How are the conditions where you live?
By Francie Diep



Air Pollution Deaths Around The World Earth Observatory image by Robert Simmon based on data provided by Jason West



You’ve probably seen those photos of Beijing on a bad pollution day. Such days come and go, but the effects of even small amounts of increased pollution may linger in a population for a long time. Several studies have established that different air pollutants reduce people’s lifespans.

In a new study, a team of international scientists estimated how many people die each year from the effects of air pollution all over the world. This map shows their numbers.

The map’s colors don’t actually show absolute numbers of deaths. Instead, they say how many more people in a region died from air pollution in 2000 than in 1850. The colors indicate the number of increased deaths per 386 square miles, an area about the size of Dallas. That means that in the worst parts of northern China and India, there are now 1,000 more deaths from air pollution per Dallas-sized area than there were in 1850.

There are a few places around the world in which air conditions were better in 2000 than they were in 1850. One big improved patch includes the U.S.’s southeastern states, where Antebellum farmers used to burn vegetation to clear the ground, throwing a lot of particulate matter into the air. Improved areas in India and Africa are likely due to climate change, which can alter the rate at which different chemical reactions occur in the air and how the atmosphere circulates.

October Conference on Risk-Based Monitoring in Clinical Research


Hot off the press.  FDA Issues Final eSource Guidance. We are very pleased that our eSource solution fully complies with the letter and spirit of the Guidance.  See Regulatory Affairs Below.


Target Health will be presenting at a meeting on Industry Models for Implementing FDA Guidance and Reducing Source Data Verification. The presentation will address Leveraging Risk-Based Monitoring and Direct Data Entry to Assess Quality Metrics in Real-Time. The meeting will be held at the Sonesta Hotel, Philadelphia, PA (October 24-25, 2013).


The following summarizes the presentation: The combination of risk-based monitoring and direct data entry (DDE) results in a significant increase in the efficiency of clinical trial operations while reducing overall monitoring costs and expediting the delivery of safe and effective drugs to the market. The case study shares the considerations and processes employed by Target Health during their implementation of a risk-based approach.


Utilization of Target e*CTR (eClinical Trial Record; eSource) and centralized monitoring permits sponsors to review data in “real time”. This capability is transformative, and among the benefits are:


1. Real time access to patient safety issues
2. Ability to assess knowledge of the protocol by the clinical sites and CRA
3. Reduction of protocol violations since data errors are not languishing on a piece of paper after the patient is already treated
4. Reduction in errors and queries since the data are not being transcribed
5. Reduction of most SDV except what is to be performed during chart review
6. Ability to modify the EDC system quickly before the generation the same query multiple times for the same event


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.

Heart Disease & Stroke Risk Factors




Your heart is an amazing powerhouse that pumps and circulates blood each minute, through your entire body.


We’re all at risk for heart disease and stroke. However, certain groups – including African Americans and 1) ___ individuals – are at higher risk than others. With 1.5 million heart attacks and strokes happening every year in the United States, it’s important to know the risks.


Heart Disease and Age

Many people mistakenly think of heart disease and 2) ___ as conditions that only affect older adults. However, a large number of younger people suffer heart attacks and strokes. About 150,000 people who died from cardiovascular disease in 2009 were younger than age 65.


Heart Disease and Race

3) ___ disease remains the leading cause of death in the United States for adults of all races. However, there are big differences in the rates of heart disease and stroke between different racial and ethnic groups. Some minority groups are more likely to be affected by heart disease and stroke than others – which contributes to lower life expectancy found among minorities. As of 2007, African American men were 30% more likely to die from heart disease than were non-Hispanic white men. African American adults of both genders are 40% more likely to have high blood pressure and 10% less likely than their white counterparts to have their blood pressure under control. African Americans also have the highest rate of high blood pressure of all population groups, and they tend to develop it 4) ___ in life than others.


Heart Disease and Gender

Heart disease is the leading cause of death for American women, killing nearly 422,000 each year. Following a heart 5) ___, approximately 1 in 4 women will die within the first year, compared to 1 in 5 men.


