Dean Gittleman Joins Target Health as Senior Director of Operations

 

 

As part of its continuing growth, Target Health is pleased to announce that Dean Gittleman has joined Target Health as Senior Director of Operations. Dean comes with a broad background in Clinical Data Management, Biometrics, and Clinical and Scientific Computing, in both large and small Pharma/Biotech organizations, Medical Devices, and in CROs. Previous companies include Pfizer, ICOS, Eisai and Vertex. Dean’s responsibilities include process optimization within the company, strategic planning for the growth of Target Health, and working cross-functionally across the development and corporate organizations.

 

Dean will report to Jules T. Mitchel, President of Target Health, and Joyce Hays,CEO of Target Health, and will work closely with Yong Joong Kim who runs our data management, application development and software development groups, Joonhyuk Choi, who is responsible for software and application development, and Glen Park who runs our clinical and regulatory operations. Laura Suciu, Director of QA will report to Dean.

 

Dean is a Rutgers graduate with a major in Biology, and earned a Masters of Science in Management Information Systems from Fairleigh Dickinson University.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com

Women’s Heart Disease Tied to Small Blood Vessels

 

 

 

 

Heart disease affects men and women in different ways. In women, symptoms of burgeoning heart disease are often more insidious, but when a heart attack strikes, it is more lethal than it is in 1) ___. Roughly 25% of men will die within a year of their first heart attack, but among women, 38% will die. Women are twice as likely as men to have a second heart attack within 6 years of their first one, and women are twice as likely as men to die after bypass surgery. Yet after a heart attack, women’s hearts are more likely to maintain their systolic function — their ability to contract and pump 2) ___ from the chambers into the arteries. According to C. Noel Bairey Merz, MD, Director of the Women’s Heart Center at Cedars-Sinai Heart Institute in Los Angeles, this suggests that heart disease manifests differently in women, affecting the microvasculature (small blood vessels) instead of the 3) ___ (major blood vessels) as it does in men.

 

Dr. Bairey Merz provided an overview of the gender differences in heart disease at the Physiology of Cardiovascular Disease: Gender Disparities conference, October 12-14 at the University of Mississippi in Jackson. The conference is sponsored by the American Physiological Society with additional support from the American Heart Association.

 

Function Indicates Form

 

The heart is a 4) ___, and as with other muscles, depriving it of oxygen causes damage that diminishes its ability to function. Conventional wisdom notes that the most prevalent form of heart disease is coronary artery disease, in which atherosclerotic plaque narrows and eventually blocks the major arteries leading into the heart, thus cutting off the heart’s supply of 5) ___. The damage to the heart tends to be permanent, and after a heart attack, the heart never quite regains its former power. But when reviewing the medical literature, Dr. Bairey Merz and her colleagues found that women’s hearts were less likely than men’s to lose their ability to 6) ___ blood after a heart attack, and that female heart patients were less likely to present with obstructive coronary artery disease. Instead, the oxygen deprivation and subsequent damage to the heart is more likely to occur when small blood 7) ___, not major arteries, become dysfunctional.

 

“That is the reason women are often misdiagnosed and suffer adverse events,” said Dr. Bairey Merz. “Physicians have been looking for male pattern disease, when we need to start looking at 8) ___ patterns.” Likewise, more research is needed to develop appropriate treatments and reduce risk in women, she added. According to Dr. Bairey Merz, the good news is that it is possible to measure damage to 9) ___ blood vessels objectively. “The gold standard is reactivity testing, angiograms, and other physiologic measures, rather than anatomic study.”

 

Dr. Bairey Merz provided an overview of the latest data about these methods and how they can be applied to help clinicians understand gender differences in the pathophysiology of 10) ___ disease during her presentation.

 

ANSWERS: 1) men; 2) blood; 3) macrovasculature; 4) muscle; 5) oxygen; 6) pump; 7) vessels; 8) female; 9) small; 10) heart

Native Voices: Native Peoples’ Concepts of Health and Illness

 

A petroglyph (Lithic stage) of a caravan of bighorn sheep near Moab, Utah

 

 

In the sequence of North American prehistoric cultural stages first proposed by Gordon Willey and Philip Phillips in 1958, the Lithic stage was the earliest period of human occupation in the Americas, accruing during the Late Pleistocene period, to time before 8,000 BCE (before 10,000 years ago). The stage derived its name from the first appearance of Lithic flaked stone tools.

