Science Weekly Extra podcast: Requiem for the space shuttle

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In an extended interview, former Nasa astronaut Jeff Hoffman reflects on 30 years of the space shuttle

Science Weekly podcast: Electric cars, the space shuttle and yeast

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Shai Agassi’s vision of a green future; former Nasa astronaut Jeff Hoffman reflects on 30 years of the shuttle; and the sex life of yeast

Target Health is Off Monday in Celebration of President’s Day

Target Health will be closed Monday in celebration of President’s Day in the US. Considering what is going on in the world today, clearly having presidents who get elected with term limits is a good idea.

As always, our key people and project managers are reachable.

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. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com

Flaxseed

A long-time client and friend of Target Health Inc., Tibor Sipos PhD, president of Digestive Care Inc., has been taking ground flax seeds for years, in large quantities. It is his feeling, that these mega doses of ground flax seeds, are what has kept him so healthy over the years. We wanted to pass this information on to our readers. We suggest that you check with your doctor before including this food supplement in your diet.

Most nutrition experts recommend ground flaxseed because your body is better able to digest it. Whole flaxseed may pass through your 1) ___ undigested, which means you won’t get all the health benefits. Flaxseed is high in fiber, omega-3 fatty acids and phytochemicals called lignans. Flaxseed is commonly used as a laxative (to improve digestive health or relieve constipation). Both flaxseed and flaxseed oil have been used to help reduce total blood 2) ___ and low-density lipoprotein (LDL, or “bad”) cholesterol levels and, as a result, may help reduce the risk of heart disease. Although flaxseed oil also contains omega-3 fatty acids, it doesn’t have the beneficial fiber that the 3) ___ have.

You can purchase raw flaxseed in bulk – whole or ground – at many grocery stores and health food stores. Whole seeds can be ground in a coffee grinder and then stored in an airtight container for several months. 4) ___ whole seeds may also extend their freshness.

Although the Institute of Medicine has not set a recommended daily intake for 5) ___-3 fatty acids, it has established adequate intake amounts of between 1.1 and 1.6 grams a day for adults. One tablespoon of ground flaxseed provides 1.6 grams of omega-3 fatty acids.

Tips for including flaxseed in your diet

  • Add a tablespoon of ground flaxseed to your hot or cold breakfast 6) ___l.
  • Add a teaspoon of 7) ___ flaxseed to mayonnaise or mustard when making a sandwich.
  • Mix a tablespoon of ground flaxseed into an 8-ounce container of yogurt.
  • Bake ground flaxseed into cookies, muffins, breads and other baked goods.

ANSWERS: 1) intestine; 2) cholesterol; 3) seeds; 4) Refrigerating; 5) omega-; 6) cereal; 7) ground

Source: Mayo Clinic

Earliest Medical Schools

Kos Asklepeion, Ancient Temple of Healing

The first known Greek medical school opened in Cnidus in 700 BCE. Alcmaeon, author of the first anatomical work, worked at this school, and it was there that the practice of observing patients was established. The most important figure in ancient Greek medicine is the physician Hippocrates (460 BCE-370 BCE), known as the “Father of Medicine.” Hippocrates, who established his own medical school at Cos, and his students documented many conditions in the Hippocratic Corpus, and developed the Hippocratic Oath for physicians, still in use today.

The Hippocratic Corpus is a collection of around seventy early medical works from ancient Greece strongly associated with Hippocrates and his students. The existence of the Hippocratic Oath implies that this “Hippocratic” medicine was practiced by a group of professional physicians bound (at least among themselves) by a strict ethical code. Aspiring students normally paid a fee for training and entered into a virtual family relationship with his teacher. This training included some oral instruction and probably hands-on experience as the teacher’s assistant, since the Oath assumes that the student would be interacting with patients. The Oath also places limits on what the physician may or may not do (“To please no one will I prescribe a deadly drug”) and intriguingly hints at the existence of another class of professional specialists, perhaps akin to surgeons (“I will leave this operation to be performed by practitioners, specialists in this art”).

Despite their known respect for Egyptian medicine, attempts to document any particular influence on Greek practice at this early time have not been successful. However, it is clear, however, that the Greeks imported Egyptian substances into their pharmacopoeia, and the influence becomes more pronounced after the establishment of a school of Greek medicine in Alexandria.

