Science Weekly: The ‘immortal’ Henrietta Lacks

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Rebecca Skloot tells us about the intriguing story of Henrietta Lacks; and an interview with British astronaut Tim Peake

Good Week for Target Health Clients – EDC Approval for an HIV Diagnostic and Panel Approval for ellaOne

Target Health is pleased to announce the PMA approval of Abbott ARCHITECT HIV Ag/Ab Combo, which is indicated as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. Target e*CRF® was used for this program and the PMA was approved in 6 months. This is the 19th unique product that has been approved by FDA/EMA that used Target e*CRF for EDC. Two other drug approvals are expected this year.

Target Health congratulates HRA Pharma for the unanimous advisory panel approval of ulipristal acetate (ellaOne) for the treatment of emergency contraception. For this program, Target e*CRF® was used for the two pivotal trials.  Target Health monitored one of the pivotal trials performed in the US and performed the statistical analyses.  Target Health wrote the study reports and was the FDA agent for the IND. The committee’s vote followed a review of data from the preclinical program and the clinical development program involving more than 4,000 women from the U.S. and Europe. Ulipristal acetate was approved in May 2009 by the European Commission.

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

Circadian Clock in Pancreas Directly Linked to Diabetes

The pancreas has its own molecular 1) ___. Now, for the first time, a Northwestern University study has shown this ancient circadian clock regulates the production of insulin. If the clock is faulty, the result is diabetes. The researchers show that insulin-secreting islet cells in the 2) ___, called beta-cells, have their own dedicated clock. The clock governs the rhythmic behavior of proteins and genes involved in insulin secretion, with oscillations over a 24-hour cycle. The findings, which were published June 18 in the journal Nature, shine a light on a system that hasn’t been recognized as having a strong effect on the process of 3) ___ homeostasis. “This is the first evidence of how the circadian clock may affect the development of diabetes,” said Joe Bass, M.D., Associate Professor of Medicine at the Feinberg School of Medicine and of Neurobiology and Physiology at the Weinberg College of Arts and Sciences. “The biological programs in animals for harvesting energy — much like the 4) ___ of plants — are under control of the clock. Our findings will help us figure out the causes of glucose abnormalities, but we still have a lot to learn.” In the study, the researchers knocked out the clock genes in islet beta-cells in mice and found the animals developed impaired glucose tolerance and abnormally low levels of 5) ___ and went on to develop diabetes. The clock of the beta-cell coordinates glucose management, and the loss of the clock inhibited the cells from secreting insulin. The variation that is seen in insulin secretion in humans and susceptibility to 6) ___ is likely related to this clock mechanism. There is also an association in the changes of the cycling of the clock within the pancreas itself and disease. The next question is, can this be modulated?” By isolating the pancreas and using bioluminescence imaging (which relies on a protein found in the firefly), the researchers determined that a circadian clock is expressed autonomously in the pancreas. The visual proof is shown in a short video they produced of the beating clock in live insulin-producing cells of the pancreas. The cells emitted light once every 24 hours over a sustained period of time. “It’s important to remember that body clocks are ancient mechanisms that regulate fundamental biological 7) ___ important to health, such as insulin secretion, the time we go to bed, the time we get up and the time we get hungry,“ Bass said. The body’s primary circadian clock resides deep in the 8) ___, in the suprachiasmatic nuclei, but local biological clocks also are found in tissues throughout the body, including the pancreas, lungs, liver, heart and skeletal muscles. The clocks operate on a 24-hour, circadian (Latin for “about a day“) cycle that governs functions such as sleeping and waking, rest and activity, fluid balance, body temperature, cardiac output, oxygen consumption, metabolism and endocrine gland secretion. The impact of diabetes on health and economics is sobering. According to the American Diabetes Association, more than 23 million adults and children in the United States have a form of diabetes, and at least 57 million have prediabetes; the total cost of diagnosed diabetes (medical costs as well as disability, work loss and early death) is at least $174 billion; and diabetes is the seventh-leading cause of 9) ___ in the country.

ANSWERS: 1) clock; 2) pancreas; 3) glucose; 4) photosynthesis; 5) insulin; 6) diabetes; 7) systems; 8) brain; 9) death