Heart Disease and Income

Men and women of all economic backgrounds are at risk for heart disease and stroke. However, individuals with low 6) ___ are much more likely to suffer from high blood pressure, high cholesterol, heart attack, and stroke than their high-income peers. This discrepancy is due to numerous factors, including early life environment, quality of health education, availability of nutritious 7) ___, proximity to recreational facilities, cultural and financial barriers to seeking treatment, and accessibility of cardiovascular care.


Heart Disease and Behavioral Health

Depression has been found to be a risk factor for development of heart disease. Depression occurs in up to 20% of people with heart disease, and has been found to be a 8) ___ factor also for subsequent heart attack, the need for cardiac procedures, hospitalization, and mortality. Fortunately, depression in patients with heart disease responds well to treatment with either medication or counseling. Additionally:


  • People with severe mental disorders are 25% to 40% more prone to die from heart disease than the general population.
  • Over 80% of individuals with serious mental illness are overweight or obese, contributing to them dying at three times the rate of the overall population.
  • 75% of individuals with behavioral health problems smoke cigarettes, as compared to 23% of the general 9) ___.
  • Half of all deaths from smoking occur among individuals with mental and substance use disorders.
  • New research (As of March 26, 2013) suggests that mental health may play a bigger role in whether a patient dies from heart disease or not. The study, published in the Journal of the American Heart Association, found that depression and anxiety considerably raise the risk of death in patients with heart disease.


Stroke and Race and Ethnicity

Stroke is among the five leading causes of death for people of all races and ethnicities. But the risk of having a stroke varies. Compared to whites, African Americans are at nearly twice the risk of having a first stroke. Hispanic Americans’ risk falls between the two. Moreover, African Americans and Hispanics are more likely to die following a stroke than are whites.


Stroke and Geography

The country’s highest death rates due to stroke are in the 10) ___ United States.


Americans at Risk

Approximately 49% of adults have at least one major risk factor for heart disease and stroke.


High blood pressure, high LDL cholesterol, and smoking are key risk factors for heart disease. About half of Americans (49%) have at least one of these three risk factors.


Several other medical conditions and lifestyle choices can also put people at a higher risk for heart disease, including:


Risk Factors Percentage
Inactivity 39.5%
Obesity 33.9%
High Blood Pressure 30.5%
Cigarette Smoking 20.8%
High Cholesterol 15.6%
Diabetes 10.1%
Stress UNK



Exercise 20-30 minutes each day. Control your blood pressure and diabetes. Take one baby aspirin a day, and get 8 hours of sleep each night.


Eat a Dean Ornish MD, diet or adaptation of his recommendations, stay fit longer and reduce your chances of developing heart disease.


Source: HHS –



ANSWERS: 1) older; 2) stroke; 3) Heart; 4) earlier; 5) attack; 6) incomes; 7) food; 8) risk; 9) population; 10) southeastern


Dean Michael Ornish MD (1953 to present)



He chaired the Google Health Advisory Council from 2007 through 2009.



Dean Michael Ornish (born July 16, 1953) is a physician and president and founder of the nonprofit Preventive Medicine Research Institute in Sausalito, California, as well as Clinical Professor of Medicine at the University of California, San Francisco. Dr. Ornish is a native of Dallas, Texas, and holds a Bachelor of Arts summa cum laude in Humanities from the University of Texas at Austin. He earned his M.D. from the Baylor College of Medicine, was a Clinical Fellow in Medicine at Harvard Medical School, and served a medical internship and residency at Massachusetts General Hospital (1981-1984).


Dr. Ornish is known for his lifestyle-driven approach to the control of coronary artery disease (CAD) and other chronic diseases. Beginning in 1977, he directed a series of clinical research studies proving for the first time that comprehensive lifestyle changes could not only stop the progression of CAD but could actually reverse it. These lifestyle changes included a whole foods, plant-based diet, smoking cessation, moderate exercise, stress management techniques including yoga and meditation, and psychosocial support. He has acknowledged his debt to Swami Satchidananda for helping him develop this holistic perspective on preventive health.**



Swami Satchidananda, life-long vegetarian, teacher/preacher, yoga expert and more.



