The Paperless Clinical: Time to Query Resolution

 

As part of Target Health’s contribution to the adoption, implementation and feasibility of the paperless clinical trial, our position is that “it is all about the data.“

 

The following table analyzes the time from the generation of a manual query to the time of its resolution when data are entered in “real time“ and monitored in “real time“ in a paperless clinical trial. This Phase 3 paperless clinical trial used Target eCTR (eClinical Trial Record) as eSource fully integrated with Target e*CRF (EDC) and Risk-based (adaptive) Monitoring. While it may have taken 30 days to resolve all queries, 15% of queries were resolved on the day of issue, 77% within 5 days and 93% within 10 days. Congratulations to our monitors for this spectacular metric.

 

Time to Query Resolution

 

Days                N = 883            Frequency (%)

0                      130                              14.7

1-5                   548                              76.8

6-10                 145                              93.2

11-20               55                                99.4

21-30               5                                  100.0

 

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

Mussels Inspire Innovative New Adhesive for Surgery

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Mussels can be a mouthwatering meal, but the chemistry that lets mussels stick to underwater surfaces may also provide a highly adhesive wound closure and more effective healing from 1) ___. In recent decades bioadhesives, tissue sealants and hemostatic agents became the favored products to control bleeding and promote tissue healing after surgery. However, many of them have side effects or other problems, including an inability to perform well on wet 2) ___.

 

“To solve this medical problem, we looked at nature,“ said Jian Yang, associate professor of bioengineering at Penn State. “There are sea creatures, like the mussel, that can stick on rocks and on ships in the ocean. They can hold on tightly without getting flushed away by the waves because the mussel can make a very powerful adhesive 3) ___. We looked at the chemical structure of that kind of adhesive protein.“ Yang, along with University of Texas-Arlington researchers Mohammadreza Mehdizadeh, Hong Weng, Dipendra Gyawali and Liping Tang, took the biological information and developed a wholly synthetic family of adhesives. They incorporated the chemical structure from the mussel’s 4) ___ protein into the design of an injectable synthetic polymer. The bioadhesives, called iCMBAs, adhere well in wet environments, have controlled degradability, improved biocompatibility and lower manufacturing costs, putting them a step above current products such as fibrin glue and cyanoacrylate adhesives.

 

Fibrin glues are fast acting and biodegradable but have relatively poor adhesion 5) ___. They may also carry risk of blood-borne disease transmission and have the potential for allergic reactions due to animal-based ingredients. Cyanoacrylate adhesives — super glues — offer strong adhesion, rapid setting time and strong adhesion to tissue, but they degrade slowly and may cause toxicity, often limiting their use to external applications. Additionally, neither product is effective when used on wet tissue, a requirement of internal organ surgery, nor are there any current commercially available tissue adhesives or sealants appropriate for both external and 6) ___ use.

The researchers tested the newly developed iCMBAs on rats, using the adhesive and finger clamping to close three wounds for two minutes. Three other wounds were closed using sutures. The researchers reported their findings in a recent issue of Biomaterials. The iCMBAs provided 2.5 to 8.0 times stronger adhesion in wet tissue conditions compared to fibrin glue. They also stopped bleeding instantly, facilitated 7) ____ healing, closed wounds without the use of sutures and offered controllable degradation.

 

“If you want the material to stay there for one week, we can control the polymer to degrade in one week,“ said Yang. “If you want the material to stay in the wound for more than a month, we can control the synthesis to make the materials 8) ___ in one month.“ The iCMBAs are also non-toxic, and because they are fully synthetic, they are unlikely to cause allergic reactions. Side effects were limited to mild inflammation. “If you put any synthetic materials into your body,“ said Yang, “the body will generate some 9) ___.“

 

The researchers are now working on improving the formula. “We are still optimizing our formulation,“ said Yang. “We are still trying to make the adhesion strength even stronger“ to expand its use for things like broken bones where strong adhesion is tremendously important. The researchers are also looking at adding in components that could control infection. “We can introduce another component with anti-microbial properties, so it can do two functions at once,“ said Yang. The iCMBAs could eventually be used in a wide range of surgical disciplines from suture and staple replacement to tissue grafts to treat hernias, ulcers and burns. “There are so many applications that you can use this 10) ___ for to help in surgery,“ said Yang.