Herbs

Wild herbs were used as healing remedies long before records were kept. Otzi, the 5,300-year-old Iceman found in the Alps in 1991, had medicinal mushrooms among his personal effects, and herbs have been an integral part of Eastern medicine for centuries. Today modern medicine is beginning to realize that herbs may ease the symptoms of many ailments, from the common cold to arthritis, because they contain important health-promoting compounds such as antioxidants and anti-inflammatories. Listed here are five healthy and gentle herbs that have been used for centuries. Peppermint was first cultivated near London in 1750, and used as an effective remedy for indigestion. Peppermint appears to calm the muscles of the digestive tract to alleviate intestinal gas and cramping. It has been used to settle the stomach and to ease muscle cramps. Arab doctors in the 9th and 10th centuries called lemon balm the gladdening herb and prescribed it to dispel anxiety and heart palpitations. More recently, a panel of physicians, pharmacologists, and scientists appointed by the German Ministry of Health endorsed the herb for relieving tension, anxiety, and restlessness. There’s also evidence of cognitive benefits. In a small study published in Neuropsychopharmacology, 20 healthy young adults reported increased memory and improved mood after ingesting lemon balm. Another study found similar results among Alzheimer’s patients. The use of rosemary as a memory enhancer dates back at least to early Western civilization. Greek students wore garlands of rosemary around their heads, and students in Rome massaged their temples and foreheads with the herb prior to exams. Rosemary was also used to reduce joint pain. Rosemary needles were soaked in almond oil for two weeks, filtered, and then rubbed onto sore joints as needed. Valerian has been used throughout history as a sedative and sleep aid, valerian gets its name from the Latin valere, which means “to be in good health.“ “Just the smell alone of the sweetly scented plant is enough to relax some people. As an aid to sore throats, sage leaves were mixed with hot water and taken as a tea, and/or a gargle. Sage was also used to freshen breath. At the end of most days, 81-year-old botanist Dr. Jim Duke pours himself a cocktail. Hardly a Scotch on the rocks, this healthy concoction he’s aptly dubbed Creme d’Mentia is a blend of herbs, steeped in diluted vodka, that are thought to boost relaxation, mood, memory, and overall brain health. “It lifts my spirits and lowers my anxiety,“ says Duke, who worked for the U.S. Department of Agriculture for 30 years and is the author of The Green Pharmacy book series. If you want Duke’s special cocktail recipe, please contact Joyce Hays.

Effectiveness of Rotavirus Vaccination Against Childhood Diarrhea in El Salvador

According to an article published in the British Medical Journal (2010;340:2825), a study was performed to evaluate the effectiveness of a monovalent rotavirus vaccine against severe rotavirus disease and to assess its impact on diarrhea in children aged less than 2 years after national introduction in El Salvador, a low-middle income country in Central America. The study took place in seven hospitals in cities across El Salvador between January 2007 and June 2009. Study participants included 323 children aged less than 2 years admitted with laboratory confirmed rotavirus diarrhea and 969 healthy controls matched for age and neighborhood. The main outcome measure was effectiveness of rotavirus vaccination against rotavirus diarrhea requiring hospital admission. Cases and controls were similar for breast feeding, premature birth, maternal education, and socioeconomic variables. G1P[8] strains were identified in 92% of rotavirus cases. Effectiveness of two doses of vaccination against diarrhea requiring hospital admission was 76%. Protection was significantly lower (P=0.046) among children aged 12 months or more (59%) compared with children aged 6-11 months (83%). One dose of vaccine was 51% effective. At the sentinel hospitals, all admissions for diarrhea among children under 5 declined by 40% in 2008 and by 51% in 2009 from the prevaccine year 2006. According to the authors, a monovalent rotavirus vaccine was highly effective against admissions for rotavirus diarrhea in children aged less than 2 years and substantially reduced the number of such admissions. The authors added that the impact on disease epidemiology after vaccination, particularly among older children, warrants future attention.

Effect of High-Dose Allopurinol on Exercise in Patients with Chronic Stable Angina: A Randomized, Placebo Controlled Crossover Trial

Allopurinol, an inexpensive generic drug, is a structural isomer of hypoxanthine (a naturally occurring purine in the body) and is an enzyme inhibitor, inhibiting xanthine oxidase. Xanthine oxidase is responsible for the successive oxidation of hypoxanthine and xanthine resulting in the production of uric acid, the product of human purine metabolism. In addition to blocking uric acid production, inhibition of xanthine oxidase causes an increase in hypoxanthine and xanthine, which are converted to closely related purine ribotides adenosine and guanosine monophosphates. Increased levels of these ribotides causes feedback inhibition of amidophosphoribosyl transferase, the first and rate-limiting enzyme of purine biosynthesis. Allopurinol therefore decreases both uric acid formation and purine synthesis. Experimental evidence suggests that xanthine oxidase inhibitors can reduce myocardial oxygen consumption for a particular stroke volume. If such an effect also occurs in man, this class of inhibitors could become a new treatment for ischemia in patients with angina pectoris. As a result, a study published The Lancet, Early Online Publication (8 June 2010), was performed to determine whether high-dose allopurinol prolongs exercise capability in patients with chronic stable angina. For the study, 65 patients (aged 18-85 years) with angiographically documented coronary artery disease, a positive exercise tolerance test, and stable chronic angina pectoris (for at least 2 months), were recruited into a double-blind, randomized, placebo-controlled, crossover study. Patients were randomly assigned to either allopurinol (600 mg per day) or placebo for 6 weeks. The primary endpoint was the time to ST depression*, and the secondary endpoints were total exercise time and time to chest pain. In the first treatment period, 31 patients were allocated to allopurinol and 28 were analyzed, and 34 were allocated to placebo and 32 were analyzed. In the second period, all 60 patients were analyzed. Results showed that allopurinol increased the median time to ST depression to 298 seconds from a baseline of 232 seconds, compared to 249 seconds for placebo (p=0?0002). Allopurinol increased median total exercise time to 393 seconds from a baseline of 301 seconds compared to 307 seconds for placebo (p=0?0003). Allopurinol also increased the time to chest pain from a baseline of 234 seconds to 304 seconds compared to 272 seconds for placebo (p=0?001). No adverse effects of treatment were reported. The authors concluded that allopurinol seems to be a useful, inexpensive, well tolerated, and safe anti-ischemic drug for patients with angina.

