Target Health Eating and the eClinical Forum
This past week, Yong Joong Kim, Dean Gittleman and Jules Mitchel of Target Health attended the semi-annual meeting of the eClinical Forum. Topics included eSource, EHR in Clinical Research, Risk-Based Monitoring, TransCelerate, ePRO Products as Medical Devices, Investigator Portals, Working in the Cloud, etc. This is an organization with a great group of passionate and visionary people.
Because some participants either owned a farm or knew people who did, at dinner, the topic of what to do with an excess supply of kale came up. Immediately, the new feature of Target Health Eating (see below) was “thrown into the pot.” Not all readers were aware of our new feature which allows you to eat well, enjoy the experience and keep off the pounds. A long conversation ensued where all around the table committed to at least try a recipe or 2, or send at least one recipe to On Target for “public consumption.” Our editor and chief Joyce Hays appreciates the kudos for her brilliant new feature. We promise a kale recipe shortly.
The eClinical Forum was formed in 2000 by pharmaceutical industry representatives with a vision to create a non-commercial and informal environment in which to network with peers, share ideas and experiences, and to shape the future of the clinical research environment. The group today boasts an extensive membership of global companies from the biopharmaceutical and healthcare sectors and it covers research, technology and service provision.
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
Morphine Pain Killer
This is a facsimile of the Squibb produced morphine syrette used during World War II by doctors and medics. The needle attached to the syrette was used by the medic to puncture the seal. The medic would come along, break the seal and inject the wounded soldier with the morphine syrette.
The Use of Morphine as a Pain Killer During World War II
Morphine, as a pain killer, was widely used during World War II. Morphine is processed from the opium 1) ___ plant which is grown mainly in Turkey and India. As long ago as CE 100, 2) ___ was swallowed or taken with a beverage. In the 17th century, when opium smoking was introduced into 3) ___, a serious addiction problem resulted. After the invention of the hypodermic syringe during the American 4) ___ War (1861-1865), morphine injections proved indispensable for patients undergoing surgery. Injecting morphine into the 5) ___ proved more addictive than smoking or eating opium.
During World War II, Squibb, a pharmaceutical company, developed a way for medics to administer on the front lines a controlled amount of morphine to 6) ___ soldiers. What Squibb introduced was called a morphine syrette, which was like a miniature toothpaste tube that contained the morphine. Instead of unscrewing a top like you do on a toothpaste tube, it had a blind end that was sealed. A needle attached to the syrette was used by the medic to puncture the seal. The medic would come along, break the seal and inject the wounded soldier with the 7) ___ syrette.
During World War II, Medics were allowed to administer morphine to alleviate 8) ___, although the injection could also be given at the Battalion, or Collecting Stations. If the drug was applied , the syrette was pinned to the casualty’s collar to prevent overdosing of unconscious patients. Usually the 1/2 grain injection from the toothpaste tube shaped syrette, combined with physical exhaustion, was sufficient to knock the patient out, with the casualty often waking up in the 9) ___.
ANSWERS: poppy; 2) opium; 3) China; 4) Civil; 5) blood; 6) wounded; 7) morphine; 8) pain; 9) hospital
An American medic administers plasma to a wounded soldier
(National Archives, Washington D.C.
Dwight David Eisenhower (1890– 1969)
Looking back at the WW2 era: An M.D.’s Guide to Ike’s Heart and Health
If you happen to tour the Eisenhower historic site here on a Friday afternoon, chances are that your guide’s badge will read “M.D.” That is because the 85-year-old tour guide was Dwight and Mamie Eisenhower’s physician. When William North Sterrett retired as a family practice doctor in his native central Pennsylvania in 1990, he decided to volunteer his time at the Eisenhower home and farm, which he had visited so often as a physician. The staff quickly realized that it had a natural tour guide on its hands.
The Eisenhowers originally bought 189 acres adjacent to the Civil War battlefield in 1950. They rebuilt the existing house in 1955 and used the property intermittently while they lived in the White House. Gettysburg became their home when they left the White House, in 1961. In 1980, a year after Mrs. Eisenhower’s death, the National Park Service opened the historic site, which includes the couple’s modified Georgian farmhouse, a barn built in 1887 and a putting green from the 1950’s.
For Dr. Sterrett, volunteering is a way to keep alive his connection to the Eisenhowers. Born in rural Mifflintown, Pa., he graduated from the University of Pennsylvania Medical School in 1943. After a brief internship and some military training, he was assigned to the 32nd General Hospital Unit, spending the end of World War II in Osaka, Japan. It was there, in 1945, that Dr. Sterrett first met General Eisenhower, who as the commander of Allied Forces in Europe had just defeated the Nazis. The general was visiting the Pacific theater, where the war against the Japanese was still going on. After the war, Dr. Sterrett returned to Pennsylvania, setting up a medical practice in Arendtsville with his brother-in-law. At the end of 1960, Dr. Sterrett received a telephone call from Dr. Harold Johnson, a Gettysburg physician. Dr. Johnson had been asked to become the primary physician for the Eisenhowers when they moved to Gettysburg. He had agreed, but wanted help. He chose Dr. Sterrett.
