SCRS Welcomes Target Health Inc. as a Site Development Partner

 

Ellicott City, MD – June 27, 2014: The Society for Clinical Research Sites (SCRS) is pleased to recognize and welcome Target Health Inc., an industry-leading full service eCRO, as a new Site Development Partner.

 

SCRS is proud to partner with Target Health,“ said SCRS President, Christine Pierre. “Collaboration with leading organizations across the clinical research landscape is a pivotal strategic platform for SCRS in support of the sites. This commitment by Target Health speaks to their strong desire to better understand the sites’ perspective, hear their voice and grow closer to the core of the research process. We applaud Target Health and thank them for their industry leadership.“ As a Site Development Partner, Target Health will work closely with key SCRS stakeholders, including its Global Impact Partners and members of the Society’s Leadership Council, to set key initiatives that will elevate site performance and enhance site sustainability.

 

SCRS is a global trade organization founded in 2012 and represents over 1,400 research sites, including 13,000 Investigators and 12,000 research staff, in 37 countries. SCRS’ mission is to unify and amplify the voice of the global clinical research site community for site sustainability. SCRS has become an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Sites, as well as companies that sponsor or support the work conducted at the clinical research sites, will benefit from membership and partnership.

 

 

Nature Hits New York City

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View from Target Health Inc.  —  Red Sky in Morning (7 am), Sailor’s Take Warning

Right before a Big Storm ©Target Health Inc.

 

ON TARGET is the newsletter of Target Health Inc., a NYC-based, full-service, contract research organization (eCRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services, including the paperless clinical trial, to the pharmaceutical and device industries.

 

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, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

Looking For Experienced Professional to Run Clinical Operation

 

To our friends and colleagues: We are looking for an experienced professional to run our clinical trials operation. Ideally, 10 years’ experience in CRO/pharma operations, minimum of Master’s degree or equivalent, very strong communication and people skills, passion to get products to the market and looks forward to working in NYC.

 

Eleanor Roosevelt, Before Palliative Care Was Part of Patient Care

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Eleanor Roosevelt with FDR’s Scotty, Fala

 

Days in the life of Eleanor Roosevelt

 

Another medical mystery was solved at the 2014 annual medical conference dedicated to notorious case histories of the past. Each year since 1995, the University of Maryland School of Medicine and the Veterans Affairs Maryland Health Care System have held a special historical “clinicopathologic conference,“ an exercise in which the history of an unnamed patient’s illness is presented to an experienced clinician for discussion in an academic setting. This method teaches medical students and residents how experienced clinicians would approach a difficult or challenging case. “We present an unusual modern case on a weekly basis, but once a year we stray from our modern lives and discuss a historical figure.“

 

The Story:

 

Prior to her terminal illness, this patient’s health had been consistently excellent. She rarely even contracted a cold, and once boasted she had never had a headache; and so she was totally unprepared for the pernicious disorder that crept into her life in early 1960. She was 75 years old and campaigning for John F. Kennedy with stump speeches in a half-dozen states from California to New York to West Virginia. Reluctantly, she consulted her personal physician, Dr. A. David Gurewitsch. A series of blood tests in April 1960 revealed mild anemia, with a hemoglobin level of 10.3 gm% and a slightly low white blood cell count of 4,450/mm3. A bone marrow aspiration revealed hypercellularity with 18% myeloblasts. Although the marrow looked suspicious for an early stage of leukemia, her doctors diagnosed aplastic anemia and explained that transfusions could bring temporary relief, but sooner or later, her marrow would break down completely and internal hemorrhaging would result. The patient’s reaction was she was “too busy to be sick.“

 

In March 1961, the patient developed soreness and swelling of her legs, which she attributed to a bout of influenza. Her son later claimed that the cause was phlebitis, and that “the experience drove her to have a new will drawn.“ The in September 1961, she was admitted to Columbia-Presbyterian Hospital after two days of vaginal bleeding for the first time since her menopause at age 50. She had been receiving irregular treatment for the previous several months with premarin to see if it would have a beneficial effect on her poorly functioning bone marrow. Following curettage, she left the hospital. When admitted, her hemoglobin had dropped two points to 8.2 gm%. More ominous were her low white blood cell count of 1,500/mm3 (with 79% lymphocytes), her platelet count of 79,000/mm3, and her elevated erythrocyte sedimentation rate (ESR) of 50 mm/hr. (normal < 20 mm/hr.). A repeat bone marrow aspiration revealed hypocellularity with only 5% myeloblasts. When transfused with two units of blood, she developed high fever and chills – her first of many transfusion reactions. A chest x-ray performed on September 5 revealed large calcified nodes in both hilar areas. The fever abated quickly, and after three days in the hospital, the patient was sent home.

 

In February 1962, she traveled abroad for the last time, visiting Israel and Switzerland. In April, because of a hemoglobin level that had fallen to 7.9 mg%, a white blood count of only 1,800/mm3, a platelet count of 87,000/mm3 and frequent bruising, her physicians decided to begin treatment with prednisone, 5 mg, hoping the drug would stimulate production of her red blood cells and platelets. Despite the prednisone, the patient continued to require periodic transfusions.