 

ANSWERS: 1) surgery; 2) tissue; 3) protein; 4) adhesive; 5) strength; 6) internal; 7) wound; 8) degrade; 9) inflammation; 10) glue

Old Testament Health and Shellfish

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The transmission of gastrointestinal infections (including typhoid fever) via polluted shellfish or water testifies to the wisdom of the Hebrews in warning against such sea food and impure water. In Judaism, the concept of “unclean animals“, or more accurately “impure animals“, plays a prominent role in the part of Jewish law that specifies which foods are allowed (kosher) or forbidden to Jews. These laws are based upon the Books of Leviticus and Deuteronomy, of the Torah and in the extensive body of rabbinical commentaries (the Talmud). The concept of unclean animals is also mentioned in the Book of Genesis, when Noah is instructed to bring into the Ark all sorts “of pure beasts, and of beasts that are impure, and of fowls, and of everything that creepeth upon the earth“.

 

Leviticus 11:2 “Speak to the children of Israel, saying, “These [are] the animals which you may eat among all the animals that [are] on the earth: “Among the animals, whatever divides the hoof, having cloven hooves [and] chewing the cud–that you may eat. “Nevertheless these you shall not eat among those that chew the cud or those that have cloven hooves: the camel, because it chews the cud but does not have cloven hooves, is unclean to you; “the rock hyrax, because it chews the cud but does not have cloven hooves, [is] unclean to you; “the hare, because it chews the cud but does not have cloven hooves, [is] unclean to you; “and the swine, though it divides the hoof, having cloven hooves, yet does not chew the cud, [is] unclean to you. “Their flesh you shall not eat, and their carcasses you shall not touch. They [are] unclean to you. “These you may eat of all that [are] in the water: whatever in the water has fins and scales, whether in the seas or in the rivers–that you may eat. “But all in the seas or in the rivers that do not have fins and scales, all that move in the water or any living thing which [is] in the water, they [are] an abomination to you. “They shall be an abomination to you; you shall not eat their flesh, but you shall regard their carcasses as an abomination. “Whatever in the water does not have fins or scales–that [shall] [be] an abomination to you. “

 

Again in Leviticus: “Of all the creatures living in the water of the seas and the streams you may eat any that have fins and scales. But all creatures in the seas or streams that do not have fins and scales – whether among all the swarming things or among all the other living creatures in the water – you are to regard as unclean. And since you are to regard them as unclean, you must not eat their meat; you must regard their carcasses as unclean. Anything living in the water that does not have fins and scales is to be regarded as unclean by you.“

Leviticus 11:9-12

 

For seafood or fish to be kosher, it must have fins and easily removable scales, like tuna, carp and herring. Shellfish generally, lobsters, shrimp, mussels, clams and oysters, are not kosher. Shell fish of any sort is considered an unclean food by the Jewish Code of Law. The reason they are called unclean food and forbidden is because they are all scavengers. Their purpose is to keep the earth, air and waters clean. That means unclean animals, eat or ingest toxins and waste but do not have the digestive systems to release them. That means they are absorbed into their flesh and cannot be cleaned of them, boiled, fried, grilled or baked out. You literally eat what they have eaten. A myriad of disease and other ailments are the result of people eating unclean foods.

 

Because of our understanding through science, we know that shell fish clean the oceans and are a potential death threat to the consumer if water reaches a certain temperature.  With climate change destruction, taking place around the world, we should consider shellfish, a key warning device, alerting humans, by sickening them, to the rising temperatures of the oceans.

 

Ancient tribes observed that clean fish have fins and scales: anchovy, bass, bluefish, carp, cod, crappie, drum, flounder, garfish, grouper, grunt, haddock, halibut, hardhead, herring, mackerel, minnow, perch, pickerel, pike, rockfish, salmon, shad, sheepshead, skipjack, smelt, snapper, sole, sunfish, tarpon, trout, tuna (albacore, bonita, yellowtail).