* ST Depression – It may represent electrolyte abnormality, repolarization abnormality or ischemia.Hepatic ischemia
Ischemic colitis
Mesenteric artery ischemia
Testicular torsion
Vertebrobasilar circulatory disorders  It is measured 80 msec after the j point of the QRS segment on an EKGAtrioventricular block, ekg tracing
Ecg
Exercise stress test. It unfortunately does not usually localize the ischemia.Hepatic ischemia
Ischemic colitis
Mesenteric artery ischemia
Testicular torsion
Vertebrobasilar circulatory disorders …The
Cleveland Clinic

The Prevalence of Age-Related Macular Degeneration and Associated Risk Factors

Age related macular degeneration (AMD) is a medical condition which usually affects older adults which, because of damage to the retina, results in a loss of vision in the center of the visual field (the macula). AMD occurs in “dry“ and “wet“ forms. It is a major cause of visual impairment in older adults (>50 years). AMD can make it difficult or impossible to read or recognize faces, although enough peripheral vision remains to allow other activities of daily life. According to an article published in Archives of Ophthalmology (2010;128:750-758), a study was performed to determine the prevalence of age-related macular degeneration (AMD) and to examine how retinal drusen, retinal pigmentary abnormalities, and early AMD are related to age, gender and other risk factors. Study participants included a total of 2,810 people aged 21 to 84 years participating in the Beaver Dam Offspring Study. The presence and severity of various characteristics of drusen and other lesions typical of AMD were determined by grading digital color fundus images using the Wisconsin Age-Related Maculopathy Grading System. Results showed that early AMD was present in 3.4% of the cohort and varied from 2.4% in those aged 21 to 34 years to 9.8% in those aged 65 years or older. In a multivariable model, the odds ratios were as follows: age (per 5 years of age, 1.22), being male (1.65), more pack-years of cigarettes smoked (1-10 vs 0, 1.31; 11 vs 0, 1.67), higher serum high-density lipoprotein cholesterol level (per 5 mg/dL, 0.91), and hearing impairment (2.28) were associated with early AMD. There were no associations of blood pressure level, body mass index, physical activity level, history of heavy drinking, white blood cell count, hematocrit level, platelet count, serum total cholesterol level, or carotid intimal-medial thickness with early AMD. According to the authors, the data indicate that early AMD is infrequent before age 55 years but increases with age thereafter, and that early AMD is related to modifiable risk factors, e.g., smoking and serum high-density lipoprotein cholesterol level.

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

Health Reform Update/Nixing the “Doc Fix“ by a Target Health Doc

Lest any of our readers believe that the nation’s health care problems have been solved by passage of the Health Care Reform Bill (Patient Protection and Affordable Health Care Act), the ongoing legislative dance to secure relief from physician pay cuts mandated by the SGR (sustainable growth rate) legislation linking Medicare reimbursement to GDP growth offers a dose of reality. This linkage mandates cuts in Medicare reimbursement when spending exceeds defined GDP based limits; since passage, relief from these mandatory cuts has been granted through a series of temporary legislative “fixes“. The AMA campaigned vigorously for a permanent solution as a component of health care reform, but the cost was prohibitive and the dance of periodic “fixes“ continues. As On-Target goes to press, the latest legislative fix first failed to pass the Senate (confronting physicians with a 21% reduction in reimbursement) and then, after urgent negotiations, passed in revised form. This fix must now return to the House. Pending final passage (presumably) next week, claims will be processed at the reduced rate, potentially damaging medical practices with fixed costs yet undiminished responsibility, to provide critical services to Medicare patients.

On-Target predicts that the House will pass the new “fix“, kicking the proverbial “can down the road“ for another six months, but this is – euphemistically – no way to run a railroad (or any other critical enterprise for that matter). One takeaway, (among many) is that the voluminous health reform legislation recently passed is, to paraphrase Winston Churchill, not the end, not the beginning of the end, but perhaps the end of the beginning. There are thousands of pages of implementing rules to be written and, as is evidenced by this “doc-fix“ scenario, fundamental issues of quality, access, and cost remain unresolved. The key takeaway: we in healthcare will be managing through uncertainty for some time.  By Mark L. Horn MD, MPH, Chief Medical Officer of Target Health Inc.

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, Management of Clinical Trials, Biostatistics, Data Management, EDC utilizing Target e*CRF®, Project Management, and Medical Writing.

Target Health has developed a full suite of eClinical Trial software including:

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2) Target e*CTMS™,

3) Target Document®,

4) Target Encoder®,

5) Target Newsletter®,

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

Target Health ‘s Pharmaceutical Advisory Dream Team assists companies in strategic planning from Discovery to Market Launch. Let us help you on your next project.

 


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