraception. The main dataset contained about 339,000 woman years of observation for never users and 744,000 woman years for ever users. Compared with never-users, ever-users had statistically significant lower rates of cancers of the large bowel or rectum, uterine body, and ovaries, tumors of unknown site, and other malignancies; main gynecological cancers combined; and any cancer. The relative risk for any cancer in the smaller general practitioner observation dataset was not significantly reduced. Statistically significant trends of increasing risk of cervical and central nervous system or pituitary cancer, and decreasing risk of uterine body and ovarian malignancies, were seen with increasing duration of oral contraceptive use. Reduced relative risk estimates were observed for ovarian and uterine body cancer many years after stopping oral contraception, although some were not statistically significant. The estimated absolute rate reduction of any cancer among ever users was 45 or 10 per 100,000 woman years, depending on whether the main or general practitioner observation dataset was used. According to the authors, in this UK cohort, oral contraception was not associated with an overall increased risk of cancer; indeed it may even produce a net public health gain. However, the authors added that the balance of cancer risks and benefits, however, may vary internationally, depending on patterns of oral contraception usage and the incidence of different cancers.VI. PSYCHIATRY
Exercise and Depression
The role of exercise training as a treatment for major depression is not known. As a result, a study published in Psychosomatic Medicine (2007;69:587-596) was performed to assess whether patients receiving aerobic exercise training performed either at home or in a supervised group setting, achieve reductions in depression comparable to standard antidepressant medication (sertraline) and placebo controls. For the study, a total of 202 adults (153 women; 49 men) diagnosed with major depression were assigned randomly to one of four conditions: 1) supervised exercise in a group setting; 2) home-based exercise; 3) antidepressant medication (sertraline, 50–200 mg daily); or 4) placebo pill for 16 weeks. Patients underwent the structured clinical interview for depression and completed the Hamilton Depression Rating Scale (HAM-D). Results showed that after 4 months of treatment, 41% of the participants achieved remission, defined as no longer meeting the criteria for major depressive disorder (MDD) and a HAM-D score of <8. Patients receiving active treatments tended to have higher remission rates than the placebo controls: supervised exercise = 45%; home-based exercise = 40%; medication = 47%; placebo = 31% (p = .057). All treatment groups had lower HAM-D scores after treatment, and scores for the active treatment groups were not significantly different from the placebo group (p = .23). The authors concluded that the efficacy of exercise in patients seems generally comparable with patients receiving antidepressant medication and both tend to be better than the placebo in patients with MDD. However, placebo response rates were high, suggesting that a considerable portion of the therapeutic response is determined by patient expectations, ongoing symptom monitoring, attention, and other nonspecific factors.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.Highlights of the Food and Drug Administration Amendments Act of 2007
On September 20, 2007, in a 405-7 vote, the U.S. House passed legislation reauthorizing PDUFA. The following are highlights of the law: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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