0 New Diabetes Drug Gets FDA Panel Backing

Last Friday, the day after the FDAs Endocrinologic & Metabolic Drugs Advisory Committee endorsed the inhaled insulin Exubera^TM, it gave its nod to another new diabetes drug, Pargluva^TM.

Unlike Exubera^TM, Pargluva^TM (also known as muraglitazar) is not an insulin, nor is it inhaled. It is a new oral medication developed by Bristol-Myers Squibb and Merck for the treatment of type 2 diabetes.

Pargluva^TM falls into the new class of diabetes drugs called glitizars. It is designed not only to lower blood glucose but to improve triglyceride and HDL (good cholesterol) levels as well.

The drug received endorsement in spite of:

1. Questions of conflict-of-interest among panel members. (See New York Times story below.)
   
   
2. Possible health risks. The non-profit group Public Citizen (see story below) is arguing against FDA approval of Pargluva based on risks, notably heart problems, uncovered during clinical trials.

Again, as with Exubera^TM, endorsement by an FDA panel does not assure final FDA approval. But this action brings the drug that much closer to marketability.

________
Bristol-Myers Squibb/Merck press release:
Bristol-Myers Squibb And Merck Joint Statement On FDA Advisory Committee Vote On Pargluva™ (Muraglitazar), An Investigational Oral Treatment For Type 2 Diabetes

New York Times story, Sept. 10:
Panel Backs Drug Amid Conflict Concerns

Public Citizens press release:
Testimony Before FDA Advisory Committee on New Diabetes Drug Muraglitazar (Pargluva): Risks Outweigh the Benefits

0 Veggie Might Top 5 Reasons I Love New York A Recipe

Written by the fabulous Leigh, Veggie Might is a weekly Thursday column about all things Vegetarian.

Today, my Fair Readers, is the 15th anniversary of the day my pal JBF dropped me, my two milk crates of books, and my dreams in front 201 W. 91st, New York, NY. Our journey originated in Orlando, took side trips to our respective familial homes in North Carolina and Virgina, and ended with JBF settling in Princeton, NJ and me in the Big City. Fifteen years, three apartments, and 17 roommates later, I’m still here and loving New York.

Top 5 Reasons I Love New York

1. Each neighborhood is like its own little city. Residents get to know their neighbors, the best places to buy groceries, which laudromat gives the most time per quarter, and the coffee shop with the most lenient WiFi/purchase policy. New Yorkers are as proud of and loyal to their neighborhoods as Europeans or South Americans are to their countries during the World Cup. HELL’S KITCHEN RULZ!!!1!!1!

2. Public transportation! Not only does the MTA get you from point A to point B (most of the time), it’s a world-class entertainment venue. Nowhere else can you learn cutting-edge modern dance moves, stay abreast of the hottest indie music, and have your picture made for $2.15 a pop.

3. Governors Island, the car-free, bike-loving island oasis in New York Harbor. Governors Island is dotted with art installations, criss-crossed by bike paths, and inviting for a picnic or just chilling.

4. The food, of course. In one afternoon, you can grab brunch at one of a million amazing restaurants, pick up your fresh produce at the farmers’ market, snag a homemade popsicle from a street vendor, and hit the Mexican/Korean/Indian/West African/Chinese grocery for the spices and miscellany needed to make a delicious home-cooked supper.

5. Dinner parties/potlucks/game nights in cramped apartments with brilliant friends and home-cooked food. No one who lives in New York on a work-a-day budget can afford to eat out all the time, so the best way to socialize and economize is to cook for each other. Juggling plates while 4-to-a-couch with a few folks on the floor is part of the charm. Karaoke is a bonus.

Happy anniversary, New York. I made you this mushroom quinotto.

~~~

If this post tips your canoe, swim on over to
Pumpkin Orzo with Sage
Butternut Squash Risotto
Swiss Chard with Mushrooms

~~~

Quinoa-Millet Mushroom Risotto (Quinotto)

adapted from Viva Vegan! by Terry Hope Romero
serves 4

Note: The recipe calls for white wine, but I used a substitution of apple juice and apple cider vinegar. I used a blend of quinoa and millet because I was low on the big Q; go all the way with one or the other and my blessing. I also tossed in a few beet greens, which go nicely with this dish, but I would advise against going overboard with the greens. The mushrooms should be the star.

