On Target

ON TARGET
COMPLIMENTARY NEWS LETTER OF TARGET HEALTH® INC.

30 September 2007

I. WHAT'S NEW?
Drugs, Devices and Biologics - Target Health Presentation at RAPS
II. QUIZ - (Fill In The Blanks)
High Yield Fertilizer
III. HISTORY OF MEDICINE
Pick's Disease
IV. IMMUNOLOGY
Pneumonia Vaccine Highly Effective
V. CARDIOLOGY
Gender and Racial Bias in Cardiac Care
VI. NEUROLOGY
Statin Use and Post-Stroke Mortality
VII. REGULATORY AFFAIRS
Generics Are Radically Changing The Pharma Industry - We Need New Policies
VIII. TARGET HEALTH

I. WHAT'S NEW?

Drugs, Devices and Biologics - Target Health Presentation at RAPS

On September 25, 2007, Dr. Jules Mitchel of Target Health, together with Dr. Evan B. Siegel, of Ground Zero Pharmaceuticals Inc., and Dr. Miriam Provost, of M Squared Associates Inc.and former Deputy Director of the Office of Device Evaluation at CDRH (Device Division at FDA) presented talks at RAPS on the Differences in Clinical Trials for Drugs, Biologics and Devices. Dr. Mitchel featured his experience with 2 approved PMA products, one a drug/device combination and the second, a surgical cardiology device tested in the newborn. Drs Siegel and Provost shared their broad experience in drugs, biologics and drug development. Click here for the slide presentation.

For more information, please contact Dr. Jules T. Mitchel, Joyce Hays. Visit our Blog and Website. For new business opportunities, contact Adrian Pencak.

II. QUIZ (Fill In The Blanks)

High Yield Fertilizer

Researchers in Finland have just published results of a study showing that farmers can substitute human 1) ___ for conventional fertilizer and get a notable increase in cabbage yields. The research team at the University of Kuopio, grew cabbages using a conventional fertilizer, human urine that had been stored for 6 months, or no soil additive at all. In an upcoming issue of the Journal of Agricultural and Food Chemistry, the researchers report that the urine treatment yielded cabbages that were bigger and carried fewer 2) ___ than those grown by either other approach. Although the 3) ___ content of urine depends on what someone has eaten, analyses of the urine used in these experiments showed that its nitrogen, phosphorus, and potassium contents were comparable to those of 4) ___ fertilizer. Urine collected from one individual over the course of a year could fertilize a 90-square-meter plot, yielding more than 160 cabbages, the team calculates. The data indicate that a urine-treated plot would yield 64 kilograms more cabbage than one 5) ___ conventionally. Big cabbages appear to owe their superior growth to experimental fertilization with human urine. Earlier this year, the Kuopio scientists reported that cucumbers also benefit from the use of urine as fertilizer.

ANSWERS: 1) urine; 2) germs; 3) nutrient; 4) commercial; 5) fertilized

III. HISTORY OF MEDICINE

Pick's Disease

Because NM Senator Pete Dominici has had the misfortune to be diagnosed with Pick’s Disease, specifically one of the pathological subtypes of frontotemporal lobar degeneration (FTLD), we thought our readers might be interested in knowing more. Arnold Pick MD (1851 – 1924) was a Czechoslovakian neurologist and psychiatrist. He is known for identifying the clinical syndrome of Pick's Disease and the “Pick bodies” that are hallmark characteristic of the disorder. Pick bodies are spherical cytoplasmic inclusions found within neurons in affected portions of the brain. They cause neurons to swell, taking on a "ballooned" appearance. Pick bodies contain the protein Tau, and hence the disease is also referred to as a tauopathy (along with progressive supranuclear palsy, corticobasal degeneration, and others). Pick was the first to name reduplicative paramnesia, the delusional belief that a place or location has been duplicated. He was also the first to use the term dementia praecox (in 1891). Pick undertook extensive pathological studies of patients with neuropsychiatric diseases, and his work on the cortical localization of speech disturbances and other functions of the brain won him international acclaim. In addition to more than 350 publications, many of them on apraxia, of the ability to execute or carry out learned purposeful movements and agrammatism, the inability to speak in a grammatically correct fashion. Pick wrote a textbook on the pathology of the nervous system.

