2nd eSource Direct Data Entry Clinical Trial Completed Under a US IND



Target Health is pleased to announce that it has completed its second direct data entry (sSource) clinical trial under a US IND, using Target e*CRF® and Target e*CTR® (eClinical Trial Record).


Full enrollment will occur in a 3rd study within a month in a 6 center study with 120 randomized patients. Congratulations to a long list of the industry’s best career professionals, who happen to be permanently employed at Target Health Inc., for the following major accomplishments:


1.  The sites are very “happy” and asked us, “what has taken the Industry so long?”

2.  Monitoring visits dropped by 50%

3.  No protocol violations, as we performed daily central monitoring

4.  Only 3% of forms queried, and of these a total of less than 1% of forms were changed

5.  Site saved 70 hours of administrative time as they only entered the data once

6.  75% of all forms reviewed within the same day of the office visit


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


New York Hospitals Look to Combine, Forming a Giant



Will this hospital mega-merger make healthcare more or less 1) ___ for the average New Yorker?


Two of New York City’s biggest hospital systems reached agreement last Wednesday to pursue a merger that would shake up the way 2) ___ care is delivered, especially in Manhattan, where hospitals compete to serve some of the wealthiest neighborhoods in the world. The proposed merger would bring together NYU Langone Medical Center, a highly specialized academic medical center, and Continuum Health Partners, a network of several community-oriented hospitals, including Beth Israel and the two St. Luke’s-Roosevelt campuses. It would create one of the largest healthcare systems in the city, one that would have immense market power under the new 3) ___ health care system, and put pressure on independent medical practices, insurance companies and even rival medical schools, which may have to find other places to train their students.


The deal was outlined in a memorandum of understanding approved on Tuesday and Wednesday by the boards of both nonprofit organizations, and it is still subject to final confirmation by the boards. It would also need regulatory approval, and at least one patient advocacy group promised to challenge it. By strengthening its competitive advantage, a merged hospital system could limit options for 4) ___ and charge more for services, advocates fear. It would also have more power to negotiate higher rates with insurance companies, which might be passed on to consumers in the form of higher 5) ___.


The proposed merger comes amid a wave of health care consolidations around the country, driven by shrinking reimbursements from insurers and the government and by mandates of the federal health care law to operate more efficiently and at lower 6) ___. Hospitals are combining with other hospitals, doctor’s offices and even insurance companies as payment models shift from fee-for-service to a per-person rate in which providers are expected to manage most of a patient’s care, requiring coordination among doctors and facilities. “Economists have for some time now worried about the ceaseless consolidation on the supply side of the health care market, facing a much more splintered payment side with less market power,” Uwe E. Reinhardt, a health economist at Princeton University, said Wednesday.


The memorandum of understanding is essentially an agreement to share proprietary information, including financial, technology and personnel data, that would be needed to make a final decision to merge, most likely within six months. It is not binding, but it is a signal, as one hospital official said, that the proposal has gone beyond courtship to the engagement stage. In a joint statement on Wednesday evening, the boards said they would explore how their partnership “could create a fully integrated 7) ___ delivery system for the benefit of the people they serve, including underserved populations.” “Both entities expect,” it added, “that a successful partnership would achieve economies of scale that reduce health care costs while enhancing the 8) ___ of care and allowing for investment in new facilities.”


Any merger would have to be reviewed by the Federal Trade Commission, which would consider any antitrust implications, as well as by the State Health Department and the State Dormitory Authority, a financing and construction agency that carries some debt for Continuum. At least one trustee suggested that the 9) ___ would argue that their market share should be looked at in the context of New York City as a whole — perhaps even the nation — and not just Manhattan. “You have to be competitive,” the trustee said, speaking on the condition of anonymity because, he said, any public comment would be scrutinized by the regulatory agencies. “More and more of the reimbursement is going to be tied to lowering your costs, not raising your costs.”


The new organization would capture a huge swath of Manhattan, including some of its most affluent neighborhoods. It would be a formidable rival in the fight for patients and market share with the current behemoth among New York City hospital systems, New York-Presbyterian, which was created by a 1998 merger of what are now known as Columbia University and Weill Cornell Medical Centers. The hospital with perhaps the most to lose would be Mount Sinai Medical Center, like NYU an 10) ___ medical center, which would be geographically sandwiched between the two chains.


Officials said it was premature to predict that New York University Medical School would expand, but the merger could open up more hospital training slots for NYU medical students and cause Continuum’s current affiliates – Columbia University College of Physicians and Surgeons, Albert Einstein College of Medicine and New York Medical College – to lose some. Mergers often lead to the elimination of some specialty services that are 11) ___ among the combining hospitals. But officials at the hospitals, who spoke on the condition of anonymity because of confidentiality agreements, said the two organizations would deliver services more efficiently and would complement each other. They would bring in patients with a wider variety of ailments than either hospital does now.


