Hurricane Sandy

 

All of us at Target Health want to thank the outpouring of concern from our friends and colleagues from all over the world, even as far away as Australia.

 

This has been a very tough week in the New York City metropolitan area as well as the surrounding metropolitan areas where many of our staff live.  As there has been mass devastation and loss of life, the city will take time to recover and heal. Many of our staff lost power and unfortunately, some homes were damaged by falling trees. But, as always, like after 911, we will persevere.

 

We should all be back to our offices Monday as power and public transportation are coming back to life. There was no interruption of our global EDC operations and document management services as our commercial software servers are all housed in secure environments with full redundancy.

 

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 at www.targethealth.com

Turmeric (Curcuma domestica Valet)

 

Vanessa Hays JD, is the inspiration and contributor of all the information on the health importance of Turmeric, used in this issue of ON TARGET, in the Quiz section, the History of Medicine section and the Healthy Eating section.

 

Adding a dash of curry powder with turmeric to what you eat may help keep your brain healthy for life

 

 

Turmeric is a very important spice in Asia, which produces almost all of the world’s crop and uses 80% of it. Turmeric usage dates back nearly 5000 years, to the Vedic culture in 1) ___, when turmeric was the principal spice and also of religious significance. Use of turmeric for both culinary and medical purposes began to spread in the following centuries, first reaching China and the Middle East.

 

In India, turmeric is still added to nearly every dish, be it meat or vegetables. India’s Ayurvedic 2) ___ tradition dating from the seventh century BCE, lists turmeric as an ingredient in external preparations for wounds and hemorrhoids and in internal medicines for treating jaundice and improving memory. Clay tablets from Mesopotamia inscribed around 650 BCE during the rule of Assyrian King Ashurbanipal describe turmeric as a brewing spice, stomach tonic and dye plant. An ointment was made out of turmeric to relieve the effects of poisoned food.

 

Turmeric has been used medicinally throughout Asia to treat stomach and liver ailments. It also was used externally, to heal sores, and as a cosmetic. Chinese writings from the 7th and 8th centuries CE mention turmeric use for medicine, cooking and making yellow dye. During his travels in China in 1280, 3) _____ ____ encountered a widely used, saffron-colored food seasoning that was most likely turmeric or a closely related species. In Medieval Europe, turmeric did not prove as popular a spice as ginger and other Eastern imports but was valued more as a food colorant and textile dye. It was also used as a remedy for menstrual and digestive problems, ulcers, gallstones, inflammation and cancer-like diseases.

 

In 1815 chemists Vogel and Pelletier isolated and gave a name to curcumin, an orange-yellow extract of turmeric. Today, researchers are investigating the effectiveness of 4) ___–turmeric’s most biologically active component –in treating Alzheimer’s disease, cancer, inflammatory diseases and many other conditions.

Turmeric is part of all 5) ___ powders, and is found in the cuisine of Ethiopia, other African countries as well as islands in the Caribbean. In South East Asia, the fresh spice is much preferred to the dried. In Thailand, the fresh rhizome is grated and added to curry dishes; it is also part of the yellow curry paste.

 

Turmeric comes from the root of Curcuma longa, a leafy plant in the ginger family. The root, or rhizome, has a tough brown skin and bright orange flesh. The spice is also sometimes called ‘Indian saffron’ thanks to its brilliant yellow color, but should not be confused with saffron, which has a completely different taste and smell.

 

Turmeric, the spice used for thousands of years, may be a powerful new weapon in fighting Alzheimer’s Disease, researchers are now saying. Researchers from UCLA and the Department of Veterans Affairs said their study of curcumin, the yellow compound from turmeric, found it broke up existing beta amyloid on rats’ 6) ___ and helped prevent accumulation of the destructive plaque. Reporting, recently, in the Journal of Biological Chemistry, the team said curcumin is more effective in stopping the protein fragments from forming, than many other drugs being tested to treat the disease that affects 4 million Americans and millions more worldwide. “The prospect of finding a safe and effective new approach to both prevention and treatment of Alzheimer’s disease is tremendously exciting,” said Gregory Cole PhD, the main UCLA investigator. “Curcumin has been used for thousands of years as a safe anti-inflammatory in a variety of ailments as part of Indian traditional medicine,” Cole said. Recent animal studies “support a growing interest in its possible use for diseases of aging involving oxidative damage and inflammation like Alzheimer’s, cancer and 7) ___ disease.”