1/2 lb crimini mushrooms
1 1/2 tbsp olive oil
3 shallots, minced
3 cloves garlic, minced
2/3 cup quinoa, rinsed in a mesh strainer
1/3 cup millet
1/2 cup apple juice + 1 tsp apple cider vinegar (or 1/2 white wine)
1/2 tsp dried thyme, crushed
1/2 tsp dried oregano
1 jalapeño pepper, finely chopped
3 cups hot vegetable broth or stock
1 cup beet greens, shredded (or any leafy green)
1 tbsp lime juice
salt and pepper to taste
fresh cilantro or parsley to garnish

Instructions
1. Brush or wipe dirt from mushrooms and slice into matchsticks. In a large saucepan, sautee mushrooms in half the olive oil over medium heat for about 5-7 minutes. Put mushrooms in a bowl and set aside.

2. In the same saucepan, heat the remaining oil and sautee shallots and garlic for 5-7 minutes or until onion is translucent. Add quinoa and millet to onion/garlic mixture. Cook for 2 minutes or until grains become golden.

3. Add apple juice + vinegar to deglaze the pan, and stir. Add dried spices and jalapeño and cook for another minute. Stir in mushrooms.

4. Here comes the real stirring: pour in about 1/4 of broth to grain/vegetables. Bring broth to a boil, then reduce heat to a simmer and, stirring frequently, allow grain to absorb the broth. Then add another fourth of the broth, stirring until the liquid is absorbed. Repeat this process until all the broth is absorbed and the grains are light and fluffy, about 30-35 minutes.

5. Salt and pepper to taste along the way. Cover and allow quinoa/millet to rest for 10 minutes. Drizzle with lime juice, toss in beet greens, and fluff with a fork. Serve with fresh cilantro. Your guests will be impressed that you made such a brilliant, flavorful, earthy dish in such a tiny kitchen.

Approximate Calories, Fat, Fiber, Protein, and Price per Serving
282 calories, 7.7g fat, 5.15g fiber, 7.6g protein, $1.31

Calculations
1/2 lb crimini mushrooms:: 64 calories, 0g fat, 0g fiber, 0g protein, $2.00
1 1/2 tbsp olive oil: 180 calories, 21g fat, 0g fiber, 0g protein, $0.12
3 shallots: 90 calories, 0g fat, 9g fiber, 6g protein, $0.60
2/3 cup quinoa: 417 calories, 6.7g fat, 8g fiber, 16g protein, $0.97
1/3 cup millet: 251.7 calories, 2.7g fat, 5.6g fiber, 7.3g protein, $0.28
1/2 cup apple juice + 1 tsp apple cider vinegar: 57 calories, 0g fat, 0g fiber, 0g protein, $0.41
1/2 tsp dried thyme: negligible calories, fat, fiber, protein, $.02
1/2 tsp dried oregano: negligible calories, fat, fiber, protein, $.02
1 jalapeño pepper: 4 calories, 0g fat, 0g fiber, 0g protein, $0.16
3 cups hot vegetable broth: 60 calories, 0.3g fat, 0g fiber, 0g protein, $0.57
1 cup beet greens: 8 calories, 0g fat, 1g fiber, 1g protein, $0.16
1 tbsp lime juice: 4.75 calories, 0g fat, 0g fiber, 0g protein, $0.05
salt and pepper to taste: negligible calories, fat, fiber, protein, $.02
fresh cilantro or parsley to garnish: negligible calories, fat, fiber, protein, $.02
TOTALS: 1128.5 calories, 30.7g fat, 20.6g fiber, 30.3g protein, $5.24
PER SERVING (totals/4): 282 calories, 7.7g fat, 5.15g fiber, 7.6g protein, $1.31

0 New YouTube Channel Cooking With Gram

Hi guys, just wanted to notify everyone of my new YouTube channel that I started today. Its called Cooking With Gram; the idea is that Ill be making recipes and showing some cooking tips with my adorable grandma. Eventually, Ill be doing other videos too, maybe some nutrition education videos, some practical healthy eating tips, etc. Anyway, check it out, like it on YouTube, and subscribe!!

