Target Health Global

You don’t have to be the biggest, only the best, says Joyce Hays, CEO of Target Health. Target Health has been directly involved with 30 approved products since 1993, including, drugs, devices and biologics. Target Health’s clients come from all over the world including US, Canada, Denmark, France, Germany, Israel, Korea, Switzerland, and the UK. It’s a really interesting experience to come to our offices in NY, now on two floors at 261 Madison Avenue, and see the NY skyline. We have spanned all continents, except Antarctica, with over 200 studies with Target e*CRF® and our employees speak a multitude of languages and represent America’s melting pot. 

For more information about Target Health and our software tools for paperless clinical trials, please contact Dr. Jules T. Mitchel (212-681-2100 ext 0) 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

Oxygen-saturated Blood Reduces Damaged Heart Tissue

Results of a clinical trial published this week in Circulation: Cardiovascular Interventions demonstrate that an infusion of blood that is “supersaturated” with oxygen (SS02) can reduce the amount of damaged heart 1) ___ immediately following a life-threatening heart attack.  “The benefit of this therapy increased with the scope of the 2) ___ attack,” said Gregg W. Stone, M.D., lead author. The data show that heart muscle can be 3) ___ even after severe heart attack. The AMIHOT-II study focused on patients having the most serious types of heart attacks – those with anterior ST-segment elevation myocardial infarctions (STEMIs) – and on patients treated within 6 hours. Of the 733,000 Americans who suffer acute coronary syndromes (i.e. heart attack or chest pain) each year, 361,000 (almost half) have a STEMI, according to the American Heart Association. When a large area of the heart is damaged, heart failure is more likely, and catheter-based percutaneous coronary intervention is a procedure that can effectively open blocked 4) ___ in STEMI patients, Dr. Stone said. In the trial, the “supersaturated” 5) ___ was delivered via catheter directly to the area of the heart muscle affected by the heart attack. The size of the “infarct zone,” or the amount of damaged tissue, was significantly 6) ___ in the patients that received the “supersaturated” oxygen. Data from the study show that the median size of the “infarct zone” was 20% in the patients that received the “supersaturated” blood and 26.5% in the control group. In addition, at 30 days after the treatment a key safety measure — the rates of major adverse cardiac events – were not statistically different between the two groups.

 

ANSWERS:  1) muscle; 2) heart; 3) saved; 4) arteries; 5) oxygen; 6) reduced

Epidemics Bring Out the Worst in Human Behavior

In medieval Europe, Jews were blamed so often, and so viciously, that it is surprising that the Black Death was not called the Jewish Death. During the pandemic’s peak in Europe, from 1348 to 1351, more than 200 Jewish communities were wiped out, their inhabitants accused of spreading contagion or poisoning wells. The swine flu outbreak of 2009 has been nowhere near as virulent, and neither has the reaction. 

But, as in pandemics throughout history, someone got the blame – at first Mexico, with attacks on Mexicans in other countries and calls from American politicians to close the border. In May, a Mexican soccer player who said he was called a “leper” by a Chilean opponent spat on his tormentor; Chilean news media accused him of germ warfare. Dr. Martin J. Blaser, a historian who is chairman of medicine at New York University’s medical school, offers an intriguing hypothesis for why Jews became scapegoats in the Black Death.

His hypothesis is Jews were largely spared, in comparison with other groups, because grain was removed from their houses for Passover, discouraging the rats that spread the disease. The plague peaks in spring, around Passover time. 

But in every pandemic, the chain of causation is intricate. The historian William H. McNeill, author of Plagues and Peoples, suggests that ultimate blame may rest with Mongke Khan, grandson of Genghis, who in 1252 sent his armies as far south as present-day Burma, putting them in contact with rodents whose fleas played host to Yersinia pestis, the plague bacillus. After Yersinia returned with them to the flea-bitten marmots of the Eurasian steppes, it began creeping through the rodent burrows lining Mongol caravan routes, which stretched as far west as the Black Sea. That’s where plague-ridden rats boarded ships in the besieged Crimean port of Kaffa in 1346, taking it to Europe.

Whom in prehistory does one blame for first carrying Yersinia north from its original home in the Great Lakes region of Africa? It is not uncommon for ethnic groups to have religious or cultural customs that protect against disease – but whether it was originally intended to do that or not is often lost in time. Manchurian nomads avoided plague because they believed marmots harbored the souls of their ancestors, so it was taboo to trap them, although shooting them was permitted. But in the early 20th century, trapping by immigrants from China contributed to plague outbreaks.