 

The ancients deemed shellfish and fish without fins and scales unclean because of the animal’s biology. Shellfish like shrimp, crab, lobster, oysters, scallops, and clams, as well as catfish, gar, swordfish, fresh water cod, and others are nature’s filter system; a way of keeping the water clean. These animals are scavengers, that eat dead and decaying animals, and any other pollutants they find, including those put there by man. They filter oceans, seas and lakes. As a result, they can maintain high levels of mercury, heavy metals, and industrial contaminants.

 

According to author Rex Russell, MD, “Shellfish can be placed in a body of water that is contaminated with cholera bacteria, and they will purify the water. Shrimp, oysters, crab, scallops and mussels are particularly efficient at this. They filter large volumes of water every day. Sewage laden with chemicals, toxins, and harmful bacteria, parasites and viruses become concentrated in those shellfish. The cause of cholera outbreaks in several areas has been traced to contaminated shrimp, crab, oysters and clams.“

 

Catfish (one of the most beloved fish in America), do the same thing, only in lakes and ponds.

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As we look at modern science and nutrition vs. the Old Testament there is an amazing overlap between the original ancient laws of clean and unclean and solid hygienic principles adhered to today. Next time you eat shrimp, look at it carefully after biting into it. Sometimes there is a dark line which represents the waste that has yet to be expelled, not to mention what else is in its system that can’t be seen. It is common knowledge that these creatures feed largely on the raw sewage and pollutants in the water. Prevention magazine carried an interesting article entitled “Shellfish Are Dirty and Dangerous.“ The author appeared reluctant to take a stand, but was committed to telling the truth on the sensitive subject. “They’re succulent; they’re delicious; they’re even nutritious. But, because of the nature of the mollusk and the sewage-like pollution of its habitat, we must in good conscience advise you to avoid shellfish, no matter how they tempt you, end even though those around you seem to be swallowing them with delight. The day of reckoning cometh. “Why are shellfish so dangerous? Because they are many times more polluted than the filthy waters they inhabit. “Unfortunately they choose to live and love and multiply in estuaries along coastal regions. These estuaries are particularly subject to the discharge of sewage, sewage effluent, and other water-borne pollution from municipal discharges, from suburban home drainage and agricultural runoff. “The polluted aspect of their habitat is one danger. The fact that they are filter feeders compounds the danger. “Oysters, for instance, because of their way of obtaining and absorbing food, have been found to concentrate polio virus up to 20 to 60 times the level of the surrounding seawater. “No other animal food offered on the menu of your favorite eating place would be served to you whole; complete with its intestinal tract.“

 

Over and over again outbreaks of hepatitis have been traced to the eating of seafood. After feeding on raw sewage, the creature is harvested and sold. The disease is simply cycled from man to mollusk and then back to man. Precisely because of this uncleanliness, the books of Leviticus and Deuteronomy forbid the eating of shellfish because they were considered unclean. Old Testament promotion of health believed that an animal that eats filth and waste and is potentially contaminated with parasites would make people sick; whereas an animal that processes its food properly and eliminates the toxins from its body would be far healthier.

 

Shellfish consists of lobster, shrimp, oysters, clams, crabs, scallops, and mussels. All shellfish can be a serious health risk. They are scavengers that live at the bottom of the ocean and eat the waste of other animals and the pollutants that man dumps into the ocean. Although only 0.1% of all shellfish consumed is eaten raw, that tiny percentage is responsible for a large proportion of reported food-caused illnesses. Poisoning from shellfish can come from bacterial or viral contamination. Generally adequate cooking eliminates this danger, but is it worth the risks in the long run. Poisoning can also arise from heat-stable toxins derived from the food that the shellfish have been eating. Shellfish are notorious for being high in mercury, heavy metals, and industrial contaminants in the environment because they’re bottom feeders that eat the ocean’s waste. Heavy metals and toxins can be dangerous to your health.