0 New York Times 4 Part Series on Diabetes

Heres the entire series the New York Times ran last week. You may need to register for access, but its free.

• Diabetes and Its Awful Toll Quietly Emerge as a Crisis - January 9, 2006
  
• By the Numbers: One Scourge in 2 Forms - January 9, 2006
  
• Living at an Epicenter of Diabetes, Defiance and Despair - January 10, 2006
  
• In the Treatment of Diabetes, Success Often Does Not Pay - January 11, 2006
  
• East Meets West, Adding Pounds and Peril - January 12, 2006

Click here to view the New York Times companion picture slide show. (Some stirring photos.)

0 Big Data and the Coming New Value Proposition for Disease Care and Wellness Management Providers

Disease Management Care Blog readers know that the its latest interest is "Big Data." While the researcher-DMCB has played in the sandbox of some insurance claims data sets, the idea of combining and combing through multiple terrabytes of clinical and public data remains a topic of endless fascination. It knows its not alone.

So, it was only a matter of time until one of the major clinical journals published an article on the topic. JAMA has stepped forward, and not a moment too soon.

Its "must reading" for the disease and care management provider community.

Drs. Murdoch and Detsky point out that Big Data offers four value propositions:

1. Observational correlations may generate insights that cannot be found using standard research approaches. Scanning text for key words in electronic record systems involving hundreds of thousands of patients may find associations or trigger early warnings faster, quicker and cheaper than any formal scientific protocol or clinical trial.

2. Those insights, especially since they can be tailored to fit the circumstances of an otherwise unique patient, can be used to guide diagnosis or treatment. Physician judgement cannot be replaced, but if Big Data points out that there were other patients with a similar pattern of illness who responded best to one treatment versus another, patient outcomes could improve.

3. A Big Data approach to genomics can correlate genetic information with outcomes and further guide therapy. While the DMCB still wonders if "genomics," outside some narrow anecdotes, will always remain the science of the future, Big Data may turn out to be the key to finally unlocking its potential.

4. Since Big Data, by its very nature, can combine clinical information to other personal data (the foods youve bought or your driving history), Big Data will necessarily tilt toward the patient-consumer and away from the health care system. Not only does permission for access lie with the patient, but the insights will be less about sickness and more about wellness.

The authors do a good job of pointing out that there are plenty of challenges. Most doctors dont get it, privacy laws could be over-interpreted or enforced, it remains to be seen who will pay for it and Big Data is still in its infancy.  The DMCB also points out that while Medicare has just discovered that alternative research innovations are possible, Big Data promises to eclipse those approaches (like traditional time series analysis, propensity matching), again making CMS a day late and another dollar over budget.

The implications for the care management and population health community are considerable. The industry has amassed years of intellectual capital in the science of predictive modeling and Big Data is its next step. Many care management vendors have multiple clinical partners and already have access to terrabytes of data involving millions of persons. Not only is the math and the informatics well within reach, they also "get" the tilt toward wellness and consumer empowerment. Last but not least, if anyone can monetize a value proposition like this and turn insights into revenue (or "shared savings"), these nimble vendors can.

A DMCB prediction: while academics will write about Big Data in scientific journals, the care management industry will be doing it.  In fact, they probably already are.

Two particularly good quotes to use to impress your CEO and stymie your competitors:

"Data has gone from use to riches."

and

Economic theory describes the quantitative conversion of 3 kinds of inputs (capital, labor, and raw materials) into outputs (goods and services)...The current revolution in data management makes it clear that a fourth kind of input, information, will become just as important as these other inputs in the future of many industries.

0 Your New Weight Loss Lifestyle

(Article first published as Weight Loss is Just a Lifestyle Change Away on Technorati.)

Americans continue to struggle with weight loss, and yet the number of people who indicate they are actively trying to lose weight has steadily decreased. As a nation, we have become less concerned about the impact overweight and obesity will have on our quality and length of life, as well as the burden being placed on an already broken health care system.

The solution is well within our reach, and like every significant achievement, healthy weight loss requires time, planning and perseverance. The most important part of losing weight is to keep in mind that it’s not a diet, but a new lifestyle which must be followed every day. Virtually every diet is destined to fail when viewed as a temporary plan. Only a sustainable dietary modification program with proper exercise will result in permanent weight loss.