This result was demonstrated in a randomized controlled trial, known as the Lifestyle Heart Trial, in patients with pre-existing coronary artery disease. One-year data were published in the Lancet in 1990, and five-year data published in the Journal of the American Medical Association. Not only did patients assigned to the Ornish regimen fare better with respect to cardiac events than those who followed standard medical advice, their coronary atherosclerosis was somewhat reversed, as evidenced by decreased stenosis (narrowing) of the coronary arteries after one year of treatment. Most patients in the control group, by contrast, had narrower coronary arteries at the end of the trial than the start.


This landmark discovery was notable because it had seemed physiologically implausible, and it suggested cheaper and safer therapies against cardiovascular disease than invasive procedures such as coronary artery bypass surgery, angioplasty, and stents.



Ornish also directed the first randomized controlled trial demonstrating that comprehensive lifestyle changes may slow, stop, or even reverse the progression of early-state prostate cancer. This study was done in collaboration with the Chairs of Urology at the time at UCSF (Peter Carroll) and Memorial Sloan-Kettering Cancer Center (William Fair). Ornish’s program, which is now covered by Medicare for the treatment of heart disease, advocates a whole-foods, low-fat, largely vegetarian diet, regular exercise and stress reduction, as well as increased social support from family and friends.



In 2008, Ornish published research in collaboration with Elizabeth Blackburn showing that comprehensive lifestyle changes affect gene expression in only three months, turning on disease-preventing genes and turning off genes that promote cancer and heart disease and increasing telomerase enzyme that lengthens telomeres, the ends of chromosomes which control aging. Ornish is the author of six best-selling books, including Dr. Dean Ornish’s Program for Reversing Heart Disease; Eat More, Weigh Less; Love & Survival and his most recent book The Spectrum.


In 2010, after the former President’s cardiac bypass grafts became clogged, Ornish met with him and encouraged him to follow a mostly plant-based diet, because moderate changes in diet were not sufficient to stop the progression of his heart disease. Ornish recommends the consumption of fish oil supplements and does not follow a strict vegetarian diet, allowing for the consumption of occasional animal products.


Mostly, the Ornish diet gets kudos from the medical community for his highly restricted diet and healthy lifestyle routine. His documented studies showing a reversal of coronary blockage are indeed impressive. Neal Barnard, MD, president of the Physicians Committee for Responsible Medicine, says: “His diet is one of the only popular diet plans that is firmly rooted in science. It not only brings weight loss without counting calories, but it also brings good overall health. It reverses heart disease, cuts the risk of cancer, makes diabetes and hypertension more manageable, and sometimes even makes them go away.” The drawback is that the plan requires learning completely new eating habits, which many consider drastic. On the other hand, Robert H. Eckel, MD, former chair of the nutrition committee of the American Heart Association and a professor at the University of Colorado Health Sciences Center, is doubtful. He suggests that only the most committed will stick to Ornish’s routine: “Because it is so rigid and doesn’t allow a lot of food choices for those used to the Western diet, not many people will stay on it for the long term. Many people get tired of eating food with such a low fat content.”


Vegetarians, or those willing to become so for the long term, may be the only dieters who will find success with this plan. The recommendation to eat smaller, more frequent meals requires that dieters change their eating schedules, which could be difficult for some. Other than that, this plan has what it takes to lose weight and keep it off, and receives high marks from nutrition experts.


The Ornish diet was rated #1 for heart health by U.S. News & World Report in 2011 and 2012 and you can view Dean Ornish MD, presenting at TED and for more information click on: and


Sources:; (Sept 2013)


**Editor’s Note: Joyce Hays, THI CEO and co-founder and co-editor of ON TARGET, knew and studied with Swami Satchidananda; and in fact, had him as a houseguest one summer, in the Adirondack Mountains, where she and others taught him to sail. There he stood, wind-whipped saffron robes flying, against blue skies, as he manned the sails contentment exuding. He gave lectures to all the invitation-only summer residents, with cocktails and veggie juice and healthy snacks, afterwards, at the Hays compound, where he was staying. Swamiji, as he was called by those who knew him, loved to tool around in her Mercedes diesel (manual stick shift), with left leg folded in the half-lotus position. He was a wonderful friend, never to be forgotten.