But patient advocates may resist such a powerhouse. “That’s really too bad,” Judy Wessler, director of the Commission on the Public’s Health System, said of the decision to move forward. She said her group would ask regulators to reject the merger. Nisha Agarwal, deputy director of the Center for Popular Democracy, an advocacy group for low-income people, said she was “concerned about the antitrust implications and the impact on consumers,” but was not yet sure whether her group would file a legal challenge. Dr. Reinhardt said that while hospitals talked about synergy and public interest, the biggest impact of such a merger would be to give them more leverage with 12) ___ companies. But the insurance side has also been consolidating, he said, leading to a tug of war with hospitals. “So a hospital can literally tell an insurer you either take our prices or you take a walk, and that’s what’s happening,” he said. “Both sides always justify that, not on the basis of crude market power – we want more market power to get better prices – they always find some kind of high national purpose.”



ANSWERS: 1) expensive; 2) medical; 3) federal; 4) patients; 5) premiums; 6) cost; 7) healthcare; 8) quality; 9) hospitals; 10) academic; 11) duplicated; 12) insurance

Beth Israel Medical Center, Manhattan


Dazian Pavilion of the Petrie Division of Beth Israel Medical Center as seen from Stuyvesant Square in Manhattan



Beth Israel was incorporated in 1890 by a group of 40 Orthodox Jews on the Lower East Side each of whom paid 25 cents to set up a hospital serving New York’s Jewish immigrants, particularly newcomers. At the time New York’s hospitals would not treat patients who had been in the city less than a year. It initially opened a dispensary on the Lower East Side. In 1891 it opened a 20-bed hospital and in 1892 expanded again and moved into a 115-bed hospital in 1902.


In 1929 it moved into a 13-story, 500-bed building at its current location at the corner of Stuyvesant Square. It purchased its neighbor the Manhattan General Hospital in 1964 and renamed the complex Beth Israel Medical Center, located at First Avenue and 16th Street in Manhattan. By the 1980s it had long extended beyond its Jewish base. In 1988 it had the largest network of heroin-treatment clinics in the United States with 7,500 patients and 23 facilities. It acquired Doctors Hospital on the Upper East Side in the 1990s, renaming it Beth Israel Medical Center-Singer Division, and Kings Highway Hospital Center in 1995, renaming it Beth Israel Medical Center-Kings Highway Division.


In 2004, Beth Israel Medical Center closed the Singer Division and consolidated its Manhattan inpatient operations at the main hospital campus, called the Petrie Division, on First Avenue at 16th Street in Manhattan. As of 2010 Beth Israel Medical Center has residency training programs in nearly every major field of medicine including: Emergency Medicine, Internal Medicine, Surgery, ENT, Oral Maxillo-Facial Surgery, Radiology, Family Medicine, Dermatology, Obstetrics and Gynecology, Neurology, Ophthalmology, Pathology, Psychiatry, Podiatry, and Urology. Continuum Health Partners which owns Beth Israel provides resident trainees with subsidized housing and a competitive salary. In 2011 Huguette Clark died at the hospital at age 104. She left one million dollars to the hospital upon her death.


Huguette Marcelle Clark (June 9, 1906 – May 24, 2011) was an American heiress and philanthropist, who grew up in the 122 room mansion at Fifth Avenue and 77th Street, shown below.


Huguette M. Clark



The youngest daughter of former United States Senator and industrialist William A. Clark, she lived a reclusive life after 1930 and her activities were virtually unknown to the public. Upon her death in 2011, Clark left behind a vast fortune, most of which was donated to charity. Substantial sums were also left to her longtime nurse, her goddaughter, some employees and her attorney. Her accountant and her attorney are part of a criminal investigation concerning suspicions of mishandling Clark’s assets. Clark died at Beth Israel Medical Center, in New York City, two weeks short of her 105th birthday.


In recent years her eyesight had failed and her hearing was weak, and at times she had been unwilling to eat. She was moved in mid-April from her private room at Beth Israel Medical Center in New York up to its medical intensive care unit, then in mid-May to a room with hospice care. She had been living at the hospital under pseudonyms – the latest was Harriet Chase – in a guarded room with full-time private nurses. Her hospital room number didn’t even exist – outside her room on the 3rd floor, a card with the fake room number “1B” and the name “Chase” was taped over the actual room number. When she was moved to intensive care, room 1B was cleared of her belongings, and the card was removed. Huguette Clark has been almost entirely alone, aside from her private nurse and occasional visits by her accountant. One of her former attorneys represented her for 20 years without meeting her face to face, instead talking through a closed door. By all accounts of sound body and mind till nearly the end of her life, Mrs. Clark had lived, apparently by choice, cloistered in New York hospitals since the late 1980s. There, first in Doctors Hospital and later at Beth Israel, she was reported to have lived under a series of pseudonyms. The most recent, was Harriet Chase. In the hospitals, Mrs. Clark, whose given name is pronounced hyoo-GETT, was attended by round-the-clock private aides and surrounded by the fine French dolls she had collected since she was a girl. The collection was worth millions of dollars.