 

In July, her illness entered a new phase with the onset of low grade fever with frequent night sweats and a mild cough. In early August, she developed four days of fever to 40.5?0C following a transfusion. The fever abated but only temporarily. She could no longer count on a day when chills or fever would not force her to rest. She was admitted again to Columbia-Presbyterian Medical Center in an effort to determine the cause of her fever. An admission note dated August 4, 1962, described several days of fever, chills and night sweats, along with several weeks of a dry cough. The patient’s hemoglobin level was now 7.5 mg%, her white blood count a mere 200/mm3 (with 69% polymorphonucelar leukocytes and 31% lymphocytes) and her platelet count 83,000/mm3. Her ESR had risen sharply to 128 mm per hr. Her chest x-ray revealed questionable widening of the superior mediastinum and the bilateral hilar adenopathy, thought to be due to contact with tuberculosis in 1919 when she had been told that she had had a touch of pleurisy. The prednisone which had been decreased by the patient in late July to 2.5 mg daily, was increased to 30 mg daily in view of the fever. Because of bright red rectal bleeding, a dilatation of the anal sphincter was performed and an excision of hypertrophied anal papillae with cauterization of petechial areas of bleeding was performed. During the patient’s hospitalization in August 1962, she was treated for four days with penicillin and streptomycin for a possible pyogenic bacterial infection, while her doctors awaited the results of blood cultures, all of which were negative. Her bone marrow was unchanged.

 

She was intermittently confused and angry over her inability to force herself back to health, and then because she was not allowed to die. The endless fussing over blood tests and temperature, not to mention her bone marrow, all seemed so senseless. No sooner was she able to leave her bed than she demanded to be taken home. On August 10 she was discharged from the hospital without an explanation for her fever. Her physicians had been tapering her prednisone, but then suspecting that the aplastic anemia itself was responsible for the fever, they increased the dose to 25 mg daily. By then, the patient was only dimly aware of her surroundings. She begged Dr. Gurewitsch, not for the first time, to hasten her death. Instead, he readmitted her to the hospital on September 26 for additional tests. During this admission she had persistent fever with an odd pattern of temperature peaks occurring in the morning. She was deathly pale, covered with bruises, and passing black tarry stools. She had a Cushingoid facies and oral thrush. Her hemoglobin level was 6.2 mg%, her white blood cell count 900/mm3 (with 17% myeloblasts and one nucleated red blood cell) She needed oxygen to relieve her shortness of breath, and had had so many past injections and blood samples taken, the nurses had difficulty finding a vein in which to administer intravenous fluids. Her chest x-ray had changed. It now presented a generalized ill-defined nodularity which had not been present seven days previously on an outside study. Given the patient’s persistent fever and chills along with the nodular pulmonary infiltrate, a group consultation held on September 27 finally decided that miliary tuberculosis needed to be ruled out. Microscopic examination of a bone marrow biopsy specimen revealed normal cellularity but again failed to show any definite evidence of leukemia or tuberculous granulomata. She was treated empirically with streptomycin and INH pending the results of the bone marrow culture. In view of her intestinal bleeding and an extremely low platelet count, alternate day injections of testosterone were added to her daily prednisone.

 

The patient’s fever resolved several days after initiation of the two anti-tuberculosis drugs. However, within another few days it returned, reaching 40.5?0 on October 12. She continued to bleed per rectum and to suffer an allergic reaction each time she received a blood transfusion. Two barium enemas in search of a cause for her intestinal bleeding revealed nothing of importance.

 

Determined to die, with or without the help of her physicians, the patient began spitting out pills or hiding them under her tongue. She refused further testing and demanded to go home. Finally, having performed all of the diagnostic measures that could be done, her attending physicians felt that they could accede to her request to return to her home. On October 18, 1962, four days after U-2 reconnaissance revealed Soviet missiles being installed in Cuba, and seven days after her 78th birthday, she was carried out of the hospital on a stretcher. Her discharge medications included: digitoxin and mercuhydrin (for trace ankle edema), prednisone (15 mg every 6 hours), gelusil, isoniazid, and intramuscular colimycin, streptomycin and penicillin. Eight days later, the results of the bone marrow culture arrived. M. tuberculosis was growing in the culture tubes that had been inoculated with the patient’s marrow. Dr. Gurewitsch was ecstatic. Not only had his suspicion been confirmed, but he now had a curable disease to treat. Though his patient’s hemoglobin had dropped to 3.6 mg% and her platelets to only 30,000/mm3, he assured her that her chances for survival “had gone up by 5000%.“

 

The patient’s family was not impressed. Their mother’s suffering, they argued, had gone on long enough. Undeterred, Dr. Gurewitsch doubled the dose of INH and continued transfusing his patient at her home with blood that had been vigorously washed to prevent further allergic reactions. He also had her trachea suctioned repeatedly to clear it of secretions, and a catheter placed into her bladder to monitor her urinary output while hoping for a miracle that was not to be.