 

Cole called for human trials of curcumin to establish safe and effective 8) ___. Curcumin inhibits formation of amyloid beta oligomers and fibrils and binds plaques and reduces amyloid in vivo.

 

ANSWERS: 1) India; 2) medical; 3) Marco Polo; 4) curcumin; 5) curry; 6) brains; 7) heart; 8) doses

Gregory M. Cole PhD &Turmeric/Curcumin

 

 

Why, according to the WHO, does India have among the lowest rate of AD in the industrialized world? It is their historic use of curry?

 

The current consensus is that there are probably two causes of AD. One cause is an increased production and accumulation of a protein called amyloid-beta 42 around brain cells. The other cause is accumulation of a different protein called tau tangles in brain cells. Both causes trigger inflammation, which is the direct cause of these brain cells dying. Studies on mice seemed to show that curcumin, the compound derived from turmeric, actually reversed a cause of the disease.

Dr. Gregory M. Cole is currently a Professor of Medicine and Neurology at UCLA where he is also the Associate Director of the UCLA Alzheimer’s Center and Associate Director for Research at the Geriatric Research, Education and Clinical Center for the Greater Los Angeles Veterans Administration System.

 

After receiving undergraduate degrees in Physics and Biochemistry from University of California at Berkeley and working in an immunology lab at Harvard Medical School, he returned to Berkeley for doctoral work on Alzheimer’s and aging (under Professor emeritus Paola Timiras) and then moved to San Diego for postdoctoral work on Alzheimer’s at UCSD.

 

His work over the last two decades has been centered on the production and role of beta amyloid in Alzheimer’s disease (AD). Based in part on a series of screens in pre-clinical models, three compounds, R-flurbiprofen, curcumin and DHA are already in or under serious consideration for clinical trials. Dr. Cole’s research is exploring the potential for AD prevention with omega 3 fatty acid (DHA, docosahexaenoic acid from fish) and the curry spice extract, curcumin, to control inflammation and oxidative damage. His laboratory is also exploring the role of omega 3 and other dietary fatty acids control the neuroprotective PI3-kinase>Akt pathway, synaptic protein loss, amyloid and cognitive deficits. Other recent contributions include the co-development of amyloid and tangle PET imaging probes.

 

Dr. Cole has shown in both in vitro and in vivo experiments that curcumin fights the amyloid that accumulates in the brain in AD by: (1) breaking down accumulation of amyloid-beta plaques, (2) preventing amyloid from forming in the first place, and (3) helping reduce how much cholesterol is available in the brain. (High cholesterol levels have been linked to an increased risk of AD.

 

The rationale as to why curcumin helps can be found in two academic articles, “Neuroprotective Effects of Curcumin” (Advances in Experimental Medicine and Biology, 2007) and “A Potential Role of the Curry Spice Curcumin in Alzheimer’s Disease” (Current Alzheimer Research, 2005). Dr. Gary Small, also at UCLA, has co-written a popular book titled “The Alzheimer’s Prevention Program: Keep Your Brain Healthy for the Rest of Your Life” which puts a spotlight on turmeric. According to Dr. Small, “People who eat food spiced with turmeric/curcumin frequently do better on memory tests.” If true, this is pretty amazing.

 

A clinical trial studying whether curcumin can prevent the build-up of amyloid in the brain started in March 2012 and will continue for four years. So what are we to do until those results come out? Eat turmeric/curcumin and more spices like black peppers which may have a synergistic ability to help our bodies get more out of the spices we eat. Also, when cooking at home, add a dash of turmeric/curry powder to whatever dish you’re making, to keep your brain healthy for a long, long time.