 

Thousands of years ago, the Old Testament prescribed dietary laws as a health precaution to help the human body function and to keep people from succumbing to disease.

Dengue Vaccine Shows Promise In Early-Stage Trial

 

Dengue fever, also known as breakbone fever for a reason, is prevalent in many tropical and subtropical regions of the world, and is caused by any of four related viruses — DENV-1, DENV-2, DENV-3 and DENV-4. Dengue fever is transmitted to humans by the Aedes mosquito. The World Health Organization estimates that every year, 50 million to 100 million cases of dengue occur worldwide, resulting in 500,000 hospitalizations of patients with severe disease, many of them in children. Symptoms include fever, headache, muscle and joint pains, and a characteristic skin rash that is similar to measles. In a small proportion of cases the disease develops into the life-threatening dengue hemorrhagic fever, resulting in bleeding, low levels of blood platelets and blood plasma leakage, or into dengue shock syndrome, where dangerously low blood pressure occurs.

 

Infection with one dengue virus results in immunity to that specific virus but not to the other three. Research shows that the likelihood of severe disease increases when a person is subsequently infected with a different dengue virus. This observation suggests that the ideal dengue vaccine would be tetravalent — that is, protective against all four dengue viruses.

 

According to results from an early-stage clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH and published online in the Journal of Infectious Diseases (17 January 2013), a candidate dengue vaccine has been found to be safe and to stimulate a strong immune response in most vaccine recipients.

 

The Phase I clinical trial was launched in July 2010 and led by principal investigator Anna Durbin, M.D., at Johns Hopkins Bloomberg School of Public Health in Baltimore. The study tested a single dose of each of four versions of the investigational dengue vaccine TetraVax-DV which was developed in NIAID’s Laboratory of Infectious Diseases. It is a live-attenuated vaccine, which means that the viruses it contains are weakened enough such that they do not cause illness but still can induce an immune response. Each of the four vaccines tested included different mixtures of components designed to protect against all four dengue viruses.

 

The final study analysis included 112 healthy men and women ages 18 to 50 years who had not previously been exposed to dengue or related viruses such as West Nile virus and yellow fever virus.

 

Study participants were randomized into four groups. In each group, 20 volunteers received a single 0.5-milliliter subcutaneous (under the skin) injection of one of the tetravalent candidate vaccine combinations, and eight others received placebo. All were monitored for immediate adverse reactions for at least 30 minutes after vaccination, and subsequently took their body temperatures three times daily for 16 days to check for possible adverse reactions. Participants also received a physical examination every other day up to Study Day 16, and then again on study days 21, 28, 42 and 180, when blood tests were also performed.

 

Results showed that all four candidate vaccine combinations induced antibody responses against each of the dengue viruses. However, one vaccine combination, TV003, appeared to induce the most balanced antibody response against the dengue viruses. A single dose of TV003 resulted in an antibody response to all four dengue viruses in 45% of participants and against three of the four viruses in an additional 45%. Overall, an immune response to at least three viruses was seen in 90% of vaccinees given TV003.

 

All four candidate tetravalent vaccines were found to be safe, and no participants experienced fever or dengue-like illness after vaccination. The most common side effect was a faint rash (in 64% of vaccinees and none of the placebo recipients) consisting of small, non-painful bumps on the arms and torso that resolved within five to seven days. The presence of the rash appeared to correlate with being white and having a stronger immune response to vaccination. Ninety percent of white vaccinees experienced a vaccine-related rash while only 35% of African-American vaccinees developed a rash. Further, 97% of white vaccine recipients (42 of 43) developed antibodies to at least three of the dengue viruses, compared with 60% of African-American vaccine recipients (22 of 37). It is unclear what caused this difference, but previous studies of severe dengue outbreaks in Brazil, Cuba and Haiti suggest that black people may have some inherent protection from dengue infection. Alternatively, unknown factors may have resulted in a weaker antibody response to the vaccine among African-American participants. According to the authors, additional research to evaluate racial differences in dengue infection and antibody response rates to dengue vaccines is needed.