 

Years later Gurewitsch reflected upon the suffering he and his colleagues had inflicted upon their helpless patient with their endless tests and ineffectual treatments. “He had not done well by Mrs. R. toward the end,“ he said. “She had told him that if her illness flared up again and fatally that she did not want to linger on and expected him to save her from the protracted, helpless, dragging out of suffering. But he could not do it,“ he said. “When the time came, his duty as a doctor prevented him.“

 

In spite of these measure, the patient became increasingly somnolent and had increasing difficulty with oral secretions and coughing spells. Her blood pressure fell, and her pulse became thready and weak. She rallied slightly but was essentially comatose from November 5 until the late afternoon of November 7, when she had marked difficulty with oral secretions, relieved by oral and nasal suction and then by tracheal suction by Dr. Leonard Brand of the anesthesia department. Approximately 10 minutes after relief of this last episode, she became cyanotic, her heart failed, and shortly thereafter respiration ceased. Attempts at closed chest resuscitation with mouth-to-mouth breathing, and the use of intracardiac adrenalin were unsuccessful.

 

At 6:15 p.m., on November 7, 1962, Dr. Gurewitsch’s patient’s suffering ended.

_______________________________________________________________________

 

THI Editor’s Note: After reading about the terrible suffering endured by Eleanor Roosevelt, at the end of her life, we decided to devote this week’s ON TARGET Newsletter to Palliative and Hospice Care.

 

 

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Statue of Eleanor Roosevelt in Riverside Park, near Columbia University, New York City (Manhattan)

Palliative or Hospice Care During and End of Life

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A woman being treated with docetaxel chemotherapy for breast cancer.  Cold mittens and wine coolers are placed on her hands and feet to prevent deleterious effects on the nails.

 

Palliative care (also called palliative medicine and comfort care) is an area of healthcare that focuses on relieving and preventing the 1) ___ of patients. Unlike hospice care, palliative care is appropriate for patients in all disease stages, including those undergoing treatment for curable illnesses and those living with chronic diseases, as well as patients who are nearing the end of life. While palliative care may seem to offer a broad range of services, the goals of palliative treatment are concrete: relief from suffering, treatment of pain and other distressing symptoms, psychological and spiritual care, a support system to help the individual live as actively as possible and a support system to sustain and rehabilitate the individual’s family.

 

Palliative medicine utilizes a multidisciplinary approach to patient care, relying on input from physicians, pharmacists, nurses, chaplains, social workers, psychologists and other allied health professionals in formulating a plan of care to relieve suffering in all areas of a patient’s 2) ___. This multidisciplinary approach allows the palliative care team to address physical, emotional, spiritual and social concerns that arise with advanced illness.

 

Medications and treatments are said to have a palliative effect if they relieve 3) ___ without having a curative effect on the underlying disease or cause. This can include treating nausea related to chemotherapy or something as simple as morphine to treat the pain of broken leg or ibuprofen to treat aching related to an influenza (flu) infection. Although the concept of palliative care is not new, most physicians have traditionally concentrated on trying to 4) ___ patients. Treatments for the alleviation of symptoms were viewed as hazardous and seen as inviting addiction and other unwanted side effects. The focus on a person’s quality of life has increased greatly since the 1990s. In the United States today, 55% of hospitals with more than 100 beds offer a 5) ___-care program, and nearly one-fifth of community hospitals have palliative-care programs.A relatively recent development is the palliative-care team, a dedicated health care team that is entirely geared toward palliative treatment. Immediate palliative care is indicated for patients with any serious illness and who have physical, psychological, social, or spiritual distress as a result of the treatment they are seeking or receiving.

 

Palliative care increases comfort by lessening 6) ___, controlling symptoms, and lessening stress for the patient and family, and should not be delayed when it is indicated. Palliative care is not reserved for patients in end-of-life care and can increase quality of life and lengthen the patient’s life. If palliative care is indicated for a person in an emergency department, then that care should begin in the emergency department immediately and with referral to additional palliative care services. 7) ___ care physicians have a unique and critical position to begin discussions with patients and caregivers about palliative care and hospice services as they see persons in difficult times of life.

 

Palliative care is a term derived from Latin palliare, “to cloak”. It refers to specialized medical care for people with serious illnesses. It is focused on providing patients with relief from the symptoms, pain and stress of a serious illness – whatever the prognosis. The goal is to improve quality of life for both the patient and the family as they are the central system for care. Palliative care is provided by a team of doctors, nurses and other specialists who work together with a patient’s other doctors to provide an extra layer of support. It is appropriate at any age and at any stage in a serious illness and can be provided along with curative treatment.

 

A World Health Organization statement describes palliative care as “an approach that improves the quality of life of patients and their 8) ___ facing the problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual.” More generally, however, the term “palliative care” may refer to any care that alleviates symptoms, whether or not there is hope of a cure by other means; thus, palliative treatments may be used to alleviate the side effects of curative treatments, such as relieving the nausea associated with chemotherapy.

 

The term “palliative care” is increasingly used with regard to diseases other than cancer such as chronic, progressive pulmonary disorders, renal disease, chronic heart failure, HIV/AIDS and progressive neurological conditions. In addition, the rapidly growing field of pediatric palliative care has clearly shown the need for services geared specifically for children with serious illness.