ONCOLOGY

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Aspirin Use, Tumor PIK3CA Mutation, and Colorectal-Cancer Survival

 

Regular use of aspirin after a diagnosis of colon cancer has been associated with a superior clinical outcome. Experimental evidence suggests that inhibition of prostaglandin-endoperoxide synthase 2 (PTGS2) (also known as cyclooxygenase-2) by aspirin down-regulates phosphatidylinositol 3-kinase (PI3K) signaling activity. As a result, a study published in the New England Journal of Medicine (2012; 367:1596-1606), evaluated whether the effect of aspirin on survival and prognosis in patients with cancers characterized by mutated PIK3CA (the phosphatidylinositol-4,5-bisphosphonate 3-kinase, catalytic subunit alpha polypeptide gene), might differ from the effect among those with wild-type PIK3CA cancers.

 

For the study, survival data were obtained from 964 patients with rectal or colon cancer from the Nurses’ Health Study and the Health Professionals Follow-up Study, including data on aspirin use after diagnosis and the presence or absence of PIK3CA mutation. In addition, the following tumor markers were evaluated: PTGS2, phosphorylated AKT, KRAS, BRAF, microsatellite instability, CpG island methylator phenotype, and methylation of long interspersed nucleotide element 1.

 

Results showed that among patients with mutated-PIK3CA colorectal cancers, regular use of aspirin after diagnosis was associated with superior colorectal cancer–specific survival (multivariate hazard ratio for cancer-related death (0.18; P<0.001) and overall survival for death from any cause (0.54; P=0.01). In contrast, among patients with wild-type PIK3CA, regular use of aspirin after diagnosis was not associated with colorectal cancer–specific survival (0.96; P=0.76) or overall survival (0.94; P=0.96).

 

According to the authors, regular use of aspirin after diagnosis was associated with longer survival among patients with mutated-PIK3CA colorectal cancer, but not among patients with wild-type PIK3CA cancer. The findings from this molecular pathological epidemiology study suggest that the PIK3CA mutation in colorectal cancer may serve as a predictive molecular biomarker for adjuvant aspirin therapy.

Does Low-Dose Acetylsalicylic Acid Prevent Cognitive Decline in Women With High Cardiovascular Risk?

 

According to an article published in BMJ Open Online (3 October 2012), a study was performed to examine whether low-dose acetylsalicylic acid (ASA) influences the rate of cognitive change in elderly women.

 

The investigation was a prospective, population-based cohort study. The sample was derived from the Prospective Population Study of Women and from the H70 Birth Cohort Study in Gothenburg, Sweden. Both samples were obtained from the Swedish Population Register, based on birth date, and included 789 (response rate 71%) women aged 70–92 years. After the exclusion of individuals with dementia and users of warfarin, clopidogrel or heparin at baseline, 681 women were examined. Among all participants, 95.4% (N=601) had a high cardiovascular risk (CVD), defined as 10% or higher 10-year risk of any CVD event according to the Framingham heart study and 129 used low-dose ASA (75–160mg daily) at baseline. After 5 years, a follow-up was completed by 489 women.

 

The main outcomes measures included cognitive decline and dementia incidence in relation to the use of low-dose ASA and cardiovascular risk factors. Cognition was measured using the Mini Mental State Examination (MMSE), word fluency, naming ability and memory word tests. Dementia was diagnosed according to the DSM-III-R criterion. A secondary outcome was incidence of stroke and peptic ulcer in relation to low-dose ASA use.

 

Results showed that women on regular low-dose ASA declined less on MMSE at follow-up than those not on ASA. This difference was even more pronounced in those who had ASA at both examinations (p=0.004 compared with never users; n=66 vs. n=338). All other cognitive tests showed the same trends. There were no differences between the groups regarding short-term risk for dementia (N=41).

 

According to the authors, low-dose ASA treatment may have a neuroprotective effect in elderly women at high cardiovascular risk.

Weight Loss Does Not Lower Heart Disease Risk From Type 2 Diabetes

 

Type 2 diabetes affects nearly 24 million people in the United States alone, and has increased in prevalence along with the country’s epidemic of overweight and obesity. Cardiovascular diseases are the most common cause of death among people with type 2 diabetes. According to a study supported by the National Institutes of Health, an intensive diet and exercise program resulting in weight loss does not reduce cardiovascular events such as heart attack and stroke in people with longstanding type 2 diabetes.