 

The time encompasses the Paleo-Indian period that subsequently is divided into more specific time terms such as Early Lithic stage or Early Paleo-Indians and Middle Paleo-Indians or Middle Lithic stage. Examples include the Clovis culture and Folsom tradition groups. Medical evidence suggests big-game hunters crossed the Bering Strait from Asia (Eurasia) into North America over a land bridge (Beringia), that existed between 45,000 BCE – 12,000 BCE (47,000 – 14,000 years ago).Small isolated groups of hunter-gatherers migrated alongside herds of large herbivores. Ice-free corridors allowed animals, followed by humans, to migrate south into the interior.

 

Through medical and scientific research, peoples of the Americas have been linked to North Asian populations by linguistic factors, the distribution of blood types, and in genetic composition as reflected by molecular data, such as DNA.Between 8000 BCE – 7000 BCE (10,000 – 9,000 years ago) the climate stabilized, leading to a rise in population and lithic technology advances, resulting in a more sedentary lifestyle.

 

In October 2011, a new exhibition examining concepts of health and medicine among contemporary American Indians, Alaska Natives, and Native Hawaiians, is opening at the National Library of Medicine, part of the National Institutes of Health. Native Voices: Native Peoples’ Concepts of Health and Illness, explores the connection between wellness, illness, and cultural life through a combination of interviews with Native people, artwork, objects, and interactive media. Opening events were held on October 5, 2011 and included ceremonial dancing and the blessing of a healing totem pole that was created for the exhibition and installed in front of the Library.

 

The National Library of Medicine has a history of working with Native communities as part of the Library’s commitment to make health information resources accessible to people no matter where they live or work. The Native Voices exhibition concept grew out of meetings with Native leaders in Alaska, Hawaii and the contiguous United States. “This exhibition honors the Native tradition of oral history and establishes a unique collection of information,” says Donald A.B. Lindberg, MD, director of the National Library of Medicine. “We hope visitors will find Native Voices educational and inspirational, and we hope Native people will view it with pride. The Library is excited to open this exhibition, and to do it during our 175th anniversary year.”

 

Topics featured in the exhibition include: Native views of land, food, community, earth/nature, and spirituality as they relate to Native health; the relationship between traditional healing and Western medicine in Native communities; economic and cultural issues that affect the health of Native communities; efforts by Native communities to improve health conditions; and the role of Native Americans in military service and healing support for returning Native veterans.

 

In addition to the collection of interviews, here are some of the objects visitors will find in the exhibition:

 

  • In the lobby of the Library, guiding people into the exhibition, is a 10-foot model of the Hokule’a, a traditional Hawaiian voyaging canoe used for long-distance travel. Visitors will learn how the mission of the Hokule’a has spurred a Hawaiian cultural and health revival.
  • Inside the exhibition, in a section that explores Native games for survival, strength and sports, visitors will find a vintage surfboard and learn about Native Hawaiian sportsman Duke Kahanamoku, who won Olympic medals in swimming and revived the sport of surfboarding.
  • Ceremonial drums, pipes, and rattles from the Upper Plains Indians grace a section on healing.
  • A World War II radio is one object that helps tell the story of Navajo and other American Indian Code Talkers. Visitors will learn about their service to the country and the ceremonies performed by traditional healers to help relieve combat-related stress experienced by returning veterans.
  • The 20-foot healing totem pole created by master carver Jewell Praying Wolf James and the House of Tears Carvers of the Lummi Nation in the Pacific Northwest is located in the herb garden in front of the Library. Visitors will discover the meaning of the stories, symbols and colors on the totem pole and two benches that accompany it. In the weeks preceding the exhibition opening, the totem received blessings from a number of tribes as it was transported across the country to be permanently installed at the Library. Previous work by carver Jewell James includes healing totems to honor the victims of the September 11th attacks. Those totems are now installed in Arrow Park in New York, in Shanksville, Pennsylvania and at the Congressional Cemetery in Washington, DC.