Keep an Electronic Food Journal

The best way to develop a weight loss plan is to keep an accurate food journal and record everything eaten in a day. Be honest with your quantities and weigh foods where appropriate. Using one of the many free online food calculators, input the journal results to receive the total calories consumed for each day. Most people are surprised to see the total number of calories, especially when eating out or frequenting fast food restaurants.

After a few days, begin to look at the types of food you eat regularly, especially the high sugar items and refined carbohydrates. While it may be true that each calorie has the same impact on weight regardless of the type, studies demonstrate that many people are metabolically sensitive to calories from high fructose corn syrup and highly processed wheat and corn based foods. From an evolutionary perspective, these are new food groups which create havoc in our body, as it leads to abnormal fat storage and weight gain.

Eat a Well Balanced Diet to Lose Weight

Many fad diets eliminate one or more of the major food groups, resulting in an unsustainable lifestyle and possibly even damaging your health. The only diet which can work is balanced and consists of reduced quantities of lean proteins, nuts, seeds, healthy monounsaturated fats and unlimited raw green vegetables. The key is to eat healthy quantities of green leafy vegetables such as spinach and spring mix so you become full. Resist the natural urge to eat processed and refined foods which are laden with calories and have been stripped of nutrients.

It’s important to slowly eliminate the most calorie dense food choices such as sweets, breads, fried foods, snacks and soft drinks. Most people can easily eliminate 500 calories per day simply by making a low calorie substitution. This is a good starting goal, as 3,500 calories dropped per week will result in 1 pound lost. Most women will want to target approximately 1,200 total calories per day, while men will need around 1,500 calories. Never go below 1,000 calories per day, as the body has certain energy requirements for normal metabolic function which may be jeopardized.

Compliment Diet with Exercise

No weight loss lifestyle plan would be complete without exercise. Physical activity is a great way to achieve an extended calorie burn, but more important are the health benefits from improved blood lipids and blood sugar control as well as lowered blood pressure. Exercise helps tone the different muscle groups in the body and modifies insulin resistance that can alter how fat is stored and burned. This has a direct effect on weight loss and will also lead to overall improved health as you age. A high intensity workout is not necessary, as just 20 minutes of moderate exercise on most days is enough to reap the rewards and fuel weight loss.

Americans continue to gain pounds at an alarming rate, and appear to have become complacent with their efforts to lose weight. Dedication is required to reach a proper weight, and can only be achieved by committing to a new lifestyle of healthy eating and physical activity. It’s difficult to make the changes necessary to reverse a lifetime of eating processed junk food, but the reward is a natural and healthy weight loss which can be maintained for life.

0 New Beverly Hills Diet

In the original Beverly Hills diet begins with 42 days of initiation is very tight. But the new system is more balanced diet recommends. In this type of diet is not just what and how much is consumed, but rather on what foods can be eaten together.
This is because when one of the foods consumed too much and mixed with different types of food that would make a functioning enzyme to metabolize these foods become confused that encourages weight gain.
Just as the fruit itself digestible and converted into nutrients in the intestine within 15-20 minutes. While carbohydrates takes 3 hours to digest, protein takes 10 hours or more, and almost never get fat consumption.
Steps taken to implement the new Beverly Hills diet
In doing this diet, protein is consumed with protein (and fat), carbohydrates are consumed with carbohydrates (and fat), while fruit consumption.
To start the day with fruit consumption can be enzymatically like pineapple, strawberries, grapes or watermelon. This fruit can be consumed without limit, but need to wait 1 hour before switching to the other pieces and it took 2 hours before eating carbohydrates, fat or protein.
If after eating the fruit and carbohydrate consumption, so a person can eat carbs without limit until a later time to consume protein. If when eating carbohydrates mixed a little protein, then about 80 per cent of everything consumed on the rest of the day should be protein.
Even so, people who undergo this diet allowed one time outdoor dining which between carbohydrate and protein should be combined, for example, eat shrimp with rice or meat with potatoes. But this should only be done once a day only.
If someone were to apply this diet to do well, then one can expect a decline in weight as much as 5-7 kg within 35 days of the program