The doctors knew a lot about Eisenhower’s medical history, and so did the rest of the country. In 1955, in his first term, Eisenhower had suffered a heart attack. Although his physicians originally tried to conceal what had happened, Eisenhower disagreed, instructing his press secretary, James C. Hagerty, to “tell them everything.” Eisenhower’s case, in contrast to the illnesses of Presidents Woodrow Wilson and Franklin D. Roosevelt, set a new standard for disclosure. Indeed, discussion of intimate details, like the president’s bowel movements, made some people squeamish. Eisenhower suffered two other major illnesses in his presidency. In 1956, he underwent surgery for an obstruction caused by Crohn’s disease, an inflammation of the intestines. In 1957, he had a small stroke. But his health remained reasonably good for the rest of his term. And from 1961 to 1965, Dr. Sterrett recalls, things were quiet, and he was able to address a series of chronic disorders.
For example, Eisenhower was under strict orders to eat a bland diet for his Crohn’s disease. But one morning Dr. Johnson called Dr. Sterrett to tell him that Eisenhower was experiencing great discomfort in his abdomen. The physicians immediately made a house call and found their patient in severe pain. As Dr. Sterrett recalls, they asked the former president what he had eaten for dinner the previous night. “Pig knuckles and sauerkraut,” Eisenhower quickly replied, knowing full well that he had violated the rules. When Dr. Johnson asked him why he had done it, Eisenhower was equally forthright. “ ‘Cause I like it, darn it!” he declared. The problem soon went away.
Another major concern was Eisenhower’s heart. In the 1960’s, the risk factor model for preventing heart disease was first gaining popularity. Dr. Sterrett knew that he might avoid another heart attack by controlling his patient’s hypertension and getting him to stop smoking. Eisenhower did take his blood pressure pills but cigarettes were another matter. Although Dr. Sterrett pointed out the growing evidence that smoking caused heart attacks and lung cancer, Eisenhower continued his habit. At some point, Dr. Sterrett stopped pleading. When you’re talking to a five-star general, he confesses, “you don’t usually tell him what to do.”
Given his relatively good health in the early 60’s, Eisenhower remained very active, traveling around the globe, maintaining an office at nearby Gettysburg College and playing golf. But in 1965, he was admitted to Walter Reed Hospital in Bethesda, Md., for more heart problems. By this point, he was beginning to develop congestive heart failure, in which water accumulates in the body. Dr. Sterrett treated him with diuretics to remove the fluid. The doctor also recommended bed rest and a low-salt diet. As was typical, the active and opinionated Eisenhower did not follow orders.
By the last year of his life, Dwight Eisenhower was in and out of Walter Reed, where doctors tried to manage his worsening heart disorder. He died there on March 28, 1969, at the age of 78. Dr. Sterrett remained as Mamie Eisenhower’s physician for the next 10 years, and succeeded in getting her to stop smoking. Mrs. Eisenhower remained quite healthy until September 1979, when she suffered a major stroke. Dr. Sterrett found her in bed, where she customarily did her writing and directed the household. As usual, her husband’s half of the bed was full of books, which Mamie kept there to feel less lonely. Mrs. Eisenhower died at Walter Reed Hospital on Nov. 1, 1979, at 82.
Source: The New York Times, by Barron H. Lerner MD
Study Finds Leisure-Time Physical Activity Extends Life Expectancy As Much As 4.5 Years
The U.S. Department of Health and Human Services, the parent agency of NIH, recommends that adults ages 18 to 64 engage in regular aerobic physical activity for 2.5 hours at moderate intensity-or 1.25 hours at vigorous intensity-each week. Moderate activities are those during which a person could talk but not sing. Vigorous activities are those during which a person could say only a few words without stopping for breath.
According to an article published in PLoS Medicine (6 November 2012), it was shown that leisure-time physical activity is associated with longer life expectancy, even at relatively low levels of activity and regardless of body weight. In order to determine the number of years of life gained from leisure-time physical activity in adulthood, which translates directly to an increase in life expectancy, the authors examined data on more than 650,000 adults. These people, mostly age 40 and older, took part in one of six population-based studies that were designed to evaluate various aspects of cancer risk.
After accounting for other factors that could affect life expectancy, the authors found that life expectancy was 3.4 years longer for people who reported they got the recommend level of physical activity. People who reported leisure-time physical activity at twice the recommended level gained 4.2 years of life. In general, more physical activity corresponded to longer life expectancy. The authors even saw benefit at low levels of activity. For example, people who said they got half of the recommended amount of physical activity still added 1.8 years to their life.