 

Palliative care:

1. provides relief from pain, shortness of breath, nausea and other distressing symptoms;

2. affirms life and regards dying as a normal process;

3. intends neither to hasten nor to postpone 9) ___;

4. integrates the psychological and spiritual aspects of patient care;

5. offers a support system to help patients live as actively as possible;

6. offers a support system to help the family cope;

7. uses a team approach to address the needs of patients and their families;

8. will enhance quality of life;

9. is applicable early in the course of illness, in conjunction with other therapies that are intended to prolong life, such as chemotherapy or radiation therapy.

 

 

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Florence Sophie Schorske (1917-2008), Dean of the Yale School of Nursing and Pioneered the American Hospice movement

 

In the United States, a distinction may be made between palliative care and hospice care. Hospice services and palliative care programs share similar goals of providing symptom relief and pain management.Palliative care services can be offered to any patient without restriction to disease or prognosis, and can be appropriate for anyone with a serious, complex illness, whether they are expected to recover fully, to live with chronic illness for an extended time, or to experience disease progression. 10) ___ care under the Medicare Hospice Benefit, however, requires that two physicians certify that a patient has less than six months to live if the disease follows its usual course. This does not mean, though, that if a patient is still living after six months in hospice he or she will be discharged from the service. The philosophy and multi-disciplinary team approach are similar with hospice and palliative care, and indeed the training programs and many organizations provide both. The biggest difference between hospice and palliative care is the patient: where they are in their illness especially related to prognosis and their goals/wishes regarding curative treatment.

 

Outside the United States there is generally no such division of terminology or funding, and all such care with a primarily palliative focus, whether or not for patients with terminal illness, is usually referred to as palliative care, without restriction. Outside the United States the term hospice usually refers to a building or institution which specializes in palliative care, rather than to a particular stage of care progression. Such institutions may predominantly specialize in providing care in an end-of-life setting; but they may also be available for patients with other specific palliative care needs.

 

 

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Hospice Saint Vincent de Paul, Jerusalem

 

ANSWERS: 1) suffering; 2) life; 3) symptoms; 4) cure; 5) palliative; 6) pain; 7) Emergency; 8) families; 9) death; 10) Hospice

A Short History of Palliative Care

 

Palliative care began in the hospice movement and is now widely used outside of traditional hospice care. Hospices were originally places of rest for travelers in the 4th century. In the 19th century a religious order established hospices for the dying in Ireland and London. The modern hospice is a relatively recent concept that originated and gained momentum in the United Kingdom after the founding of St. Christopher’s Hospice in 1967. It was founded by Dame Cicely Saunders, widely regarded as the founder of the modern hospice movement.

 

The hospice movement has grown dramatically in recent years. In the UK in 2005 there were just under 1,700 hospice services consisting of 220 inpatient units for adults with 3,156 beds, 33 inpatient units for children with 255 beds, 358 home care services, 104 hospice at home services, 263 day care services and 293 hospital teams. These services together helped over 250,000 patients in 2003 & 2004. Funding varies from 100% funding by the National Health Service to almost 100% funding by charities, but the service is always free to patients.

 

Hospice in the United States has grown from a volunteer-led movement to a significant part of the health care system. In 2005 more than 1.2 million persons and their families received hospice care. Hospice is the only Medicare benefit that includes pharmaceuticals, medical equipment, twenty-four hour/seven day a week access to care and support for loved ones following a death. Most hospice care is delivered at home. Hospice care is also available to people in home-like hospice residences, nursing homes, assisted living facilities, veterans’ facilities, hospitals and prisons.

 

The first United States hospital-based palliative care programs began in the late 1980s at a handful of institutions such as the Cleveland Clinic and Medical College of Wisconsin. Since then there has been a dramatic increase in hospital-based palliative care programs, now numbering more than 1,400. 80% of US hospitals with more than 300 beds have a program. A 2009 study regarding the availability of palliative care in 120 US cancer center hospitals reported the following: Only 23% of the centers have beds that are dedicated to palliative care; 37% offer inpatient hospice; 75% have a median time of referral to palliative care to the time of death of 30 to 120 days; research programs, palliative care fellowships, and mandatory rotations for oncology fellows were uncommon. The results of a 2010 study in The New England Journal of Medicine (2010;363:733-742) showed that lung cancer patients receiving early palliative care experienced less depression, increased quality of life and survived 2.7 months longer than those receiving standard oncologic care.

 

Hospital palliative care programs today care for non-terminal patients as well as hospice patients. The Patient Protection and Affordable Care Act currently being debated by house and senate would seek to expand palliative care in the U.S. Launched in 2011, The Joint Commission’s Advanced Certification Program for Palliative Care recognizes hospital inpatient programs that demonstrate exceptional patient and family-centered care and optimize the quality of life for patients (both adult and pediatric) with serious illness. The first Pan-European Center devoted to improving patient palliative care and end-of-life care was established in Trondheim, Norway in 2009. The center is based at NTNU’s Faculty of Medicine and at St. Olav’s Hospital/Trondheim University Hospital and coordinates efforts between groups and individual researchers across Europe, specifically Scotland, England, Italy, Denmark, Germany and Switzerland, along with the USA, Canada and Australia.

