Science Weekly: Why you should distrust your senses

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Our fallible senses; newly reunited footage and audio of Apollo 11 mission control; plus, how comics are being used in medicine

Target Encoder Version 1.4 Being Released This Month

 

Target Health Inc. is pleased to announce that Target Encoder™ Version 1.4 is being released this month. Target Encoder is fully web-based and has been developed with several of our top EDC clients to facilitate their ability to code to MedDRA and WHO DRUG when using Target e*CRF®. Target Encoder Version 1.4 has many new features and is not limited to Target e*CRF EDC users.

Target Health is committed to provided cost effective and user-friendly software to our CRO partners and the pharmaceutical industry. Target Health software products include Target e*CRF, Target Document®, Target Encoder, Target e*CTMS®, Target Newsletter™ and Target e*CTR®, the eClinical Trial Record.

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

Stem Cells from Surgery Leftovers Could Repair Damaged Hearts

 

For the first time, it has been possible to extract vital stem cells from sections of vein removed for heart bypass surgery. These stem cells have been shown to stimulate new blood vessels to grow, which could potentially help repair damaged heart 1) ___ after a heart attack.

The research, by Paolo Madeddu, Professor of Experimental Cardiovascluar Medicine and his team in the Bristol Heart Institute (BHI) at the University of Bristol, is published in the journal Circulation.

Around 20,000 people each year undergo heart bypass surgery. The procedure involves taking a piece of vein from the person’s leg and grafting it onto a diseased coronary artery to divert 2) ___ around a blockage or narrowing. The surgeon normally takes out a longer section of vein than is needed for the 3) ___. The Bristol team successfully isolated stem cells from leftover veins that patients had agreed to donate.

In tests in mice, the cells proved able to stimulate new blood 4) ___ to grow into injured leg muscles. Professor Madeddu and his team are now beginning to investigate whether the cells can help the heart to recover from a heart attack. “This is the first time that anyone has been able to extract stem cells from sections of 5) ___ left over from heart bypass operations,” Professor Madeddu said. Madeddu added that “These cells might make it possible for a person having a bypass to also receive a heart treatment using their body’s own stem cells and the if we can also multiply these cells to make millions more stem cells, these cells  could potentially be stored in a 6) ___ and used to treat thousands of patients.”

Professor Peter Weissberg, Medical Director of the BHF, said: “Repairing a damaged heart is the holy grail for heart patients. The discovery that cells taken from patients’ own blood vessels may be able to stimulate new blood vessels to grow in damaged tissues is a very encouraging and important advance. It brings the possibility of “cell therapy” for damaged hearts one step closer and, importantly, if the chemical messages produced by the 7) ___ can be identified, it is possible that drugs could be developed to achieve the same end.”

ANSWERS: 1) muscle; 2) blood; 3) bypass; 4) vessels; 5) vein; 6) bank; 7) cells

Diphtheria

 

Until the late 19th century, diphtheria was a gruesome killer with no known cause and many ineffective treatments. In 1874, The New-York Times printed an advertisement for a medicine that would cure not only diphtheria, but also corns, bunions and “pains in the loins and back.” The same year, a news article began, “There has been spreading for some time an idea or hypothesis among the more philosophic medical men, and among the thoughtful ‘laity,’ that many species of disease have their sources in, and are scattered by, seeds or germs.”

But it was December 7, 1890, before The Times first hinted there might be a real cure for diphtheria. That day a Page 1 article about events in Germany reported that “Drs. Behring and Kitasato found that the blood of immune rats and mice had a destructive effect on the virus of diphtheria.” The reporter was apparently unaware that diphtheria is caused by a bacterium, not a virus, but in any case the treatment was as destructive to humans as it was to the germ. The article went on to report that two human patients transfused with the animals’ blood almost immediately dropped dead.

But progress was fast. On October 1, 1894, a headline on Page 2 read “Repression in the Reichstag,” over a story about European politics. In the ninth paragraph the anonymous reporter changed subjects. “A congress of German naturalists and physicians opened its sessions in Vienna on Monday,” he wrote, and then went on to discuss Emil von Behring’s “discovery of a cure for diphtheria by the inoculation of the patient with serum blood.”

On November 26, 1894, The Times reported that Behring’s “diphtheria anti-toxine” had been commercially imported for the first time, and a lengthy description of the substance and its manufacture appeared on December 9, 1894. That same day a brief article on Page 10 reported that in a diphtheria epidemic in New Rochelle, N.Y., “there have been several quick cures by the use of antitoxine, the new remedy, and the new cases will be treated with it.” By this time, serum was being produced from horse blood in New York City.