Even though Mrs. Clark had stunning Central Park views from 3 separate residences she owned at 907 Fifth Avenue, totaling 42 rooms, as well as multimillion-dollar estates in Connecticut and California, she chose to live her last many years in a hospital room at Beth Israel Medical Center. She was entombed on the morning of May 26, 2011, in the family mausoleum in section 85 of Woodlawn Cemetery, located in The Bronx, borough of New York City.


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Odds of Quitting Smoking Affected By Genetics



Sometimes we need to help people in spite of themselves. The reason is that unhealthy habits of individuals can affect the health of many others, which takes its toll not only on the health of each of us, but costs all of us more dollars in healthcare (editor’s note).


According to the Centers for Disease Control and Prevention, tobacco use is still the single most preventable cause of disease, disability, and death in the United States. Smoking or exposure to secondhand smoke results in more than 440,000 preventable deaths each year – about 1 in 5 U.S. deaths overall. Another 8.6 million live with a serious illness caused by smoking. Despite these well-documented health costs, over 46 million U.S. adults continue to smoke cigarettes.


According to an article published online in the American Journal of Psychiatry (30 May 2012), genetics can help determine whether a person is likely to quit smoking on his or her own or need medication to improve the chances of success. According to the authors, the study moves health care providers a step closer to one day providing more individualized treatment plans to help patients quit smoking.


The current study focused on specific variations in a cluster of nicotinic receptor genes, CHRNA5-CHRNA3-CHRNB4, which prior studies have shown to contribute to nicotine dependence and heavy smoking. Using data obtained from a previous study supported by the National Heart Lung and Blood Institute, it was shown that individuals carrying the high-risk form of this gene cluster reported a 2-year delay in the median quit age compared to those with the low-risk genes. This delay was attributable to a pattern of heavier smoking among those with the high risk gene cluster.


The authors then conducted a clinical trial, which confirmed that persons with the high-risk genes were more likely to fail in their quit attempts compared to those with the low-risk genes when treated with placebo. However, medications approved for nicotine cessation (such as nicotine replacement therapies or bupropion) increased the likelihood of abstinence in the high risk groups. Those with the highest risk had a three-fold increase in their odds of being abstinent at the end of active treatment compared to placebo, indicating that these medications may be particularly beneficial for this population.


According to the authors, it was found that the effects of smoking cessation medications depend on a person’s genes, and if smokers have the risk genes, they don’t quit easily on their own and will benefit greatly from the medications. The authors added that if smokers don’t have the risk genes, they are likely to quit successfully without the help of medications such as nicotine replacement or bupropion.


Go to the following websites for information on tobacco addiction, and tools and resources to help quit smoking.


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Childhood CT Scans Linked to Leukemia and Brain Cancer Later in Life



CT scans deliver a dose of ionizing radiation to the body part being scanned and to nearby tissues. Even at relatively low doses, ionizing radiation can break the chemical bonds in DNA, causing damage to genes that may increase a person’s risk of developing cancer. Children typically face a higher risk of cancer from ionizing radiation exposure than do adults exposed to similar doses.


According to an article published online in The Lancet (7 June 2012), children and young adults scanned multiple times by computed tomography (CT), a commonly used diagnostic tool, have a small increased risk of leukemia and brain tumors in the decade following their first scan. These findings are from a study of more than 175,000 children and young adults that was led by researchers at the National Cancer Institute (NCI), part of the National Institutes of Health, and at the Institute of Health and Society, Newcastle University, England. However, the authors do emphasize that when a child suffers a major head injury or develops a life-threatening illness, the benefits of clinically appropriate CT scans should outweigh future cancer risks.


Despite the elevation in cancer risk, the two malignancies (leukemia and brain tumors ) are relatively rare and the actual number of additional cases caused by radiation exposure from CT scans is small. The most recent (2009) U.S. annual cancer incidence rates for children from birth through age 21 for leukemia and brain and other nervous system cancers are 4.3 per 100,000 and 2.9 per 100,000, respectively. The investigators estimate that for every 10,000 head CT scans performed on children 10 years of age or younger, one case of leukemia and one brain tumor would occur in the decade following the first CT beyond what would have been expected had no CT scans been performed.


The investigators obtained CT examination records from radiology departments in hospitals across Britain and linked them to data on cancer diagnoses and deaths. The study included people who underwent CT scans at British National Health Service hospitals from birth to 22 years of age between 1985 and 2002. Information on cancer incidence and mortality from 1985 through 2008 was obtained from the National Health Service Central Registry, a national database of cancer registrations, deaths and emigrations.