Filed Under News | Leave a Comment

Effect of Comprehensive Lifestyle Changes on Telomerase Activity and Telomere Length in Men with Biopsy-Proven Low-Risk Prostate Cancer


Telomere shortness in human beings is a prognostic marker of ageing, disease, and premature morbidity. The previously found an association between 3 months of comprehensive lifestyle changes and increased telomerase activity in human immune-system cells. This follow-up study, published online in The Lancet Oncology (17 September 2013) compared ten men and 25 external controls who had biopsy-proven low-risk prostate cancer and had chosen to undergo active surveillance. Eligible participants were enrolled between 2003 and 2007 from previous studies and selected according to the same criteria. Men in the intervention group followed a program of comprehensive lifestyle changes (diet, activity, stress management, and social support), and the men in the control group underwent active surveillance alone. The relative telomere length and telomerase enzymatic activity per viable cell were compared at baseline and at 5 years, and assessed for any relationship to the degree of lifestyle changes.


Results showed that relative telomere length increased from baseline by a median of 0.06 telomere to single-copy gene ratio (T/S)units (IQR -0.05 to 0.11) in the lifestyle intervention group, but decreased in the control group (-0.03 T/S units, -0.05 to 0.03, difference p=0.03). When data from the two groups were combined, adherence to lifestyle changes was significantly associated with relative telomere length after adjustment for age and the length of follow-up (for each percentage point increase in lifestyle adherence score, T/S units increased by 0.07, 95% CI 0.02-0.12, p=0.005).


At 5 years, telomerase activity had decreased from baseline by 0.25 (-2.25 to 2.23) units in the lifestyle intervention group, and by 1.08 (-3.25 to 1.86) units in the control group (p=0.64), and was not associated with adherence to lifestyle changes (relative risk 0.93; p=0.57).


According to the authors, the comprehensive lifestyle intervention was associated with increases in relative telomere length after 5 years of follow-up, compared with controls, in this small pilot study, and that larger randomized controlled trials are warranted to confirm this finding.

Preclinical Alzheimer’s Disease and its Outcome: a Longitudinal Cohort Study


According to an article published in The Lancet Neurology (2013;12:957 – 965, new research criteria are being proposed for preclinical Alzheimer’s disease (AD), which include stages for:


1. cognitively normal individuals with abnormal amyloid markers (stage 1)
2. abnormal amyloid and neuronal injury markers (stage 2),
3. abnormal amyloid and neuronal injury markers and subtle cognitive changes (stage 3).


The goal of the study was to investigate the prevalence and long-term outcome of preclinical AD according to these criteria.


Study participants were cognitively normal (clinical dementia rating [CDR]=0) community-dwelling volunteers aged at least 65 years who were enrolled between 1998 and 2011 at the Washington University School of Medicine (MO, USA). CSF amyloid-beta1-42 and tau concentrations and a memory composite score were used to classify participants as normal (both markers normal), preclinical AD stage 1-3, or suspected non-AD pathophysiology (SNAP, abnormal injury marker without abnormal amyloid marker). The primary outcome was the proportion of participants in each preclinical AD stage. Secondary outcomes included progression to CDR at least 0.5, symptomatic AD (score of at least 0.5 for memory and at least one other domain and cognitive impairments deemed to be due to AD), and mortality. Survival analyses was performed using sub-distribution and standard Cox hazards models and linear mixed models.


Results showed that of the 311 participants, 129 (41%) were classed as normal, 47 (15%) as stage 1, 36 (12%) as stage 2, 13 (4%) as stage 3, 72 (23%) as SNAP, and 14 (5%) remained unclassified. The 5-year progression rate to CDR at least 0.5, symptomatic AD was 2% for participants classed as normal, 11% for stage 1, 26% for stage 2, 56% for stage 3, and 5% for SNAP. Compared with individuals classed as normal, participants with preclinical AD had an increased risk of death after adjusting for covariates (hazard ratio 6.2; p=0.040).


According to the authors, preclinical AD is common in cognitively normal elderly people and is associated with future cognitive decline and mortality. Thus, preclinical AD could be an important target for therapeutic intervention.

TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area



FDA Issues:

Final eSource Guidance


We are very pleased that the THI eSource solution full complies with the letter and spirit of the Guidance.


FDA has issued the final eSource Guidance which is very well written, very clear and good for the Industry. While FDA defines “should” as not a “must”, all of the “shoulds” seem quite reasonable.


The following are some of the highlights and changes from the original draft.


1)  Under II Background, FDA expanded the reasons for capturing source data electronically to remote monitoring:
a)  Eliminate unnecessary duplication of data
b)  Reduce the possibility for transcription errors
c)  Encourage entering source data during a subject’s visit, where appropriate
d)  Eliminate transcription of source data prior to entry into an eCRF
e)  Facilitate remote monitoring of data
f)  Promote real-time access for data review
g)  Facilitate the collection of accurate and complete data

2)  Under III.A.3, Data Element Identifiers, FDA clarified that:
a)  the audit trail begins, which is when the data is transmitted to the eCRF. This clarifies that we do not need to keep track of changes made by the investigator before transmission (e.g. changing values in the browser before submitting the data).

3)  Under III.A.4, Modifications and Corrections, it clearly states that:
a)  only the investigator or delegated study staff should perform modifications or corrections to eCRF data. This confirms that there is no such thing as “Self-Evident Corrections” which we never thought was a good idea.

4)  Under III.C. Retention of Records by Clinical Investigators:
a)  this new first paragraph seems to be the same, in principle, as the requirement for a “contemporaneous investigator copy” that the EMA supports. Looks like this is now a requirement of both FDA and EMA.
i)  “The clinical investigator(s) should retain control of the records (i.e., completed and signed eCRF or certified copy of the eCRF). The clinical investigator(s) should provide FDA inspectors with access to the records that serve as the electronic source data.

Peach Bread Pudding



This is a recipe by Dean M. Ornish MD, that I tried out this week. The photo is mine, not his. It’s quick and easy to make. I chose to try this recipe of his, because although peaches were glorious this summer season (never more sweet and juicy), they have now passed their peak. I had 8 of them left which had peaked, and didn’t want to waste them. This peach bread pudding worked out well.


Oh-h, and I didn’t have any stale bread lying around, so I went to my local market and asked for sour dough bread that was a few days old and got it at a discounted price. Don’t mind me, even if I were a gazillionaire, I would still like bargains.


You’ll like this recipe, if you don’t mind that the sweet component, is more or less missing. For those who don’t need a complete sugar/calorie restriction, I would do the following: just before serving, right after you take the peach bread pudding out of the oven, sprinkle more of the Amaretto liqueur (or rum or peach brandy) over the whole dish, according to your taste for this delicious addition. Then after cutting each individual serving, add a generous dollop of fat-free cool whip on top, with a tiny pinch of cinnamon. This dish is versatile. You can serve it for breakfast (warm or cold) with coffee or tea; wonderful for brunch, or a snack; and, of course, for a dessert.


By the way, this recipe smells wonderful while baking and fills your whole house up with peachy, bread-y fragrance. Serve it with coffee, tea, white wine, dessert wine, or more of the Amaretto.




  • 6 medium peaches
  • 2 cups skim milk
  • Pinch salt
  • 1 pound loaf of stale sourdough bread
  • 1 teaspoon Amaretto liqueur
  • 1/4 teaspoon freshly grated nutmeg
  • 1/2 cup apple juice concentrate
  • Juice of 1/2 lemon
  • 6 egg whites, beaten




1. Blanch, peel, pit, and then dice the peaches. Set aside.

2. In a large bowl, mix together the skim milk and salt. Tear the bread into 1-inch cubes. Mash the bread into the milk and let soak for 15 minutes.

3. While soaking, use another bowl to combine the Amaretto, nutmeg, apple juice concentrate, lemon juice, and peaches.

4. Add the beaten egg whites.

5. Add to the bread mixture and toss gently.

6. Pour into a nonstick 8- or 9-inch square pan, or a non-stick oven-proof pie dish.

7. Bake in a preheated oven at 350°F. for 45 minutes, or until set and browned on top.


My addition is to serve warm with a dollop of no-fat cool whip on top. Plus, according to your taste, after removing from oven, add extra Amaretto, or rum or your favorite liqueur, before adding the cool whip.