In the spring of 1913, Behring developed a vaccine against diphtheria. On May 15, 1914, a short article reported that the French newspaper Le Matin had declared the serum one of “the Seven Wonders of the modern world.” The other six were “the aeroplane, wireless, radium, the locomotive, human grafting and the dynamo.” The vaccine was not widely distributed until the 1920s. On March 13, 1921, a Page 14 headline read “Begins Work to End Diphtheria Here.”

Today’s vaccine, recommended for all infants and for adults who have not been immunized, is manufactured by treating the diphtheria toxin with heat and chemicals, destroying its ability to produce disease but allowing it to stimulate the production of antibodies. Because the vaccine is so effective and so widely used, diphtheria is rare in industrialized countries, but when it does occur it can be treated with diphtheria antitoxin.

In the United States, the medicine is available only through the Centers for Disease Control and Prevention, which imports it from Brazil, one of the few countries in the world that still manufactures it. By Nicholas Bakalar for The New York Times   

Hyperthermia and Heat-Related Illness Advice for Older People

 

The National Institute on Aging (NIA), part of the National Institutes of Health, is providing advice for helping older people avoid heat-related illnesses, known as hyperthermia.

Hyperthermia is an abnormally high body temperature caused by a failure of the heat-regulating mechanisms of the body to deal with the heat coming from the environment. Heat fatigue, heat syncope (sudden dizziness after prolonged exposure to the heat), heat cramps, heat exhaustion and heat stroke are commonly known forms of hyperthermia. Risk for these conditions can increase with the combination of outside temperature, general health and individual lifestyle.

Lifestyle factors can include not drinking enough fluids, living in housing without air conditioning, lack of mobility and access to transportation, overdressing, visiting overcrowded places and not understanding how to respond to hot weather conditions. Older people, particularly those with chronic medical conditions, should stay indoors on hot and humid days, especially when an air pollution alert is in effect. People without air conditioners should go to places such as senior centers, shopping malls, movie theaters or libraries. Cooling centers, which may be set up by local public health agencies, religious groups and social service organizations in many communities, are another option.

Health-related factors that may increase risk include:

  • Being dehydrated.
  • Age-related changes to the skin such as poor blood circulation and inefficient sweat glands.
  • Heart, lung and kidney diseases, as well as any illness that causes general weakness or fever.
  • High blood pressure or other conditions that require changes in diet. For example, people on salt-restricted diets may increase their risk. However, salt pills should not be used without first consulting a doctor.
  • Reduced perspiration, caused by medications such as diuretics, sedatives, tranquilizers and certain heart and blood pressure drugs.
  • Taking several drugs for various conditions. It is important, however, to continue to take prescribed medication and discuss possible problems with a physician.
  • Being substantially overweight or underweight.
  • Drinking alcoholic beverages.

 

Heat stroke is a life-threatening form of hyperthermia. It occurs when the body is overwhelmed by heat and unable to control its temperature. Someone with a body temperature above 104 degrees Fahrenheit is likely suffering from heat stroke and may have symptoms of confusion, combativeness, strong rapid pulse, lack of sweating, dry flushed skin, faintness, staggering, possible delirium or coma. Seek immediate emergency medical attention for a person with any of these symptoms, especially an older adult.

If you suspect that someone is suffering from a heat-related illness:

— Get the person out of the sun and into a shady, air-conditioned or other cool place. Urge them to lie down.

— If you suspect heat stroke, call 911.

— Encourage the individual to shower, bathe or sponge off with cool water.

— Apply a cold, wet cloth to the wrists, neck, armpits, and/or groin, places where blood passes close to the surface of the skin, and the cold cloths can help cool the blood.

— Offer fluids such as water, fruit and vegetable juices, but avoid alcohol and caffeine.

For a free copy of the NIA’s AgePage on hyperthermia in English or in Spanish, contact the NIA Information Center at 1-800-222-2225 or go to <http://www.niapublications.org/agepages/hyperther.asp> or <www.niapublications.org/agepages/hyperther-sp.asp> for the Spanish-language version.

Genetics

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Gene Associated with Rare Adrenal Disorder Appears to Trigger Cell Death

The adrenal glands – one located on top of each kidney – produce hormones which help control heart rate, blood pressure, and other important body functions.

Carney complex is a rare disorder of the adrenal glands. Individuals with Carney complex typically develop Cushing’s syndrome, a combination of weight gain, high blood pressure, diabetes, and other symptoms stemming from the overproduction of the hormone cortisol, which is produced by the adrenal glands. People with Carney complex are also predisposed to developing benign tumors of the heart and connective tissue, as well as benign and cancerous tumors of the adrenal and other glands. Previous studies have shown that people with Carney complex are likely to have a mutation in the Prkar1a gene.