Pick’s Disease is a rare and fatal degenerative disease of the nervous system. It is characterized by signs of severe frontal or temporal lobe dysfunction, including loss of memory, disorientation, apathy, reduced initiative, lack of insight, and, in later stages, speech disorders, prominent grasp and sucking reflexes, and terminal decerebrate rigidity, dystonia (a movement disorder which causes involuntary contractions of muscles), and tremor. It usually occurs between the ages of 40 and 60, more often in women than in men. Course may take from a few months to 4 or 5 years to progress to complete loss of intellectual function. Death takes place 7-10 years after the onset of symptoms. It is due to atrophy of the frontal and temporal lobes. Clinically there are major overlaps with Alzheimer's presenile dementia. Some experts consider these diseases as one entity, and the term Pick-Alzheimer disease has been used. These are, however, two separate entities. Arnold Pick described progressive mental deterioration in a 71-year-old man. On autopsy, his brain showed unusual shrinkage of the frontal cortex. Cortex shrinkage is different from the anatomical changes in the brain associated with Alzheimer's disease. Compared with Alzheimer's disease, which accounts for 50 to 60% of dementia cases, Pick's disease accounts for about 5%. While average age of onset for Alzheimer's disease is about 50 years, Pick's disease may appear a decade earlier. Pick's disease is apparently hereditary and autosomal dominant inheritance has been reported.

IV. IMMUNOLOGY

Pneumonia Vaccine Highly Effective

Reliable estimates of the effectiveness of influenza vaccine among persons 65 years of age and older are important for informed vaccination policies and programs. As a result, a study published in the New England Journal of Medicine (2007;357:1373-1381), was performed to examine the effectiveness of influenza vaccine in seniors over the long term. For the study, data were pooled from 18 cohorts of community-dwelling elderly members of one U.S. health maintenance organization (HMO) for 1990–1991 through 1999–2000 and from two other HMOs for 1996–1997 through 1999–2000. Logistic regression was used to estimate the effectiveness of the vaccine for the prevention of hospitalization for pneumonia or influenza and death. There were 713,872 person-seasons of observation used for the analysis. Not unexpectedly, most high-risk medical conditions that were measured were more prevalent among vaccinated than among unvaccinated persons. Vaccination was associated with a 27% reduction in the risk of hospitalization for pneumonia or influenza and a 48% reduction in the risk of death. Estimates were generally stable across age and risk subgroups. It was concluded that during 10 seasons, influenza vaccination was associated with significant reductions in the risk of hospitalization for pneumonia or influenza and in the risk of death among community-dwelling elderly persons. The authors added that vaccine delivery to this high-priority group should be improved.

V. CARDIOLOGY

Gender and Racial Bias in Cardiac Care

Practice guidelines recommend implantable cardioverter-defibrillator (ICD) therapy for patients with heart failure and left ventricular ejection fraction of 30% or less. However, the influence of gender and race on ICD use among eligible patients is unknown. As a result, a study published in the Journal of the American Medical Association (2007;298:1525-1532), was performed to examine gender and racial differences in the use of ICD therapy. The study included an observational analysis of 13,034 patients participating in the American Heart Association's Get With the Guidelines–Heart Failure quality-improvement program. To be included in the analysis, patients had to be admitted to the hospital with heart failure, had to have left ventricular ejection fraction of 30% or less and be discharged alive from the hospital. Patients were treated between January 2005 and June 2007 at 217 participating hospitals. The main outcome measures were the use of ICD therapy or planned ICD therapy at discharge. Results showed that among patients eligible for ICD therapy, only 35.4% had ICD therapy at discharge (1614 with new ICDs, 527 with planned ICDs, and 2474 with prior ICDs). ICDs were used in 28.2% of eligible black women, 29.8% of white women, 33.4% of black men and 43.6% of white men (P < .001). After adjustment for patient characteristics and hospital factors, compared with white men, the adjusted odds of ICD use were 0.73 for black men, 0.62 for white women, and 0.56 for black women. The differences were not attributable to the proportions of women and black patients at participating hospitals or to differences in the reporting of left ventricular ejection fraction. Conclusions Less than 40% of potentially eligible patients hospitalized for heart failure received ICD therapy, and rates of use were lower among eligible women and black patients than among white men