Approximately 60% of the CT scans were of the head, with similar proportions in males and females. The investigators estimated cumulative doses from the CT scans received by each patient, and assessed the subsequent cancer risk for an average of 10 years after the first CT. A clear relationship was found between the increase in cancer risk and increasing cumulative dose of radiation. A three-fold increase in the risk of brain tumors appeared following a cumulative absorbed dose to the head of 50 to 60 milligray (abbreviated mGy, which is a unit of estimated absorbed dose of ionizing radiation). Similarly, a three-fold increase in the risk of leukemia appeared after the same dose to bone marrow (the part of the body responsible for generating blood cells). The comparison group consisted of individuals who had cumulative doses of less than 5 mGy to the relevant regions of the body.


The absorbed dose from a CT scan depends on factors including age at exposure, gender, examination type, and year of scan. Broadly speaking, two or three CT scans of the head using current scanner settings would be required to yield a dose of 50 to 60 mGy to the brain. The same dose to bone marrow would be produced by five to 10 head CT scans, using current scanner settings for children under age 15.


In countries like the United States and Britain, the use of CT scans in children and adults has increased rapidly since their introduction 30 years ago. Due to efforts by medical societies, government regulators, and CT manufacturers, scans performed on young children in 2012 can have 50% lower radiation doses, compared to scans carried out in the 1980s and 1990s. However, the amount of radiation delivered during a single CT scan can still vary greatly and is often up to 10 times higher than that delivered in a conventional X-ray procedure.

Structural Brain Abnormalities in Adolescent Anorexia Nervosa Before and After Weight Recovery and Associated Hormonal Changes



The neurobiological mechanisms of structural brain abnormalities in patients with anorexia nervosa (AN) remain poorly understood. In particular, little is known about the changes in and the recovery of gray matter (GM) volumes after weight gain and the relation to hormonal normalization in adolescent patients with AN. As a result, a study published online in Psychosomatic Medicine (17 April 2012), assessed magnetic resonance imaging at the time of admission to the hospital (T1) and after weight recovery (T2) in 19 female patients aged 12 to 17 years. Patients were compared with typically developing girls matched for age and intelligence quotient. Structural brain images were analyzed using a voxel-based morphometric approach. Circulating levels of cortisol and gonadotropins were assessed in blood samples.


Results showed that compared with controls, patients with AN showed reduced GM in several brain regions along the cortical midline, reaching from the occipital cortex to the medial frontal areas. These GM reductions were mostly reversible at T1. Patients showed a GM increase from T1 to T2 along the cortical midline and in the occipital, temporal, parietal, and frontal lobes. GM increases at T2 correlated inversely with cortisol levels at T1 and positively with weight gain at T2. The strongest associations between regional GM increase and weight gain were found in the cerebellum. In addition, increases in GM volumes at T2 in the thalamus, hippocampus, and amygdala were associated with increases in follicle-stimulating hormone.


According to the authors, data suggest that brain alterations in adolescents with acute AN are mostly reversible at T1 and that GM recovery in specific brain regions is associated with weight and hormonal normalization.

TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area.



FDA-Led Research Team Discovers an Autoimmune Mechanism for Serious Drug-Induced Adverse Reactions



Ziagen (abacavir) is known to cause allergic reactions in certain, at-risk patients. These reactions can range from mild skin reactions to severe allergic shock and even death. Abacavir interacts with molecules in the immune system called Human Leukocyte Antigens (HLAs), specifically HLA-B*5701, which help the body to distinguish “self” versus “foreign” proteins. The drug can cause HLA-B*5701 to present for the first time certain “self” proteins that the body has not seen before. Because the body has not previously recognized these “self” proteins, it mistakenly treats them as foreign, resulting in the body trying to destroy its own tissues. HLA-B*5701 is known to be a risk factor for serious reactions to abacavir.


A team of researchers led by the U.S. FDA has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions. In an article, published ahead of print in the journal AIDS (19 May 2012), the team found that in certain at-risk patients, the anti-HIV drug abacavir causes the immune system to “see” a patient’s own healthy tissues and proteins as a foreign invader. The effect is similar to what happens when the immune system recognizes a viral or bacterial protein during an infection.


The research team’s work will provide the FDA with new tools to analyze the safety of drugs that have the potential to cause severe allergic reactions. This latest discovery will advance the FDA’s ability to approve therapies that are personalized for safety. The results also may give biopharmaceutical companies and other research organizations new methods to identify early in the development process drugs with the potential to cause severe adverse drug reactions. This may also serve as a model for future research to predict drug reactions in different populations of at-risk patients.


The research team was led by Michael Norcross, M.D., of the Office of Pharmaceutical Sciences in CDER.