The authors also found that the association between physical activity and life expectancy was similar between men and women, and blacks gained more years of life expectancy than whites. The relationship between life expectancy and physical activity was stronger among those with a history of cancer or heart disease than among people with no history of cancer or heart disease.
The authors also examined how life expectancy changed with the combination of both activity and obesity. Obesity was associated with a shorter life expectancy, but physical activity helped to mitigate some of the harm. People who were obese and inactive had a life expectancy that was between five to seven years shorter (depending on their level of obesity) than people who were normal weight and moderately active.
Physical activity has been shown to help maintain a healthy body weight, maintain healthy bones, muscles and joints, promote psychological well-being, and reduce the risk of certain diseases, including some cancers.
Gene Variations Linked To Lung Cancer Susceptibility in Asian Women
Lung cancer in never-smokers is the seventh leading cause of cancer deaths worldwide, and the majority of lung cancers diagnosed historically among women in Eastern Asia have been in women who never smoked. Although environmental factors, such as secondhand smoke (also known as environmental tobacco smoke) or exhaust from indoor cooking are likely account for some cases of lung cancer among Asian women who have never smoked, they explain only a small proportion of the disease. To gain a better understanding of lung cancer in Asian female never-smokers, authors from the National Cancer Institute (NCI), partnered with researchers from several other countries to create the Female Lung Cancer Consortium in Asia to conduct one of the largest genome-wide association studies (GWAS) in female never-smokers to date. GWAS compares DNA markers across the genome between people with a disease or trait to people without the disease or trait.
Results from the study showed that there were three genetic regions that predispose Asian women who have never smoked to lung cancer. The finding provides further evidence that risk of lung cancer among never-smokers, especially Asian women, may be associated with certain unique inherited genetic characteristics that distinguishes it from lung cancer in smokers. The specific genetic variations found in this study had not been associated with lung cancer risk in other populations.
The consortium, whose findings were reported online in Nature Genetics (11 November 2012), conducted a GWAS that combined data from 14 studies that included approximately 14,000 Asian women (6,600 with lung cancer and 7,500 without lung cancer). The studies included data on environmental factors, including exposure to secondhand smoke. Results showed that variations at three locations in the genome — two on chromosome 6 and one on chromosome 10 — were associated with lung cancer in Asian female never-smokers. The discovery on chromosome 10 was particularly significant because it has not been found in any other GWAS of lung cancer in white or Asian populations.
The authors did not detect an association with variations at a location on chromosome 15 that has been associated with lung cancer risk in many previous GWAS of lung cancer in smokers. The absence of this association provides further support for the suggestion that the genetic variation on chromosome 15 may be smoking-related. The authors found some evidence that Asian women with one of the newly identified genetic variants may be more susceptible to the effects of environmental tobacco smoke. However, the authors note that more research is needed to draw definitive conclusions from this observation.
MRI and EEG Could Identify Children at Risk for Epilepsy after Febrile Seizures
Seizures that occur during the course of a high fever, known as febrile seizures, affect 3-4% of all children. Most such children recover rapidly and do not suffer long-term health consequences. However, having one or more prolonged febrile seizures in childhood is known to increase the risk of subsequent epilepsy. Some experts estimate that the risk of later epilepsy is 30-40% following febrile status epilepticus (FSE), a seizure or series of seizures that can last from 30 minutes to several hours. Temporal lobe epilepsy can cause memory loss, and brain scans of adults with the disorder sometimes reveal shrinkage and cell loss within the temporal lobe and hippocampus. Many adults with the disorder also report a history of FSE.
Seizures during childhood fever are usually benign, but when prolonged, they can foreshadow an increased risk of epilepsy later in life. Now a study funded by the National Institutes of Health and published online in Neurology (25 July 2012 and 7 November 2012) suggests that brain imaging and recordings of brain activity could help identify the children at highest risk. The study reveals that within days of a prolonged fever-related seizure, some children have signs of acute brain injury, abnormal brain anatomy, altered brain activity, or a combination.
The Consequences of Prolonged Febrile Seizures in Childhood (FEBSTAT) study is focused specifically on FSE and the risk of temporal lobe epilepsy. This is one of the most common forms of epilepsy and is characterized by seizures in the temporal lobe, a brain region important for memory. Within days of FSE, the children in the study underwent magnetic resonance imaging (MRI) and electroencephalography (EEG). The latter technique uses sensors on the scalp to record brain activity, and is often used to diagnose and monitor epilepsy.