And Tamils from India working as plantation laborers in Malaysia may have had less malaria and dengue than their Malay and Chinese co-workers did because they never stored water near their houses, leaving mosquitoes no place to breed.

The most visible aspect of blame, of course, is what name a disease gets. The World Health Organization has struggled mightily to avoid the ethnic monikers given the Spanish, Hong Kong and Asian flu, instructing its representatives to shift from swine flu to recently, Pandemic (H1N1) 2009. Dr. Mirta Roses, director of the Pan American Health Organization, said that in the pandemic’s early days, she fought suggestions that it be named the Mexican flu or the Veracruz flu or the La Gloria flu after the country, state and town where it was discovered. We try to avoid demonizing anyone and to keep the focus on the virus, she said. It helps reduce the level of panic and aggression.

When Dr. Roses was a girl, growing up in a small town in Argentina, her neighbors blamed city dwellers for polio. One summer, families took turns with the local police staffing roadblocks to turn back buses from the capital.

By the old naming conventions, the 1918 Spanish flu probably ought to be known as the Kansas flu. According to The Great Influenza: The Epic Story of the Deadliest Plague in History, John M. Barry’s history of the epidemic, the first identifiable cases arose in Haskell County, in Kansas. They soon spread to Fort Riley, from there to other military bases, and then to Europe in troop ships. France, Germany and Britain had war censors controlling news reports. Spain did not get the flu and thus Spain got the blame.

Most human diseases originate in animals. While culling animals sometimes makes sense as a public health measure – for example, culling chickens to stop an outbreak H5N1 avian flu – animals are also sometimes punished pointlessly. In May 2009, the Egyptian government slaughtered thousands of pigs belonging to the Coptic Christian minority, despite international protests. In Afghanistan, Khanzir, the country’s only pig, a curiosity in the Kabul Zoo, was quarantined to keep him away from the goats and deer he had formerly eaten with. And during the spread of the avian flu around Asia, Thailand’s government shot open-billed storks in its cities and chopped down the trees they nested in, even though the flu had not been found in a single stork. Source: The New York Times, 09/01/09

Racial Differences in Survival After In-Hospital Cardiac Arrest

Racial differences in survival have not been previously studied after in-hospital cardiac arrest, an event for which access to care is not likely to influence treatment. As a result, a study published in the Journal of the American Medical Association (2009;302:1195-1201) was performed to 1) estimate racial differences in survival for patients with in-hospital cardiac arrests and 2) examine the association of sociodemographic, clinical factors and the admitting hospital. The investigation was a cohort study of 10,011 patients with cardiac arrests due to ventricular fibrillation or pulseless ventricular tachycardia enrolled between January 1, 2000, and February 29, 2008, at 274 hospitals within the National Registry of Cardiopulmonary Resuscitation. The main outcome measures were survival to hospital discharge and successful resuscitation from initial arrest and post-resuscitation survival (secondary outcome measures). The study population included 1,883 black (18.8%) and 8,128 white patients (81.2%). Rates of survival to discharge were lower for black patients (25.2%) than for white patients (37.4%) (unadjusted relative rate [RR], 0.73. Unadjusted racial differences narrowed after adjusting for patient characteristics (adjusted RR, 0.81; P < .001) and diminished further after additional adjustment for hospital site (adjusted RR, 0.89; P = .002). Lower rates of survival to discharge for blacks reflected lower rates of both successful resuscitation (55.8% vs 67.4% for whites and post-resuscitation survival (45.2% vs 55.5% for whites. Adjustment for the hospital site at which patients received care explained a substantial portion of the racial differences in successful resuscitation and eliminated the racial differences in post-resuscitation survival. According to the authors, black patients with in-hospital cardiac arrest were significantly less likely to survive to discharge than white patients, with lower rates of survival during both the immediate resuscitation and post-resuscitation periods. Sadly, much of the racial difference was associated with the hospital center in which black patients received care.

Propranolol Decreases Tachycardia and Improves Symptoms in the Postural Tachycardia Syndrome (POTS)