ONCOLOGY

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Associations Between Palliative Chemotherapy and Adult Cancer Patients’ End of Life Care and Place of Death: Prospective Cohort Study

 

The objectives of a study published in the British Medical Journal (4 March 2014) was to determine whether the receipt of chemotherapy among terminally ill cancer patients months before death was associated with patients’ subsequent intensive medical care and place of death. The study included a secondary analysis of a prospective, multi-institution, longitudinal study of patients with advanced cancer.

 

Eight outpatient oncology clinics in the United States enrolled 386 adult patients with metastatic cancers refractory to at least one chemotherapy regimen, whom physicians identified as terminally ill at study enrollment and who subsequently died. The primary outcomes included intensive medical care (cardiopulmonary resuscitation, mechanical ventilation, or both) in the last week of life and patients’ place of death (for example, intensive care unit). Secondary outcomes included survival, late hospice referrals (<1 week before death), and dying in preferred place of death.

 

Results showed that 216 (56%) of 386 terminally ill cancer patients were receiving palliative chemotherapy at study enrollment, with a median of 4.0 months before death. After propensity score weighted adjustment, use of chemotherapy at enrollment was associated with higher rates of cardiopulmonary resuscitation, mechanical ventilation, or both in the last week of life (14% vs 2%); and late hospice referrals (54% v 37%), but no difference in survival (hazard ratio 1.11). Patients receiving palliative chemotherapy were more likely to die in an intensive care unit (11% v 2%) and less likely to die at home (47% v 66%;), compared with those who were not. Patients receiving palliative chemotherapy were also less likely to die in their preferred place, compared with those who were not (65% v 80%).

 

According to the authors, the use of chemotherapy in terminally ill cancer patients in the last months of life was associated with an increased risk of undergoing cardiopulmonary resuscitation, mechanical ventilation or both and of dying in an intensive care unit, and that future research should determine the mechanisms by which palliative chemotherapy affects end of life outcomes and patients’ attainment of their goals.

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

 

FDA Approves Afrezza to Treat Diabetes

 

An estimated 25.8 million (18.8 million diagnosed and 7.0 million undiagnosed) people in the United States or approximately 8.3% of the population have diabetes. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness and nerve and kidney damage.

 

The FDA approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal.

 

The drug’s safety and effectiveness were evaluated in a total of 3,017 participants – 1,026 participants with type 1 diabetes and 1,991 patients with type 2 diabetes. The efficacy of mealtime Afrezza in adult patients with type 1 diabetes patients was compared to mealtime insulin aspart (fast-acting insulin), both in combination with basal insulin (long-acting insulin) in a 24 week study. At week 24, treatment with basal insulin and mealtime Afrezza provided a mean reduction in HbA1c (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control) that met the pre-specified non-inferiority margin of 0.4%. Afrezza provided less HbA1c reduction than insulin aspart, and the difference was statistically significant.

 

Afrezza was studied in adults with type 2 diabetes in combination with oral antidiabetic drugs; the efficacy of mealtime Afrezza in type 2 diabetes patients was compared to placebo inhalation in a 24 week study. At week 24, treatment with Afrezza plus oral antidiabetic drugs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group.

 

Afrezza is not a substitute for long-acting insulin. Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes, and it is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke.

 

Afrezza has a Boxed Warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). Afrezza should not be used in patients with chronic lung disease, such as asthma or COPD because of this risk. The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation.

 

The FDA approved Afrezza with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care professionals about the serious risk of acute bronchospasm associated with Afrezza. The FDA is requiring the following post-marketing studies for Afrezza:

  • a clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients;
  • a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza (this trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function);
  • two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response and one to characterize within-subject variability.

 

Afrezza is manufactured by MannKind Corporation, Danbury, Connecticut.

Sweet Apricot Shrimp with Fennel and Chopped Walnuts

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Sweet Apricot Shrimp with Fennel and Chopped Walnuts ©Joyce Hays, Target Health Inc.

 

Ingredients

1/3 cup extra virgin olive oil, or more as needed

6 to 8 big cloves garlic, cut into slivers

to 1 1/2 pounds large or jumbo shrimp, peeled, rinsed, and dried. (ask that they be cleaned and de-veined by your fish market) I got mine from FreshDirect already cooked.

Salt and freshly ground black pepper (to your taste)

1 teaspoon ground cumin

1 teaspoon turmeric

1 teaspoon coriander

1 teaspoon chopped fresh ginger

Pinch of either cayenne or red chili flakes (don’t breath in the chili flakes, when cooking)

1/2 teaspoon black mustard seed (optional)

1 Tablespoon fresh parsley, chopped (same some for garnish) 1Tablespoon fresh cilantro, chopped (save some for garnish)

5-6 Mini-apricots, leave skins on

1 cup toasted walnuts, chopped after toasting

Pinch Salt and pepper (optional)

1 small fennel bulb, trimmed and thinly sliced with mandolin

3 Tablespoons Canola oil

2 or 3 Tablespoons champagne vinegar

 

Directions

Prepare the Walnuts

Toast the walnuts in a hot pan with 1 teaspoon olive oil and a tiny bit of chicken stock. Stir the nuts constantly so they don’t burn. When they turn a golden brown, remove from pan onto some paper towel and set aside. When nuts are cool, chop them into coarse pieces (not too big or too small)

 

Prepare the Mini-apricots

Wash, dry on paper towel and cut in half. Transfer to a large bowl and set aside.