Temples dedicated to the healer-god Asclepius functioned as centers of medical advice, prognosis, and healing. At these shrines, patients would enter a dream-like state of induced sleep known as “enkoimesis” not unlike anesthesia, in which they either received guidance from the deity in a dream or were cured by surgery. Asclepeia provided carefully controlled spaces conducive to healing and fulfilled several of the requirements of institutions created for healing. In the Asclepieion of Epidaurus, three large marble boards dated to 350 BCE preserve the names, case histories, complaints, and cures of about 70 patients who came to the temple with a problem and were “cured”. Some of the surgical cures listed, such as the opening of an abdominal abscess or the removal of traumatic foreign material, are realistic enough to have taken place, but with the patient in a state of enkoimesis induced with the help of soporific substances such as opium.

Asclepius is the god of medicine and healing in ancient Greek religion. Asclepius represents the healing aspect of the medical arts; his daughters are Hygieia (“Hygiene”), Iaso (“Medicine”), Aceso (“Healing”), Aglaea/AEgle (“Healthy Glow”), and Panacea (“Universal Remedy”). The rod of Asclepius, a snake-entwined staff, remains a symbol of medicine today, although sometimes the caduceus, or staff with two snakes, is used instead. He was associated with the Roman/Etruscan god Vediovis. He was one of Apollo’s sons, sharing with Apollo the epithet Paean (“the Healer”). Some historians have proposed that there may have been a historical Asclepius during the Greek Dark Ages, who became the subject of a Hero cult and on whom the mythological character was based. Right graphic: Asclepius is seated with his daughter, Hygieia.

Protein Essential for Embryo Implantation is Identified

At the start of each menstrual cycle, levels of the hormone estrogen begin to rise. Estrogen stimulates the cells in the uterine lining to increase in number, causing the epithelium to thicken. However, as the ovary releases an egg, levels of the hormone progesterone begin to rise. The elevated progesterone levels put the brakes on the estrogen-driven growth of the uterine epithelium.

According to an article published in Science (2011;331:912-916), a study has identified a key step in the establishment of a pregnancy when a protein, called Hand2, suppresses the chemical activity that stimulates growth of the uterine epithelium. In the study, it was discovered that Hand2, previously found to increase in uterine cells as progesterone levels rise, is the switch that turns off estrogen’s stimulating effect on the epithelium. According to the authors, the finding may contribute to understanding some forms of unexplained female infertility. The finding also has implications for understanding disorders in which growth of the uterine epithelium surges out of control, such as endometrial cancer or endometriosis, a disease in which endometrial tissue appears on the ovaries, bowel, or other tissues outside the uterus.

The research was supported by the NICHD Specialized Cooperative Centers Program in Reproduction and Infertility Research, a collaborative network of basic and clinical scientists who study ways of improving reproductive health.

For the current study, the researchers developed a laboratory strain of mice in which the uterus fails to make Hand2. Results showed that exposure to progesterone halted growth of the uterine epithelium in mice with functioning genes for Hand2, but, despite exposure to progesterone, epithelial growth continued unchecked in the mice without Hand2 genes. The study also discovered that, at the time of implantation, Hand2 was expressed in uterine cells that lie beneath the surface layer of epithelial cells. Through a series of experiments, it was determined that estrogen stimulates the production of growth factors, which cause cells in the epithelial layer to multiply and grow. When progesterone is produced, it spurs the release of Hand2, which stops the production of growth factors. The uterine epithelial cells then stop multiplying, mature, and become receptive to the embryo.

Treatment Approaches to Chronic Fatigue Syndrome

Comparison of Adaptive Pacing Therapy, Cognitive Behavior Therapy, Graded Exercise Therapy, and Specialist Medical Care for Chronic Fatigue Syndrome (PACE)

Trial findings show cognitive behavior therapy (CBT) and graded exercise therapy (GET) can be effective treatments for chronic fatigue syndrome, but patients’ organizations have reported that these treatments can be harmful and favor pacing and specialist health care. As a result, a study published online in The Lancet (18 February 2011) was performed to assess effectiveness and safety of all four treatments.