 

TV003’s inexpensive production cost — less than $1 per dose — is critical to its potential use in developing countries. Manufacturers in Brazil, India and Vietnam — countries where dengue is prevalent — have licensed the vaccine technology for production and further evaluation. Phase II trials to evaluate the safety of TV003 and its capacity to create an immune response will begin soon in Brazil and Thailand.

Clinical Trial Begins New Treatment of For Niemann-Pick Disease, a Rare, Fatal Neurological Disorder

 

Target Health has been directly involved with the approval of 3 drugs for the treatment of orphan diseases and has received 11 Orphan Drug Designation for our clients in the following designations:

 

1.            Gaucher Disease – (NDA Approved 2012

2.            Hereditary angioedema – NDA Approved (2011)

3.            Debridement of 3rd degree burns in hospitalized patients (EMA Approval 2012)

4.            Scleroderma

5.            Osteonecrosis of the jaw

6.            Alagille Syndrome

7.            Burn progression in hospitalized patients

8.            Caries prevention, head and neck cancer

9.            Cushing’s syndrome secondary to ectopic ACTH secretion

10.          Edema-related effects in hospitalized patients with 3rd degree burns

11.          Growth Hormone

 

Niemann-Pick type C (NPC) is a lysosomal storage disease associated with mutations in NPC1 and NPC2 genes. NPC strikes an estimated 1:150,000 people. Approximately 50% of cases present before 10 years of age, but manifestations may first be recognized as late as the sixth decade. NPC is biochemically, genetically and clinically distinct from Niemann-Pick Types A or and B. In Types A & B, there is complete or partial deficiency of an enzyme called acid sphingomyelinase. In NPC, the protein product of the major mutated gene NPC1 is not an enzyme but appears to function as a transporter in the endosomal-lysosomal system, which moves large water-insoluble molecules through the cell. The protein coded by the NPC2 gene more closely resembles an enzyme structurally but seems to act in cooperation with the NPC1 protein in transporting molecules in the cell. The disruption of this transport system results in the accumulation of cholesterol and glycolipids in lysosomes. In NPC, large amounts of free or unesterfied cholesterol accumulates in lysosomes, and leads to relative deficiency of this molecule in multiple membranes and for steroid synthesis. The accumulation of glycosphingolipids in the nervous system has been linked to structural changes, namely ectopic dendritogenesis and meganeurite formation, and has been targeted therapeutically. Several theories have attempted to link the accumulation of cholesterol and glycolipids in the lysosomes with the malfunction of the NPC-1 protein. No FDA-approved therapies are available to treat NPC.

 

In 2009, the NIH Therapeutics for Rare and Neglected Diseases (TRND) program, selected NPC cyclodextrin as one of its initial pilot projects to repurpose cyclodextrin from its conventional use as an ingredient in other drugs to a therapeutic for this rare disorder. TRND supported animal toxicology studies to evaluate the safety of cyclodextrin and all necessary regulatory efforts and also supported the development of an NPC biomarker. The biomarker test detects in the blood a modified cholesterol molecule specific to neuronal cells in the brain that would increase as a result of treatment with cyclodextrin. TRND researchers and collaborators submitted the data in an Investigational New Drug (IND) application, and FDA has now agreed that there are sufficient data to start a Phase I clinical trial.

 

The NPC Phase I clinical trial will test multiple doses of cyclodextrin in nine patients. The team also is conducting a natural history study of NPC to collect health information from patients to understand how the disease develops. The natural history study is critical to understanding the clinical significance of a treatment for NPC patients. The goal of the Phase I clinical trial is to determine a safe dose of cyclodextrin that will support an expanded Phase II trial to begin to evaluate the effectiveness of the drug.

 

The NPC clinical trial is the fourth TRND project to advance to human clinical trials in the last 15 months. The three other clinical trials are evaluating treatments for sickle cell disease, chronic lymphocytic leukemia and hereditary inclusion body myopathy. TRND has a portfolio of 14 projects, which focus on rare and neglected tropical diseases.