Cook the herbs and spices

Warm the olive oil in a large, broad ovenproof skillet or heatproof baking pan over low heat. There should be enough olive oil to cover the bottom of the pan; don’t skimp. Add the garlic slivers and cook until garlic turns golden, a few minutes.

 

Raise the heat to medium-high and add pinch salt and pepper, the cumin and turmeric and all of the spices and herbs. Stir to blend and add the walnuts, fennel, olive oil, champagne vinegar, pinch kosher salt, pinch black pepper. Gently stir to combine. Cook for about 3 to 5 minutes. Cover until you’re ready to add the shrimp.

 

Add Shrimp

If you didn’t or couldn’t buy already cooked shrimp, add your uncooked (trimmed and deveined) shrimp to the pan and continue to cook, shaking the pan once or twice and turning the shrimp once or twice, until they are golden brown all over and the mixture is bubbly, 3 to 6 minutes. Do not overcook or the seafood will be rubbery.

 

Just before serving, add the fresh mini-apricots to the hot seafood and stir into all the spices, herbs, nuts and shrimp, just to warm it up.

 

Garnish with herbs and serve immediately with jasmine or basmati saffron rice.

 

 

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Make some fresh asparagus to go with the shrimp and rice.   ©Joyce Hays, Target Health Inc

 

Cook the asparagus in the same pan used for the shrimp dish. Cook in olive oil and lemon. Just cook for about 3 to 4 minutes, stirring.

 

My plan for this summer is to create and adapt lots of shrimp recipes, because shrimp is easy to cook, delicious, excellent source of protein and low in calories. This recipe is one that I experimented with. I found that using champagne vinegar instead of red wine vinegar was better. Also, peaches are not at their peak yet, but sweet mini-apricots are. I tried this dish with peaches and didn’t like it as well as with the mini-apricots, which are delicious now and available at FreshDirect.

 

Everything on this page is quick and easy to cook. It’s your decision whether or not to buy your shrimp already cooked. I have shopped around and find that Food Emporium and Dean and DeLuca cooked shrimp are not that good (all are over cooked) but each time I buy cooked shrimp from FreshDirect, they are perfect, so why do extra cooking in the summer?

 

My husband and I loved this whole meal of the Apricot Shrimp served with jasmine saffron rice and barely cooked local fresh asparagus. We also discovered a new low-priced New Zealand Sauvignon Blanc (2011),Cloudy Bay, which we recommend highly. We buy most of our wine from Sherry-Lehmann in Manhattan. Each month they recommend excellent new wines that don’t break the bank. This is one of them, that we tried and will now be sure to have more on hand. It awakens your taste buds with smooth silky smokey rivulets of fantastic flavor.

 

For those who like to know what’s going on in the Big Apple , we saw some extraordinary acting and singingon Saturday at The Circle in the Square, “Lady Day at Emerson’s Lounge“ starring the incredibly talented Audra McDonald, playing the role of her life, as Billy Holiday. McDonald won a 2014 Tony Award for this role, which is her 6th or 7th Tony Award, with good reason. Audra McDonald with her amazingly flexible, gorgeous and flawless voice, was able to reproduce the velvet soulful sounds of Billy Holiday. McDonald has a rare acting talent, so artful and passionate, you suspend your disbelief and for a while, are in the company of that other genius, Billy Holiday. We recommend this show highly. For us, it was a remarkable experience.

 

 

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From our table to yours

 

Bon Appetit !

eSource Publication in Applied Clinical Trials

 

Applied Clinical Trials has published our article in the June/July print edition as part of 4 articles on Clinical Trial Optimization. The article, entitled “Three-Pronged Approach to Optimizing Trial Monitoring Study – Results Using a Quality-by-Design [QbD] Method, Risk-Based Monitoring [RBM], and Real-Time Direct Data Entry [DDE],“  reports the results of the clinical trial initiated in the U.S. and Canada, which included 18 sites and 180 treated subjects where all the sites performed DDE and all the clinical research associates (CRAs) performed RBM, with the bulk of monitoring activities occurring centrally from the home office (central monitoring). For this publication, Target e*CRF® was used for EDC, Target e*CTR® Viewer was used to access the eSource records, and Target Document was used as the eTMF.

 

We are currently planning a PMA submission this year and an NDA next year, where the sites will have performed DDE at the time of the office visit and the CRAs, as part of the QbD methodology, will have performed RBM and central monitoring. We are also starting our 17th and 18th studies using DDE. There are 10 IND and 1 IDE programs, with the largest study being up to 45 centers and up to 400 subjects.

 

We are fully web-based so our system can be run using any Internet browser and at any time. We also create a certified Independent contemporaneous copy (CICC) of the eSource record before the data hit our EDC database, which is consistent with both the FDA Guidance and EMA Reflection Paper on eSource Records. We are also planning full integration with the electronic medical record (EMR) within the year with a clinical trial planned for Q3 2014. This program is being funded by the Bird Foundation.

 

We welcome collaboration with other EDC systems as we believe our solutions to DDE and EMR integration will be the industry standard.