For the study, patients meeting Oxford criteria for chronic fatigue syndrome were recruited from six secondary-care clinics in the UK and randomly allocated by computer-generated sequence to receive specialist medical care (SMC) alone or with adaptive pacing therapy (APT), CBT, or GET. Primary outcomes were fatigue (measured by Chalder fatigue questionnaire score) and physical function (measured by short form-36 subscale score) up to 52 weeks after randomization. Safety was assessed primarily by recording all serious adverse events, including serious adverse reactions to trial treatments. Primary outcomes were rated by participants, who were necessarily unmasked to treatment assignment; the statistician was masked to treatment assignment for the analysis of primary outcomes. Longitudinal regression models were used to compare SMC alone with other treatments, APT with CBT, and APT with GET. The final analysis included all participants for whom we had data for primary outcomes.

Compared with SMC alone, mean fatigue scores at 52 weeks were 3.4 points lower for CBT (p=0·0001) and 3.2 points lower for GET (p=0·0003), but did not differ for APT. Compared with SMC alone, mean physical function scores were 7.1 points higher for CBT (p=0.0068) and 9.4 points higher for GET (p=0·0005), but did not differ for APT. Compared with APT, CBT and GET were associated with less fatigue (CBT p=0.0027; GET p=0.0059) and better physical function (CBT p=0.0002; GET p<0.0001).

According to the authors, CBT and GET can safely be added to SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition.

AGING

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Growth Hormone Receptor Deficiency and Aging

Growth Hormone Receptor Deficiency Is Associated with a Major Reduction in Pro-Aging Signaling, Cancer, and Diabetes in Humans

Mutations in growth signaling pathways extend life span, as well as protect against age-dependent DNA damage in yeast and decrease insulin resistance and cancer in mice.

To test this effect in humans, a study published in Science Translational Medicine (2011:3:70), monitored, for 22 years, Ecuadorian individuals who carry mutations in the growth hormone receptor (GHR) gene that leads to severe GHR and IGF-1 (insulin-like growth factor–1) deficiencies. This information was combined with surveys to identify the cause and age of death for individuals in this community who died before this period.

Results showed that individuals with GHR deficiency exhibited only one nonlethal malignancy and no cases of diabetes, in contrast to a prevalence of 17% for cancer and 5% for diabetes in control subjects. A possible explanation for the very low incidence of cancer was suggested by in vitro studies: Serum from subjects with GHR deficiency reduced DNA breaks but increased apoptosis in human mammary epithelial cells treated with hydrogen peroxide. Serum from GHR-deficient subjects also caused reduced expression of RAS, PKA (protein kinase A), and TOR (target of rapamycin) and up-regulation of SOD2 (superoxide dismutase 2) in treated cells, changes that promote cellular protection and life-span extension in model organisms.

The study also observed reduced insulin concentrations (1.4 µU/ml vs. 4.4 µU/ml in unaffected relatives) and a very low HOMA-IR (homeostatic model assessment-insulin resistance) index (0.34 versus 0.96 in unaffected relatives) in individuals with GHR deficiency. This observation suggests higher insulin sensitivity, which could explain the absence of diabetes in these subjects.

According to the authors, the results provide evidence for a role of evolutionarily conserved pathways in the control of aging and disease burden in humans.

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

FDA Finalizes Regulation For Certain Software, Hardware Used With Medical Devices

The FDA has announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.

“This rule is a common-sense regulatory approach that provides clarity and predictability for manufacturers of these data systems,” said Jeffrey Shuren, M.D., director of the Center for Devices and Radiological Health. “This shows our flexibility in applying regulations for medical device data systems that are not overly burdensome for manufacturers but continue to assure that data stored, transferred or displayed on these systems remain reliable.”

Medical Device Data Systems are off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification. Examples of MDDS products include: devices that collect and store data from a blood pressure cuff for future use or that transfer thermometer readings to be displayed at a nursing station for future use.

Prior to this rule, first proposed in 2008, FDA considered these devices to be either Class III (or high-risk) devices requiring premarket approval or accessories to an existing medical device. By down-classifying these devices into Class I, the FDA is exempting all manufacturers of MDDS from premarket notification and applying the level of regulation reserved for low risk devices. Moreover, these manufacturers must comply with all Class I requirements including registering with the FDA, listing their MDDS products, reporting adverse events and complying with FDA’s Quality Systems regulation, a basic system of manufacturing and design controls that, among other things, will ensure manufacturers test their products before marketing them.

The rule also levels the playing field for medical device manufacturers. Information technology companies that design, install or market these systems, and hospitals that develop them in their facilities, must follow Class I requirements as well. The Medical Device Data Systems rule is published in the Federal Register (Medical Device Data Systems).

For more information about our expertise in Medical Affairs, contact Dr. Mark L. Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.