According to a study published online in PLoS Genetics (June 2009), a gene implicated in Carney complex appears to function as a molecular switch to limit cell growth and division. The study observed that the normal process by which cells in the adrenal gland grow old and die is put on hold when the gene, known as Prkar1a, is deactivated. The Prkar1a gene is known to be involved in how the cell regulates its activities.

In order to conduct the study, the authors developed a strain of mice lacking functional copies of the Prkar1a gene in the adrenal glands. As the mice grew, they developed characteristics similar to those of people with Carney complex, including Cushing’s syndrome. According to the authors, the study results suggest that in adrenal tissue, the Prkar1a protein ensures that normal hormone-producing functions develop. In mice with functioning copies of Prkar1a, stem cells in the adrenal glands are retained after birth in a region of the gland called the X-zone. This zone disappears when female mice have their first litter, or at puberty in males. However, among mice lacking the Prkar1a gene, 10-month-old females that had given birth still retained the stem-cell-like X-zone tissue. This zone was even larger in 18-month-old mice.

In other sections of the gland, the study detected new stem cell-like cells in 5-month-old mice. These cells grew in a band that was progressively thicker in 10- and 18-month-old mice. The findings suggest that the Prkar1a protein plays a role in curtailing the further growth and development of these stem cells into tumors. According to the authors, it is possible that mutations in Prkar1a play a role in the development of other kinds of tumors as well. In a previous study, it was found that mice with disruptions in the Prkar1a gene developed bone tumors. According to the authors, these studies also may have important implications in understanding how unregulated stem cells may lead to tumor development in various organs.

Paternal Smoking and Childhood Overweight: Evidence From the Hong Kong “Children of 1997”

According to an article published in Pediatrics (2010;126:e46-e56), a study was performed to examine, in a non-Western sociohistorical context, whether prenatal or postnatal secondhand smoke (SHS) of nonsmoking mothers was associated with higher childhood BMI, and whether the observed associations were biologically mediated or socioeconomically confounded.

The analysis included a total of 6,710 and 6,519 children of nonsmoking mothers (N = 7924) with BMI data at 7 and 11 years, respectively. The overall population included 8,327 children from the Hong Kong Chinese birth cohort (“Children of 1997”), born in April or May 1997. Results showed that compared with no SHS exposure, daily paternal smoking increased mean BMI z scores, but not height, at 7 years (difference: 0.10) and at 11 years (difference: 0.16), with adjustment for gender, birth order, socioeconomic position, mother’s place of birth, breastfeeding, serious morbidity, and pubertal status.

According to the authors, the findings, although preliminary, suggest that the association of paternal smoking with child overweight might be biologically mediated and that given the known harms of smoking, reducing SHS exposure from conception as a precautionary action for childhood overweight might be warranted.

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

FDA Seeks Public Comment on New Federal Menu Labeling Requirements

 

The FDA has announced that it is inviting the public to submit comments and information to help the agency implement a new federal law that requires the posting of calorie content and other nutrition information on menu items at certain chain restaurants and similar retail food operations and vending machines. The new law, Section 4205 of the Affordable Care Act signed into law March 23, 2010, sets new federal requirements for foods sold at certain restaurants, coffee shops, delis, movie theaters, bakeries, ice cream shops, and in vending machines.

Prior to the new law, federal law required nutrition labeling on many packaged foods, which may be purchased in supermarkets and at other locations, and some states and local governments required nutritional labeling by restaurants in their jurisdictions. The new law requires restaurants and similar retail food establishments that are part of a chain with 20 or more locations that offer substantially the same menu items to list calorie content information on menus and menu boards, including drive-through menu boards.

Other nutrition information – total calories, total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein – must be made available in writing on request. The act also requires vending machine operators who own or operate 20 or more vending machines to disclose the calorie content of their items.

The FDA is required by law to issue proposed regulations to carry out these provisions by March 23, 2011. The agency also expects to issue guidance concerning the requirements of Section 4205 of the Affordable Care Act. The FDA encourages members of the food industry, state and local governments, consumers, and other interested parties to offer comments and suggestions about menu labeling in docket number FDA-2010-N-0298. The docket was officially opened for comments on July 7, 2010 and will remain open for 60 days.

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

Target Health (www.targethealth.com) is a full service eCRO with full-time staff dedicated to all aspects of drug and device development. Areas of expertise include Regulatory Affairs, comprising, but not limited to, IND (eCTD), IDE, NDA (eCTD), BLA (eCTD), PMA (eCopy) and 510(k) submissions, execution of Clinical Trials, Project Management, Biostatistics and Data Management, EDC utilizing Target e*CRF®, and Medical Writing.

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1) Target e*CRF® (EDC plus randomization and batch edit checks)

2) Target e*CTMS™

3) Target Document®

4) Target Encoder®

5) Target Newsletter®

6) Target e*CTR™ (electronic medical record for clinical trials).

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