VI. NEUROLOGY

Statin Use and Post-Stroke Mortality

The majority of patients with previous ischemic stroke are expected to benefit significantly from long-term statin therapy. However, discontinuation of medication therapy frequently occurs in clinical practice. As a result, a study published in the journal Stroke. 2007;38:2652-2657) was performed to assess the impact of discontinued statin therapy on clinical outcome in patients discharged after an acute ischemic stroke. The study population included 631 consecutive stroke survivors (322 men and 309 women; mean±SD age, 70.2±7.6 years) without clinical evidence of coronary heart disease. All patients were discharged on statin therapy and were followed up for 12 months after the acute ischemic stroke. Results showed that within 12 months from discharge, 246 patients ( 38.9%) discontinued statin therapy, with the mean time from discharge to statin discontinuation of 48.6±54.9 days. During follow-up, 116 patients died (1-year probability of death=0.18). Multivariate analysis demonstrated that after adjustment for all confounders and interactions, statin therapy discontinuation (hazard ratio= 2.78; P=0.003) was an independent predictor of all-cause 1-year mortality. According to the authors, a large number of patients discontinue their use of statins early after acute stroke and that patients discontinuing statins have a significantly increased mortality during the first year after the acute cerebrovascular event. The authors add that the findings suggest that patient care should be improved during the transition from a hospital setting to outpatient primary care.

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.

Generics Are Radically Changing The Pharma Industry - We Need New Policies

Generic drugs generally cost less than their brand-name counterparts and competition among generics has been a key factor in lowering drug prices. The FDA approved or tentatively approved a record of 682 generic drugs products in fiscal year 2007, over 30% more than the previous year. The FDA has recently announced a program aimed at increasing the number and variety of generic drug products available to consumers and health care providers. The Generic Initiative for Value and Efficiency, or GIVE, will help the FDA modernize and streamline its generic drug approval process. According to Gary Buehler, director of FDA's Office of Generic Drugs, "The GIVE plan outlines ways to maximize the use of our resources so that FDA can review and approve even more high quality generic drugs during the upcoming fiscal year than it did in 2007." As part of the GIVE efforts, FDA is revising the review order for certain drug applications. For example, first generic products, for which there are no blocking patents or exclusivity protections on the reference-listed drug, are identified at the time of submission for expedited review. This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster. Currently, FDA now has about 215 full-time staff working on the review of generic drug applications. Under GIVE, FDA will hire and train new generic drug reviewers and focus on enhanced use of electronic programs for handling drug submissions and internal documents. When possible, resources from other FDA departments will be engaged in the effort. As well, FDA will increase its communications with generic drug manufacturers and provide training on proper application submission to the industry in meetings and Webcasts. According to FDA, generic drugs undergo a rigorous scientific review to ensure that they are of high quality, safe, and effective. Generic drug manufacturers must demonstrate that a generic drug has the same dosage form, strength, route of administration, and conditions of use as the approved brand-name product. Generic drug manufacturers also must demonstrate bioequivalence, meaning they show that the drug delivers the same amount of its active ingredient in the same amount of time as the brand-name counterpart. Bioequivalence is a critical requirement for concluding that the original and generic drugs will produce the same therapeutic results. 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.

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