 

The Look AHEAD (Action for Health in Diabetes) study tested whether a lifestyle intervention resulting in weight loss would reduce rates of heart disease, stroke, and cardiovascular-related deaths in overweight and obese people with type 2 diabetes, a group at increased risk for these events.

 

Researchers at 16 centers across the United States worked with 5,145 people, with half randomly assigned to receive an intensive lifestyle intervention and the other half to a general program of diabetes support and education. Both groups received routine medical care from their own health care providers. Although the intervention did not reduce cardiovascular events, Look AHEAD has shown other important health benefits of the lifestyle intervention, including decreasing sleep apnea, reducing the need for diabetes medications, helping to maintain physical mobility, and improving quality of life. Previous Look AHEAD findings are available.

 

Data are currently being analyzed to fully understand the cardiovascular disease results and a report of the findings are being prepared for a peer-reviewed publication.

 

According to the authors, few, if any, studies of this size and duration have had comparable success in achieving and maintaining weight loss. Participants in the intervention group lost an average of more than 8% of their initial body weight after one year of intervention, and maintained an average weight loss of nearly 5% at four years, an amount of weight loss that experts recommend to improve health. Participants in the diabetes support and education group lost about 1% of their initial weight after one and four years.

 

In September 2012, the NIH stopped the intervention arm, acting on the recommendation of the study’s data and safety monitoring board. The independent advisory board, charged with monitoring the study data and safety of participants, found that the intensive lifestyle did no harm but did not decrease occurrence of cardiovascular events, the primary study goal. At the time, participants had been in the intervention for up to 11 years.

 

Because there was little chance of finding a difference in cardiovascular events between the groups with further intervention, the board recommended stopping the intensive lifestyle intervention, but encouraged the study to continue following all Look AHEAD participants to identify longer-term effects of the intervention.

 

While the intervention group did not have fewer cardiovascular events than the group receiving general diabetes support and education, one positive factor was that both groups had a low number of cardiovascular events compared with previous studies of people with diabetes.

 

Look AHEAD is the first study to examine the long-term effects of a lifestyle intervention on major cardiovascular disease events and death in adults with type 2 diabetes.

 

“Look AHEAD provides important, definitive information about the long-term health effects of weight loss in people with type 2 diabetes,” said NIDDK Director Dr. Griffin P. Rodgers. “Beyond cardiovascular disease, this study and others have shown many other health benefits of weight loss through improved diet and increased physical activity. For example, for overweight and obese adults at high risk for diabetes, modest weight loss has been shown to prevent or delay developing type 2 diabetes.”

 

Participants were 45 to 76 years old when they enrolled in the study. Sixty percent of enrollees were women. More than 37% were from racial and ethnic minority groups. Researchers are now analyzing data to measure effects of the lifestyle intervention on subgroups, including racial and ethnic groups and people with a history of cardiovascular disease.

 

Find more information about the Look AHEAD trial, including a list of current publications, at <www.lookaheadtrial.org>. For a list of centers enrolling patients for diabetes or obesity trials, search for keywords “diabetes” or “obesity” at <www.clinicaltrials.gov>.

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

 

 

CDRH Entrepreneurs-in-Residence (EIR)

 

 

FDA’s Center for Devices and Radiological Health is participating in a pilot agency program sponsored by the White House Office of Science and Technology Policy that brings innovation experts into federal agencies to collaborate on improving business models that will empower positive change, including economic growth, job creation, and leadership in innovation technology. The EIR program allows CDRH to engage with more than a dozen outside experts who bring state-of-the art thinking in business process and medical device innovation, decision science, and information technology. Five of these entrepreneurial experts will work alongside staff and management to build an early working version of the Innovation Pathway program, a priority premarket review program whose principal focus is on technologies that demonstrate the potential to revolutionize disease treatment, diagnosis, or health care delivery and that target unmet medical needs.