Prenatal Inflammation Linked To Autism Risk

 

According to new findings published online in the journal Molecular Psychiatry (22 January 2013) and supported by the National Institute of Environmental Health Sciences (NIEHS), maternal inflammation during early pregnancy may be related to an increased risk of autism in children. The study found elevated C-reactive protein (CRP) in mothers with children who have autism. CRP is a well-established marker of systemic inflammation. Results from the study indicated that the risk of autism among children in the study was increased by 43% among mothers with CRP levels in the top 20th percentile, and by 80% for maternal CRP in the top 10th percentile.) and add to mounting evidence that an overactive immune response can alter the development of the central nervous system in the fetus.

 

According to the authors, elevated CRP is a signal that the body is undergoing a response to inflammation from, for example, a viral or bacterial infection, and the higher the level of CRP in the mother, the greater the risk of autism in the child. However, the authors cautioned that the results should be viewed in perspective since the prevalence of inflammation during pregnancy is substantially higher than the prevalence of autism and that the vast majority of mothers with increased CRP levels will not give birth to children with autism.

 

The study capitalized on a unique national birth cohort known as the Finnish Maternity Cohort (FMC), which contains an archive of samples collected from pregnant women in Finland, where serum is systematically collected during the early part of pregnancy. The FMC consists of 1.6 million specimens from about 810,000 women, archived in a single, centralized biorepository. Finland also maintains diagnoses of virtually all childhood autism cases from national registries of both hospital admissions and outpatient treatment.

 

The study analyzed CRP in archived maternal serum corresponding to 677 childhood autism cases and an equal number of matched controls. The findings were not explained by maternal age, paternal age, gender, previous births, socioeconomic status, preterm birth, or birth weight.

 

This work is expected to stimulate further research on autism, which is complex and challenging to identify causes. Future studies may help define how infections, other inflammatory insults, and the body’s immune response interact with genes to elevate the risk for autism and other neurodevelopmental disorders. Preventative approaches addressing environmental causes of autism may also benefit from additional research.

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

 

FDA Approves Gleevec for Children with Acute Lymphoblastic Leukemia

 

Acute lymphoblastic leukemia (ALL) is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated. Children with Philadelphia chromosome positive (Ph+) ALL have a genetic abnormality that causes proteins called tyrosine kinases to stimulate the bone marrow to make too many immature white blood cells. This leaves less room for healthy white blood cells needed to fight infection.

 

The FDA has approved a new use of Gleevec (imatinib), in combination with chemotherapy, to treat children with Ph+ ALL. It should be used to treat children with Ph+ ALL. Gleevec is a tyrosine kinase inhibitor that blocks the proteins that promote the development of cancerous cells,

 

Gleevec’s safety and effectiveness for this new indication were established in a clinical trial conducted by the Children’s Oncology Group, sponsored by the National Cancer Institute. The trial enrolled children and young adults 1 year and older with very high risk ALL, defined as patients with a greater than 45% chance of experiencing complications from their disease within five years of treatment. Ninety-two patients with Ph+ ALL were enrolled in the trial and divided into five treatment groups, with each successive group receiving a greater duration of Gleevec treatment in combination with chemotherapy.

 

Fifty of the Ph+ ALL patients received Gleevec for the longest duration, and 70% of these patients did not experience relapse or death within four years (event-free survival). Results also showed patient deaths decreased with increasing duration of Gleevec treatment in combination with chemotherapy. The most common side effects included decreased levels of infection-fighting blood cells called neutrophils; decreased levels of blood platelets, which assist in blood clotting; liver toxicity; and infection.

 

Gleevec was granted accelerated approval in 2001 to treat patients with blast crisis, accelerated phase or chronic phase Ph+ chronic myeloid leukemia (CML) who have failed interferon-alpha therapy. It has since been approved to treat several conditions, most recently regular approval to treat children newly diagnosed with Ph+ CML (2011) and regular approval to treat adults whose Kit (CD117)-positive gastrointestinal stromal tumors (GIST) have been surgically removed (2012).