Experimental Vaccine Protects Monkeys From Blinding Trachoma

 

 

The Centers for Disease Control and Prevention received more than 1.2 million reports of Chlamydia infections in 2009. Chlamydia diseases include STD infections, which can result in pelvic inflammatory disease that can cause infertility in women, as well as trachoma. If left untreated, prolonged trachoma infection can cause a person’s eyelids to fold inward, so that the eyelashes rub the eyeball and scar the cornea. This can result in impaired vision and sometimes blindness. Trachoma is treatable with antibiotics, although in many parts of the world people have limited access to treatment. Currently, there is no vaccine for trachoma. Trachoma experts estimate that approximately 1.3 million people are blind from trachoma, 1.8 million people have low vision as a result of the disease, and an estimated 40 million people have active trachoma. Trachoma is most often spread through direct personal contact, shared towels and other cloths, and flies that have come in contact with the eyes or nose of an infected person.

 

According to an article published online in The Journal of Experimental Medicine (10 October 2011), an attenuated, or weakened, strain of Chlamydia trachomatis bacteria has been used as a vaccine to prevent or reduce the severity of trachoma, the world’s leading cause of infectious blindness. According to the NIH, this work is an important milestone in the development of a trachoma vaccine, and if this approach demonstrates continued success, the implications could be enormous for the tens of millions of people affected by trachoma, a neglected disease of poverty primarily seen in Asia and sub-Saharan Africa.”

 

The vaccine concept was tested in a series of experiments. First six cynomolgus macaques were infected with the strain of C. trachomatis that was weakened by removing a small piece of DNA. Results showed that the monkeys spontaneously cleared the infection within 14 days with no or minimal signs of ocular disease. The animals then were exposed twice more to the weakened strain at four- and eight-week intervals, but the animals still showed no signs of trachoma despite being infected and they all mounted robust immune responses. According to the authors, this finding is particularly significant because repeated C. trachomatis infections typically lead to more severe eye disease in people.

 

The same six macaques then were exposed to a highly virulent strain of C. trachomatis as were six other macaques in a control group that had not been vaccinated. Three of the macaques in the vaccine group showed no signs of infection or disease, and the three others showed greatly reduced infection compared with monkeys in the control group. All six macaques in the control group became infected and displayed moderate to severe eye disease that persisted for between two and four months.

 

Macaques are used in trachoma studies because their immune responses closely predict those of humans. The animals in the study were treated with antibiotics after completion of the experiments, and all recovered completely.

 

According to the authors, findings from this study also could also lead to the development of a vaccine against Chlamydia infections.

Premorbid Statin Use is Associated with Improved Survival and Functional Outcomes in Older Head-Injured Individuals

 

 

According to an article published in the Journal of Trauma-Injury Infection & Critical Care (2011;71:815-819), a study was performed to determine whether pre-injury statin use is associated with survival and functional recovery in older adult victims of moderate/severe head trauma.

 

The study used the National Study of Costs and Outcomes of Trauma dataset compiled from 69 US hospitals, to assess the effect of pre-injury statin use for in-hospital mortality and functional outcome in patients aged >65 with head injury Abbreviated Injury Score (AIS) >3. Individuals dying within 24 hours of admission or presenting with fixed dilated pupils were excluded. The Extended Glasgow Outcome Scale, dichotomized at the ability to return to premorbid major activity, was used to measure functional outcome. Multivariate regression modeled statin use and outcomes controlling for demographic, comorbidity, and injury characteristics.

 

Results showed that of the 523 eligible individuals, 117 (22%) used statins at the time of injury. Statin use was associated with a 76% lower adjusted risk of in-hospital death (relative risk [RR] = 0.24). Of 395 individuals discharged alive, 303 survived 1 year and 264 had complete Extended Glasgow Outcome Scale scores. Statin users and nonusers demonstrated similar risk of good recovery at 3 months (RR = 0.83). At 12 months post-injury, statin users had 13% higher likelihood of good recovery (RR = 1.13). However, the presence of cardiovascular comorbidities abrogated this effect.

 

According to the authors, re-injury statin use in older adult traumatic brain injury victims is associated with reduced risk of death and improved functional recovery at 12 months post-injury. Individuals with cardiovascular comorbidities lose this benefit of premorbid statin use. Statins, as possible protective agents in head trauma, warrant further study.