 

The ability to effectively identify, anticipate, and respond to technological innovation and scientific breakthroughs is particularly challenging in the medical device realm because of the tendency of these devices to emerge and evolve rapidly. To increase FDA’s preparedness in this area, CDRH will identify emerging trends in science and technology by enhancing its current horizon scanning methodology, an approach that incorporates information from a broad range of sources, such as reviewing important scientific literature and accounting for public health needs, seeking input from manufacturers and other stakeholders, and considering technologies funded by other government agencies. In addition, CDRH, in an effort to enhance its scientific capabilities, is in the process of developing a Network of Experts to serve as a resource to address scientific questions and provide better understanding of emerging technologies in fields where FDA reviewers may not be immediately familiar.

Cauliflower Baked with Turmeric and Ginger

 

 

Ingredients

 

  • 3 tablespoons Canola or Olive oil
  • 1 tablespoon black mustard seeds
  • 1 jalapeno, finely diced (optional) this is too hot for us
  • 1 tablespoon grated fresh ginger
  • 1 teaspoon turmeric
  • 1 head cauliflower, cut into florets
  • Salt (optional)
  • One grind of black pepper (optional)

 

Directions

 

  • Preheat oven to 425 degrees F.
  • Wash the cauliflower and dry it with paper towels. Then break it up into florets. You don’t have to use the stalks unless you want to. If you do, just dice them and use along with the florets.
  • In a small bowl, whisk together the oil, mustard seeds, (optional jalapeno), ginger, and turmeric (salt & pepper, if you wish) in a small bowl.
  • Place cauliflower florets in a medium baking dish. Pour the oil mixture over the cauliflower and toss until all of the florets are well covered . Roast until lightly golden brown and just tender, 20 to 25 minutes. Serve hot.

 

Variation: simply add some toasted pine nuts or cashews ten minutes before the cauliflower is done.

 

This delicious dish is good at brunch lunch or dinner, served with fish or poultry and with a nicely chilled white wine and your favorite warm bread. Enjoy!

 

 

Cheers!

Healthy Turmeric Tea

 

 

A spicy dish of Indian biryani and a hot dog purchased at the ball game may seem to have little in common, but both feature a liberal quantity of turmeric (Curcuma longa). In the biryani, the spice is an essential part of the curry mixture that gives the dish its distinctive zing. In the hotdog, turmeric is what makes the slathering of American mustard bright yellow.

 

The good news about this cross-cultural spice is that elderly villagers in India, who eat turmeric in their daily curries, have the world’s lowest rate of Alzheimer’s disease. That does not appear to be a coincidence. In a study at the University of California at Los Angeles, scientists fed curcumin, an active compound in turmeric tea, to rats prone to accumulate beta-amyloid plaque in their brains – the abnormality associated with Alzheimer’s disease in humans. Curcumin blocked the plaque’s accumulation. It also appeared to reduce inflammation related to Alzheimer’s disease in neural tissue. The rats fed curcumin also performed better on memory tests than rats on normal diets.

 

Other studies have suggested turmeric has broad anti-inflammatory and anti-cancer effects as well. But few Americans eat enough curry to achieve these protective effects. Although Dr. Andrew Weil does not recommend daily mustard-laden hot dogs as the ideal turmeric delivery device, he found a potential solution during one of his many trips to Okinawa, the island nation with the world’s longest average life span, 81.2 years.

 

Okinawans drink copious quantities of turmeric tea. Some brew it fresh, but others simply buy cans or powdered instant versions of unsweetened tea from their local stores.

 

If you would like to try it, here’s a recipe. Feel free to experiment with the ingredients and flavorings until you find a combination that suits your taste:

 

  • Bring four cups of water to a boil.
  • Add one teaspoon of ground turmeric and reduce to a simmer for 10 minutes.
  • Strain the tea through a fine sieve into a cup, add honey and/or lemon to taste.