Postural orthostatic tachycardia syndrome (often referred to as Postural Tachycardia Syndrome or POTS) is a condition of dysautonomia, and more specifically, orthostatic intolerance, in which a change from the supine position to an upright position causes an abnormally large increase in heart rate, called tachycardia. This is often, but not always, accompanied by a fall in blood pressure. Several studies show a decrease in cerebral blood flow with systolic and diastolic cerebral blood flow (CBF) velocity decreased 44 and 60%, respectively. Patients with POTS have problems maintaining homeostasis when changing position, i.e. moving from one chair to another or reaching above their heads. Many patients also experience symptoms when stationary or even while lying down. Symptoms present in various degrees of severity depending on the patient. POTS is a serious, though non-life threatening, medical condition that can be severely disabling and debilitating. Some patients are unable to attend school or work, and especially severe cases can completely incapacitate the patient. ?-Blockade is an appealing treatment approach, but conflicting preliminary reports are conflicting. As a result, a study published in Circulation (2009;120:725-734), was performed to test the hypothesis that propranolol will attenuate the tachycardia and improve symptom burden in patients with POTS. In study 1, patients with POTS (n=54) underwent acute drug trials of propranolol (20 mg) and placebo, on separate mornings, in a randomized crossover design. Blood pressure, heart rate, and symptoms were assessed while the patients were seated and after standing for up to 10 minutes before and hourly after the study drug. Supine (P<0.001) and standing (P<0.001) heart rates were significantly lower after propranolol compared with placebo. The symptom burden improvement from baseline to 2 hours was greater with propranolol than placebo (P=0.044). In study 2, 18 patients with POTS underwent similar trials of high-dose (80 mg) versus low-dose (20 mg) propranolol. Although the high dose elicited a greater decrease than the low dose in standing heart rate (P<0.001) and orthostatic tachycardia (P<0.001), the improvement in symptoms at 2 hours was greater with low-dose propranolol (P=0.041). According to the authors, low-dose oral propranolol significantly attenuated tachycardia and improved symptoms in POTS and that higher-dose propranolol did not further improve, and may worsen, symptoms.

VI. OPHTHALMOLOGY

New Treatment Found To Reduce Vision Loss From Central Retinal Vein Occlusion (CRVO)

 

In the US, vein occlusion is estimated to be the second most common condition affecting blood vessels in the retina. Currently, no treatment exists for central retinal vein occlusion (CRVO), in which a blood clot slows or stops circulation in a large vein within the eye’s light-sensitive retinal tissue. Reduced retinal circulation can lead to new blood vessel growth and blood vessel leakage, which results in retinal tissue swelling — a common cause of vision loss from CRVO. Until now, there has been no proven, effective way to treat CRVO. However, some ophthalmologists have treated patients with eye injections of an anti-inflammatory corticosteroid called triamcinolone, though its effectiveness had not been tested in a clinical trial. According to a report from the National Eye Institute (NEI) at the National Institutes of Health, a multi-center, Phase III clinical trial has identified the first long-term, effective treatment to improve vision and reduce vision loss associated with blockage of large veins in the eye. The Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE) Study, conducted at 84 clinical sites, found that eye injections of triamcinolone could reduce vision loss related to CRVO. Treated patients were also five times more likely to gain vision after one year than patients who were just under observation. The SCORE Study was the first to compare the safety and effectiveness of standard care observation with two different dosages of triamcinolone: 1 mg and 4 mg. The results appear in the Archives of Ophthalmology (2009;127:1101-1114), which was published alongside findings from a separate trial within the SCORE Study, which looked at blockages in smaller retinal veins. Study participants included 271 people with CRVO who were an average of 68 years old. Patients in the treatment group could receive a maximum of three corticosteroid injections every year for up to three years, based on the state of their disease. At one year, patients who received either dose of the corticosteroid medication were five times more likely than those who did not receive treatment to experience a substantial visual gain of three or more lines on a vision chart-equivalent to identifying letters that were half as small as they could read before treatment. However, patients in the 1 mg group had fewer side effects related to increased eye pressure and cataract formation than those in the 4 mg group.

TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available.

FDA Announces Second Annual Science Writers Symposium

Science is a key foundation for the decisions FDA makes daily on a wide-range of products affecting human and animal health – from the most common food ingredients, to complex medical and surgical devices, to lifesaving drugs. The Second Annual Science Writers Symposium on Nov. 4 and 5, 2009, which will be held at the FDA’s White Oak campus in Silver Spring, Md., will highlight how the FDA applies novel scientific approaches to critical public health issues and the products it regulates. The symposium, featuring a lab tour and presentations by FDA scientists, will give writers a unique insight into the evolving field of regulatory science with an eye towards generating potential story ideas.

Information on the speakers and agenda will be posted soon at: http://www.fda.gov/ScienceResearch/MeetingsConferencesandWorkshops/ScienceWritersSymposium/default.htm.

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 1) Target e*CRF® (EDC plus randomization and batch edit checks), 2) Target e*CTMSTM, 3) Target Document®, 4) Target Encoder®, 5) Target Newsletter®, 6) Target e*CTRTM (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.

Serious HealthCare Issues – Part One

Former Cigna VP Speaks Out

Serious HealthCare Issues – Part Two

Former Cigna VP Speaks Out