 

Nature in New York City

 

20140623-11

Canadian Geese in Central Park ©Target Health Inc.

 

ON TARGET is the newsletter of Target Health Inc., a NYC-based, full-service, contract research organization (eCRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services, including the paperless clinical trial, to the pharmaceutical and device industries.

 

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, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

 

Keeping Clean

20140623-10

An English early 20th Century bathroom

 

Dirty water has killed more humans than all the wars of history combined, but in the last 150 years a series of new ideas and innovations have changed our world and the way we live; including John Leal MD, who added chlorine to the 1) ___ water supply of 200,000 people but transformed the way we live. In 1908 the consensus was that chlorine was lethal but he believed differently. Without authorization Leal added it to the water supply and made it safe to drink.

 

The germ theory of disease states that some diseases are caused by microorganisms. These small organisms, too small to see without magnification, invade humans, animals, and other living hosts. Their growth and reproduction within their hosts can cause a disease. “Germ“ may refer to a virus, bacterium, protist, fungus, or prion. Microorganisms that cause disease are called pathogens, and the diseases they cause are called infectious diseases. Even when a pathogen is the principal cause of a disease, environmental and hereditary factors often influence the severity of the disease, and whether a particular host individual becomes infected when exposed to the 2) ___.

 

The germ theory was proposed in the mid-16th century and gained widespread credence when substantiated by scientific discoveries of the 17th through the late 19th century. It supplanted earlier explanations for disease, such as Galen’s miasma theory. Since the germ theory of disease, cleanliness has come to mean an effort to remove germs and other hazardous materials. A reaction to an excessive desire for a germ-free environment began to occur around 1989, when David Strachan put forth the “hygiene hypothesis“ in the British Medical Journal. In essence, this hypothesis holds that dirt plays a useful role in developing the 3) ___ system; the fewer germs people are exposed to in childhood, the more likely they are to get sick as adults. The valuation of cleanliness, therefore, has a social and cultural dimension beyond the requirements of hygiene for practical purposes.

 

Cleanliness customs swing back and forth like a pendulum over the ages, from society to society and century to century. The thought of a daily shower would have filled the 17th century Frenchman with fear. To open your 4) ___ and leave your body vulnerable to all that disease, would be asking to get sick. Our bathing habits would have disgusted him, much like his habits disgust us: never washing his body with water or soap, for instance. Or changing his linen shirt to get clean.

 

Habits of cleanliness go from ancient Roman afternoons at the public baths to today’s obsession with hand sanitizer and teeth-whitening strips. Contemporary cleanliness has more to do with appearances than hygiene. If you were a man in ancient Rome, you would take off all your clothes, put a little oil on your body, rub it with dust and go out into the playing field to work up a sweat. Then you would get somebody to scrape off your perspiration with an instrument that looks like a little tiny rake, called a strigil. You would get into a tepid bath, then a hot bath, then into a cold bath. They never used any soap, and it was all done in public. 5) ___ was a combination of animal fat and lye. The Egyptians, (wealthy Egyptians cleaned themselves with fresh limes) went to great lengths to make a soap that was mild enough to use on bodies, but many cultures, including the Romans and Greeks, didn’t. So they scraped themselves. Basically, it was a kind of drastic exfoliation. They probably got as clean as soap makes you. Most people, except very rich people, didn’t use soap until about the second half of the 19th century; that’s like two thousand years.

 

The Romans had amazing technology. The great imperial baths were fed by the 6) ___ to enormous tanks called castella. Romans heated the bathhouse with impressive underfloor heating and heating within the walls. Public baths went out of fashion, probably because the infrastructure to run them – the mechanisms that brought them water, that heated their water, that separated out the different heats of the various pools – required an enormously sophisticated and complicated infrastructure, which the Roman Empire had. But when the empire started to fall apart, people couldn’t maintain that, and the invading barbarians disabled the aqueducts. There was never an empire large enough to support that again.

 

For more than 1,000 years, cleanliness was not a priority. Attitudes about which cleans better, cold water or hot water, haven’t changed much. People who support cold-water bathing, think it’s virile and virtuous, and think those who bathe in warm or hot water are feminine and not masculine. Europe suffered a hiatus in cleanliness for centuries. When the great plagues came with the Black 7) ___, in the 14th century, the king of France asked the medical faculty at the Sorbonne in Paris, “What is causing this hideous plague that is killing one out of every three Europeans, and what can we do to prevent it?“ The 14th century doctors said that people who were at risk for getting the plague had opened their pores in warm or hot water, in the baths, and they were much more susceptible. In France and England and most European countries, for about five centuries, people really believed that it was dangerous to get into water. This strong belief broke down in the 19th century.

 

There was nothing that corresponded to that belief, in Asia or in India, where they had an unbroken tradition of cleanliness. They also had religions, like Islam and Hinduism, that took cleanliness very seriously. And, yet, in some societies, the holier you were – and this really applied to monks and hermits and saints – the less you would wash. And the more you smelled, the closer to God people thought you were. In the U.S., this meant your clothes were dirty, and you needed to wash them. But the 17th century looked at the ring around your cuffs and collar and thought linen was like a wick that drew out the dirt. They believed, not only was it safer to change your linen shirt, but that it actually cleaned you better. They thought the flax in the linen exerted a kind of magnetic attraction to the sweat and drew it out of your body. So, at that time, changing your 8) ___ was the cleanest thing to do.