Inefficient Developing World Stoves Contribute to 2 Million Deaths a Year

 

According to experts from the National Institutes of Health, an international effort to replace smoky, inefficient household stoves that people commonly use in lower and middle income countries with clean, affordable, fuel efficient stoves could save nearly 2 million lives each year. In a commentary in Science magazine (October 2011), the authors noted that indoor air pollution from such inefficient stoves affects about 3 billion people-nearly half the world’s population. In addition to respiratory disease caused by smoke, the fuel needed by inefficient stoves leads to -deforestation, and environmental degradation.

 

Women and children are at greatest risk for the adverse health effects posed by inefficient stoves. Men tend to leave home during the day, but women and children remain. As a result, women and children have many of the same disease risks as do people who smoke tobacco. These risks include pneumonia, lung cancer and chronic obstructive pulmonary disease.

 

In many societies, women and girls typically gather fuel for the stoves. Fuel gathering is time-consuming and, because they must often walk several miles from the safety of their home communities, these women and girls are at increased risk for gender-based violence.

 

The study authors cited a recent report by the World Bank, which noted that, in addition to improving public health, clean, efficient stoves could have benefits to the environment and the climate, by reducing carbon dioxide emissions. In recognition of the problem, the United Nations launched the Global Alliance for Clean Cookstoves. A public-private partnership, the alliance seeks to create a global market for clean and efficient cookstoves and fuels in the developing world. The alliance’s target is “100 by 20,” which stands for the adoption of clean, efficient stoves and fuels by 100 million homes by the year 2020, with eventual worldwide adoption. The authors noted that the U.S. government has committed more than $50 million to the effort, including about $25 million in research funds for the NIH.

 

Educating people about the health risks of the stoves would also increase demand, as potential users understand that the initial expense of a more efficient stove would have health benefits in the long run. Governmental subsidies to help the poorest people purchase the stoves would provide additional incentive, as would efforts to informal local peoples that the new stoves would cut household fuel costs. The authors called for more research on the potential health benefits of cleaner, more efficient stoves. It is not precisely known how much emissions must be reduced to produce health benefits. For example, preliminary data from one study suggest that reducing exposure to emissions by 90% is needed to substantially reduce the risk of pneumonia, and reducing exposure by 50% is required to modestly reduce the risk. Similarly, such studies could confirm the link between indoor air pollution and suspected health risks such as low birth weight, cataracts, cardiovascular disease, asthma, and tuberculosis.

 

The estimated the costs of a research program to on health and indoor air pollution to range from $150 million to $200 million.

TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.

 

 

FDA, CMS Launch Pilot Program for Voluntary Parallel Review of Innovative Devices

 

Often, device sponsors focus solely on obtaining FDA approval, only to find that Medicare coverage is not automatically forthcoming. Both agencies rely on clinical data in reaching their decisions, and while the two agencies have distinctly different regulatory responsibilities, parallel review can reduce time between FDA approval and Medicare national coverage determinations.

 

The FDA and the Centers for Medicare & Medicaid Services (CMS) today launched a “parallel review” pilot program for concurrent review of medical devices for FDA approval and Medicare coverage. The FDA and CMS, which will begin accepting submissions today, issued procedures for voluntary participation and guiding principles that the agencies will follow during product review. The FDA and CMS anticipate that parallel review will facilitate the development of innovative new products and increase the efficiency of the review processes for both agencies.

 

The pilot program, announced in a Federal Register notice posted for advanced viewing today, is voluntary and will not change the existing separate and distinct review standards for FDA device approval and CMS coverage determination. It is only available for qualifying new medical device technologies. The Federal Register notice also outlines the agencies’ commitment to ensuring that submitted data is confidential and highlights when sponsors can opt-out of the parallel review program.

 

The pilot program, which will last for up to two years with the possibility for extension, will focus on innovative technologies that can benefit from the efficiencies of parallel review. The pilot program will accept no more than three to five submissions per year.

 

In September 2010, the FDA and CMS announced their intention to implement a parallel review process, and received 37 public comments, which can be found in the public docket.

 

For more information and to read the Federal Register notice: FDA-CMS Premarket Review; Medicare Coverage Center