 

Some people like to add a teaspoon of ginger along with the turmeric. While ground versions are more convenient, it’s worthwhile to experiment with freshly grated turmeric for a more vibrant flavor. These distinctive, deep-orange roots are increasingly available in American grocery and natural food stores. One of the most comprehensive summaries of turmeric studies is published by ethnobotanist James A. Duke, PhD. Here are some of the diseases that turmeric has been found to help prevent or alleviate:

 

  • Alzheimer’s disease: Duke found more than 50 studies on turmeric’s effects in addressing Alzheimer’s disease. The reports indicate that extracts of turmeric contain a number of natural agents that block the formation of beta-amyloid, the substance responsible for the plaques that slowly obstruct cerebral function in Alzheimer’s disease.
  • Arthritis: Turmeric contains more than two dozen anti-inflammatory compounds, including six different COX-2-inhibitors (the COX-2 enzyme promotes pain, swelling and inflammation; inhibitors selectively block that enzyme). By itself, writes Duke, curcumin – the component in turmeric most often cited for its healthful effects – is a multifaceted anti-inflammatory agent, and studies of the efficacy of curcumin have demonstrated positive changes in arthritic symptoms.
  • Cancer: Duke found more than 200 citations for turmeric and cancer and more than 700 for curcumin and cancer. He noted that in the handbook Phytochemicals: Mechanisms of Action, curcumin and/or turmeric were effective in animal models in prevention and/or treatment of colon cancer, mammary cancer, prostate cancer, murine hepatocarcinogenesis (liver cancer in rats), esophageal cancer, and oral cancer. Duke said that the effectiveness of the herb against these cancers compared favorably with that reported for pharmaceuticals.

 

Source: Andrew Weil MD, DrWeil.com, by Brad Lemley

 

Turmeric: When Food is Medicine

 

 

Adapted from WebMD.com, by Carolyn Brown, MS, RD

 

Turmeric might just be magical said Carolyn Brown after running in a 10k (6.2 mile) race that she hadn’t trained for properly — or trained much for at all. Normally, she says this results in insane soreness and complaints with every move for a couple of days. This all started when she went on a super anti-inflammatory kick taking Turmeric, the brightly hued and earthy flavored root as her new staple ingredient, finding its way into quinoa, smoothies and green juices, teas, and even chicken marinade recipes.

 

While Carolyn can’t promise turmeric will be the magic cure for all your aches and pains, she says that it is definitely worth a shot. She claims that it’s anti-inflammatory and pain-reducing effects are comparable to potent drugs like hydrocortisone and OTC meds. Evidence suggests that turmeric and the active agent in it, curcumin, has incredible anti-inflammatory and disease preventative benefits.

 

Carolyn says that the researchers explain it best, so she’ll let them do the talking: “Curcumin has been shown to exhibit antioxidant, anti-inflammatory, antiviral, antibacterial, antifungal, and anticancer activities and thus has a potential against various malignant diseases, diabetes, allergies, arthritis, Alzheimer’s disease, and other chronic illnesses” (Advanced Experimental Medical Biology). Other specific chronic illnesses turmeric may be preventative or therapeutic for: IBD, cirrhosis, and heart disease.

 

So how do you get turmeric into your daily life? Well you may already be eating it: It’s responsible for the bright yellow color of mustard and curry powders. But for those who don’t eat curry every day, there are other ways to work it into your diet. A company called Turmeric Elixir of Life is bottling the stuff in a sweet/spicy drink form. Tons of teas contain it (Organic Turmeric Snap from David’s Tea). But it’s far cheaper and just as easy to buy the root at the grocery store – you’ll probably find it next to its relative, ginger, in the produce section – and that way you can add it to just about anything you like. For optimum curcumin concentration you can also get it in supplement form.

 

 

Reflections From Mehmet Oz MD: When Food is Medicine

 

  • Did you know your spice rack is full of anti-aging secrets? Research shows that cinnamon can decrease blood-sugar levels and lower cholesterol, especially in people with type 2 diabetes.
  • Arthritis sufferers may also find relief in turmeric, a spice found in curry that has also been reported to help prevent Alzheimer’s disease, he says.
  • Paprika and cayenne pepper can help fight high blood pressure and improve circulation, he says.
  • In lab studies, eating rosemary has been shown to improve learning rates in rats — data that has been reproduced in humans.
  • Even ginger can decrease blood pressure, alleviate arthritis pain, and reduce your risk of cancer. Although fresh spices are usually best, dried ones can still fight aging.