 

During the 17th century, people put on perfume so they wouldn’t smell their neighbors. Madame de Montespan, one of Louis XIV’s mistresses, wore clouds of self-defensive perfume so that she wouldn’t smell the king’s halitosis. She didn’t like the way he smelled, and he hated the way she smelled, because perfume gave him headaches. By about the 1840s in America, architects who made pattern books – books that everybody could buy and then build according to the patterns in the book – added a little room that was called a “bathing-room or bath-room“ for the first time, since the ancient Romans, which meant that, eventually, there would be fixed plumbing in that room. But for a long time, well into the 1920s in rural places, you would just move a tin tub into the kitchen on Saturday night and fill it with warm water, and then everybody in the family, one by one, would get into the same water, starting with the father, considered to be the most important, and going down to the daughter-in-law, who was the least important.

 

Very gradually. One of the things that probably enabled indoor bathing to happen was the fashion for spas in naturally occurring springs all over Europe. The Romans always situated their baths near a mineral spring if they could, because their doctors believed there were health-giving properties in them. Even when people were afraid to get into 9) ___ on a regular basis, if you were sick, if you had arthritis or were infertile or had some medical condition, under your doctor’s care you would go to some place like Baden in Switzerland or Bath in England and take the treatments, which included getting into water. Perhaps, because only wealthy people could afford to go to these spas, bathing eventually became chic. About a third of London houses had in-house plumbing by the 1830s, which was far above what the people had in Paris. The water inspector for Paris said the Parisians would never want this, and it would render their houses damp forever.

 

By the mid-18th century, doctors had a little bit more understanding of physiology, and that your pores needed to be open so that they could let out sweat and other things. They thought you let out an awful lot more through your pores than people actually did. It gradually began to be thought of as healthy to clean your pores and let yourself perspire, but it took a long time. Perhaps the American obsession with cleanliness, is a continuation of something that started with the Civil War, when the Americans had surprising success with the Sanitation Commission, which was headed by Frederick Law Olmsted, the architect of Central Park. It achieved an enormous success in limiting deaths just by washing the patients, their linen, the walls of their rooms. It drastically cut into the deaths by disease and infection. Now, we know that just washing hands often, whether in a hospital or not, kills germs that matter.

 

Before the Civil War Americans had been just as dirty as Europeans, and they came out of the war thinking cleanliness is democratic because it doesn’t cost much money. It’s progressive. It’s forward-looking. It has wonderful results. They quickly thought this is yet another way in which life in the New World is so much better than life in the Old World. The invention of modern sophisticated advertising, which began in America at the end of the 19th century, achieved an enormous success, often by advertising things like toilet soap and deodorant.

 

And yet, Charles P. Gerba MD (Univ Arizona), sent his researchers into public washrooms and found that only about 15% of people there actually wash long enough and with soap, demonstrating that our current interest in cleanliness is really about appearance and not ever smelling like a human being. If we smell like mangoes or vanilla and our face looks clean and our teeth are paper white, that’s good enough. But really the one seriously disease-preventing practice of hand washing is not done enough. On the other hand, it’s increasingly believed by a large number of doctors and scientists, that we’re not giving part of our immune system enough of a challenge, with dirt and germs to deal with, overcome and get stronger (as a result). As a result we’re enabling a part of our immune system, the one that gets allergies and asthma, to take over.

 

It’s like a see-saw: The one that really can work on dirt and bacteria has nothing to do, and so it becomes unexercised (don’t use it, you lose it), and it stays on the ground. The other part is up in the air. Scientists couldn’t understand why we had these skyrocketing rates of asthma and allergies. Now the hypothesis is that we are oversanitized to the point of making our children sick. Bathing is now thought by many doctors to be a social convention. However, doctors make it clear that it’s very important to wash 10) ___. About a quarter of U.S. houses built in 2005 had three or more bathrooms. Has this room where you bathe become a status symbol?

 

In the 19th century, Harriet Beecher Stowe, who wrote “Uncle Tom’s Cabin,“ said she dreamed of a time when there would be one bathroom in an American house for every three or four bedrooms. People at the time thought this was utopian thinking, compared to what they were used to. Now a luxury apartment in Manhattan, has more bathrooms than bedrooms. We’ve never needed to wash less in the developed Western countries, and we’ve never had more pressure to wash more. If your job is in front of your computer, and if you have a house full of labor-saving devices, you’re not scrubbing floors very often, and if you have access to a car or public transit where you live, you’re not sweating the way people did 50 years ago. However, a daily bath is the minimum. More and more people now take two showers a day. Advertising has pushed psychological hot buttons, and convinced Americans that they will be more popular and successful if they buy the myriad cleansing and beautifying products on the market. Caveat Emptor! Or, beware of what you wish for.

 

ANSWERS: 1) New Jersey; 2) pathogen; 3) immune; 4) pores; 5) Soap; 6) aqueducts; 7) Death; 8) shirt; 9) water; 10) hands

 

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