 

Gleevec is marketed by East Hanover, N.J.-based Novartis

Everyone Should Eat More Mollusks

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Mollusks comprise one of the largest animal groups on land, in oceans, or in fresh water. Bivalves, the class of mollusks that includes clams, mussels, oysters, and scallops, are extremely rich in a unique combination of nutrients that promote health. Think red meat is your best bet for protein and iron?  Think again. Bivalves are a superior source of low-calorie protein loaded with iron. In addition, they’re virtually fat free and are packed with zinc and vitamin B12.

 

Consider clams: They’re super-rich in iron, manganese, phosphorus, vitamin B12, vitamin C, and are a good source of niacin, potassium, riboflavin, selenium, and zinc. Three ounces of raw clams will only cost you 63 calories, but you’ll get 11 grams of protein, 66% of the daily recommended amount for iron, and 700% of the daily recommended amount for vitamin B12. Chinese medicine recommends clams for treating hemorrhoids.

 

Mussels are high in iron, manganese, vitamin B12, and selenium and are a good source of phosphorus, riboflavin, thiamin, vitamin C, and zinc. Three ounces of raw blue mussels contain only 73 calories, but you’ll get 10 grams of protein, 19% of the daily recommended amount of iron, upward of 50% of the recommended amount for selenium, and more than 100% of the recommended amount for manganese, which aids in wound healing and optimal brain functioning. In Chinese medicine, mussels are used to treat impotence, low back pain, and goiter.

 

Six medium raw oysters, which is roughly equivalent to three ounces, provides 31% of the daily recommended amount for iron and 6 grams of protein for just 57 calories. Oysters are high in iron, B12, zinc, selenium, manganese, magnesium, and phosphorus. What’s more, oysters contain the amino acid tyrosine, which is converted into dopamine in the brain, resulting in a mood and mental boost.

 

Scallops are an excellent source of tryptophan and a good source of protein, vitamin B12 (cobalamin), phosphorus, magnesium, omega-3 fatty acids, and potassium. To give you an idea how scallops measure up, three raw ounces provide 14 grams of protein and a good amount of B12, all for 75 calories.

 

Vitamin B12, is a power player in the world of nutrition. It takes on a crucial role in the normal functioning of the brain and nervous system, aids in digestion and proper absorption of nutrients from foods, fights chronic fatigue, and helps expedite the release of melatonin, improving sleep patterns and resulting in better, more restful sleep. B12 also helps maintain red blood cells and nerve cells and aids in the formation of DNA.

 

Zinc helps balance blood sugar, sharpens smell and taste, and supports immune function. Zinc also plays an important role in supporting male reproductive health. Inadequate zinc has been shown to adversely affect sperm quality, while zinc supplementation has shown benefits in overall sperm health, including higher sperm counts. Other good sources of zinc include sea vegetables.

 

Quick and healthy tip: Mussels, oysters, and bay scallops are on Oceans Alive’s Eco-Best list; clams make the Eco-OK list. You can easily locate canned clams and mussels, and oysters and frozen scallops at your local grocery. Toss with tomato sauce, fresh herbs, and whole-grain pasta for a quick and healthy meal.

Drunken Mussels

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This seriously delicious mussels recipe is one of the quickest shellfish preparations and easy too. Bring a flavorful, wine-based broth to a boil, add mussels and cover; cook until they open, and eat. That’s it!

 

Enough for two people

 

Ingredients

 

2 Tablespoons butter or canola oil ( we are not using butter)

4 cloves garlic, minced

Warm bread or rolls

1/2 teaspoon red pepper flakes, or to your taste (we are not using this either)

1 lemon, zested

2 cups white wine

Freshly ground black pepper to taste

2 pounds mussels, cleaned and debearded

1 cup chopped fresh flat-leaf parsley

2 lemon wedges for garnish

 

Directions

 

1. Melt butter or canola oil in a large stock pot over medium heat. Add garlic and let sizzle for about 30 seconds.

2. Season with red pepper flakes (optional-we don’t use this) and lemon zest, stirring for about 45 seconds.

3. Quickly pour the wine into the pan and season with black pepper (freshly ground or fine black pepper will do).

4. Bring sauce to a boil, stir in mussels, and cover immediately. Shake pot and let boil for 1 minute.

5. Stir mussels, replace cover, and let boil for 2 more minutes. The shells will begin to open. Stir in parsley, cover pot, and cook until all shells are open, 1 to 3 minutes.