The MRI scans revealed that FSE is sometimes associated with abnormalities in the hippocampus, a peapod-shaped structure within the temporal lobe. Of 191 children with FSE, 22 (11.5%) had signs of hippocampal injury on MRI, and 20 (10.5%) had developmental abnormalities of the hippocampus. Abnormal MRI results were rare among children with simple febrile seizures, defined as lasting 10 minutes or less. Out of 96 children with such seizures, only two (2.1%) had developmental abnormalities of the hippocampus and none had signs of brain injury. Nearly half (45.2%) of the children with FSE had abnormal EEG findings. There was also a correlation between the MRI and EEG findings. Children with evidence of acute brain injury after FSE were more than twice as likely to have abnormal EEG findings.
The results suggest that for some children, prolonged febrile seizures injure the brain. For others, pre-existing abnormalities could make the brain susceptible to febrile seizures. Both of these paths could in turn lead to epilepsy, but that will take more time to confirm.
FEBSTAT began almost 10 years ago. Children with FSE were enrolled from 2003-2010 at five sites: Montefiore Medical Center and Jacobi Hospital in the New York City; Lurie Children’s Hospital in Chicago; Duke University Medical Center in Durham, N.C.; Virginia Commonwealth University Hospital in Richmond; and Eastern Virginia Medical School in Norfolk. The children underwent blood tests, a neurological exam, MRI, and EEG within 72 hours of being seen in the emergency room for FSE. The blood samples are being analyzed for viral infections linked to febrile seizures and for the presence of gene mutations that could contribute to epilepsy. The children continue to receive neurological exams, MRI and EEG at regular intervals.
TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area.
Fighting Antibiotic Resistance
We recently discovered this blog (FDA Voice) so we wanted to share the website and the following article with our readers. We just did a little editing.
By: Rachel Sherman, M.D., M.P.H., Associate Director for Medical Policy (CDER) and Edward Cox, M.D., M.P.H., Director of the Office of Antimicrobial Products (CDER)
Antibiotic resistance is one of the world’s most pressing public health threats. Antibiotics are the most important tools we have to combat life-threatening bacterial diseases, but overuse of these drugs has led to the emergence of drug-resistant bacteria, or “superbugs.”
This week is the annual Get Smart About Antibiotics Week, a national campaign sponsored by FDA, CDC and other public health organizations, to highlight how important it is to use antibiotics wisely. The thrust of the message is that the key to combating antibiotic resistance is antibiotic stewardship, making sure we use the drugs appropriately – and only when needed – to help preserve their effectiveness in fighting bacterial infections. The medical community should make sure that the antibiotic and dose they prescribe will be effective in treating the infection. And patients must be sure to take an antibiotic exactly as instructed by their prescriber and complete the entire course of treatment, even if they start feeling better.
But as we take care to use existing antibiotics wisely, we realize that we will always need new antibiotics. Bacteria will continue to evolve and develop resistance to the drugs we have now. Unfortunately, research and development for new antibiotics has been in decline in recent decades, and the number of new antibiotics has been falling steadily since the 1980s.
To address this decline, FDA recently established a new internal task force to help support the development of new antibiotics. The Antibacterial Drug Development Task Force is a multi-disciplinary group of FDA scientists and clinicians working with experts from all over the country to establish new ways of developing safe and effective new antibiotics. FDA has already held several meetings to discuss the challenges to creating new antibiotics and explore possible solutions. And although still in the early stages of meeting the challenges, as co-chairs of the task force, FDA is encouraged by the frank and open discussions we are having with experts from academia, industry, professional societies, patient advocates and our fellow government colleagues.
It will take time before new antibiotics are available to treat some currently resistant infections. But if we act now and work together, we can improve antibiotic use and preserve the effectiveness of these important medicines.
Looking Back at the WW2 Era: The Eisenhower’s Favorite Recipes
One of Ike Eisenhower’s hobbies was cooking. Below are some of the favorite recipes from the Dwight D. Eisenhower Presidential Library and Museum. These are recipes that Ike and Mamie Eisenhower gave out to friends and newspapers. The wording has not been changed in any way.
President Eisenhower’s Recipe for Vegetable Soup
Trout Pan Fried
President Ike Eisenhower’s (short) recipe tor trout
In a pan over an open fire, fry some bacon and cook the fish in a combination of the bacon drippings and butter. Before frying the fish, dredge the trout in a sack of corn meal, seasoned with salt and pepper. It takes only about five or ten minutes to cook.
Mrs. Mamie Eisenhower’s Recipe for Fluffy Turnips
- 6 medium turnips
- 2 egg yolks
- 1 teaspoon salt
- Dash of cayenne pepper
- 1/8 teaspoon basil
- 1 teaspoon grated lemon rind
- 2 egg whites
- 2 tablespoons brown sugar
Cook cubed turnips until tender, about 20 minutes. Drain and mash. Beat egg yolks and add to turnips along with salt and pepper, basil and lemon rind. Beat egg whites and fold gently into turnip mixture. Pour into casserole, sprinkle with brown sugar and bake 20 minutes