Coffee & Tea                                                 Amaretto or your favorite liqueur



A new analysis from the rover Curiosity found just one-sixth as much methane as previous studies. Methane gas can be a sign of microbial life, so this is disappointing news.
By Francie Diep



Mount Sharp NASA/JPL-Caltech/MSSS


Hold your horses (cows?), guys. A new analysis of data from the Curiosity rover found there’s very little methane in the atmosphere of Mars. Methane gas can be a sign of biological activity—of microbial Martians, farting up the atmosphere—so we’re feeling a bit disappointed.

At most, the Martian atmosphere has a methane concentration of 1.3 parts per billion, according to the new analysis. That’s one-sixth as much as previous estimates. The measurement means there’s little chance methane-producing organisms are currently living on Mars, the researchers wrote in a paper they published today in the journal Science.

The data came from Curiosity’s Tunable Laser Spectrometer, which was specially designed to look for methane gas. The instrument has not detected any methane to date. (The team last gave us a similarly sad update on Curiosity’s findings in late 2012).

Previous studies of methane on Mars, conducted using data from telescopes based on Earth and in orbit around the red planet, have found more of the gas. Some analyses have found different concentrations of methane at different sites on the planet, or at different times of year. In 2003, one team reported seeing strong plumes of methane at a different location than where Curiosity sampled. That 2003 study has been controversial among astronomers.

There are micro-organisms that don’t produce methane, so we’re not totally giving up on the possibility of Martians just yet.

Nor does the presence of methane mean there definitely is, or was, something living on a planet. If the Mars air does contain methane, it could come from living organisms, extinct organisms, or geological (not biological) processes within the planet itself. It could have also been carried there from elsewhere in space.



A new study says people act more selfishly when dealing with wide-faced men.
By Shaunacy Ferro



Wide Face Courtesy UC Riverside
Golden Rule: If you’re mean to people, they’ll be mean back.


Man, it’s a tough time to be a big-faced dude. Last year, two management professors at the University of California, Riverside found that men with wider faces were more likely to cheat and lie for financial gain. Now, their latest study finds that the selfishness of wide-faced men is a self-fulfilling social prophesy: People perceive men with wider faces as more aggressive and less trustworthy, so they act more selfishly toward them, eliciting selfish behavior in return, the researchers say.

The study consisted of multiple experiments with more than 100 participants in each. First, the researchers found men with wider faces were more likely to be selfish when allocating resources between them and a partner. In another study, participants were shown a picture of their partner in this same resource-allocation task–some saw a digitally manipulated picture of a man with a comparatively wide face, while others saw the same man with a more narrow face. People who saw the wide-faced man as their partner anticipated selfish behavior, and were selfish in how they divided the resources. People who thought they were working with a narrow-faced man behaved more cooperatively.

In yet another experiment, the researchers informed participants of how their unseen, simulated partner had chosen to divide resources before they had to make an allocation decision themselves. How the “partner” treated the participant was based on results from two of the previous experiments the researchers had conducted–either the participants were treated as if they were a wide-faced man (whom people perceived as selfish) or as a more narrow-faced man (whom people treated with cooperation). The researchers found that treating someone selfishly led them, in turn, to act more selfish.

As the paper puts it:

Our results suggest that men with greater [facial width-to-height ratios] experience less cooperation and more competition from others compared to men with smaller [facial width-to-height ratios], and these differences in exposure to social interactions may also affect men’s general predisposition to cooperate or compete.

The underlying causes of this correlation are debatable, of course. Studies have shown that having a wide face is associated with greater aggression, which might influence how people behave. Or people may perceive big men with wide faces as physically strong, so there might be some factors of dominance involved. And the study didn’t control for the participants’ facial width, so there’s no way to know if their own facial traits affected the results.

Still, this seems to be just a scientific validation of the Golden Rule: If you’re mean to people, they’ll be mean back. And don’t judge a book by its super-wide face.

The full study is available in PLOS ONE.



← Previous PageNext Page →