6. Ladle into wide rim soup bowls, with lemon wedges.

7. Serve with the warm bread and/or rolls to sop up the delicious sauce, your favorite salad, a fruit and cheese platter and glasses of chilled white wine, or in this weather, even better, consider mulled wine.

 

You’re all set for a warm and cozy meal time with your favorite person.

Make your own fire!

 

Mulled Wine – Cheers!

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Cheers!

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Photo: Mulled Red Wine

 

Easy Mulled Wine Recipe

 

1. Toss 4 wide strips orange zest with 1/2 cup sugar substitute like Splenda or Agave. Set aside 1 hour.

2. Simmer 1 bottle red wine, 1/2 teaspoon each whole cloves and peppercorns, 3 star anise pods, 2 cinnamon sticks, 1 bay leaf, 1 whole nutmeg, and the sugar sustitute mixture to taste over medium heat, for 15 minutes.

3. Ladle into glasses, leaving the spices and zest in the pan.

4. Garnish with cinnamon sticks and a small peal of orange.

 

 

Cheers!

The Inaugural:

Parsing the Speech

 

By Mark L. Horn, MD, MPH, Chief Medical Officer, Target Health Inc.

 

At first blush reviewing the President’s second inaugural address seems an odd task for this commentary, but I will try and connect some dots. Often, political rhetoric seems intended to generate passionate anger rather than thoughtful action. Worse, words are often used to obfuscate and confuse rather than convince and clarify. Whatever your positions on health care and social policy generally, the country got a rare and purifying example of verbal precision from our President on Martin Luther King’s birthday. The setting was ideal and the language clear. We now have a good sense of where President Obama wants to take the country and a chance, before the detailed bargaining begins, to predict the impact on the Affordable Care Act (ACA) and health care policy overall.

 

Two phrases resonate: 1) “They (speaking of Medicare, Medicaid, & Social Security) do not make us a nation of takers. They free us to take the risks that make this country great“; and, 2) “we reject the belief that America must choose between caring for the generation that built this country and investing in the generation that will build its future.“

 

Several elements of the rhetoric above are striking. First is the inclusion of Medicaid, a means-tested program designed for the poor, with Medicare and Social Security, programs designed for all and for which eventual beneficiaries pay into. It is fair to say that these programs are generally categorized separately by the public, especially the employed “middle class“ population that politicians so often address. Lumping them, as the President has done, suggests he intends to fight strongly to preserve Medicaid from, for example, opposition Party efforts to ‘block grant’ the federal contribution to the states. His statements suggest he will likewise oppose efforts to make significant structural changes to Social Security and Medicare although these programs are at less risk as a consequence of their profound support from powerful constituencies and are therefore less dependent upon his protection.

 

More importantly, is his obviously intentional rejection of the implication that reliance upon these programs somehow suggests that one is a ‘taker’. This description, clearly extracted from the just finished Presidential campaign, was, I believe, an elegant way to reinforce the oft stated notion that elections matter.

 

If one notion transcended the campaign as an addition to the American political landscape, it is the rhetorically novel and clearly demeaning description of those among our fellow citizens reliant upon government assistance as ‘takers’. Our President has now made it undeniably clear that he rejects this notion absolutely and will govern accordingly.

 

We can anticipate a full court press to implement the Affordable Care Act, including its originally intended expansion of Medicaid. The impact upon Social Security and Medicare is less clear, since among the beneficiaries of these programs are many individuals who are not vulnerable and could easily tolerate diminished benefits. Were I a bettor, I’d wager that Administration efforts to cut these programs will focus on increasing payments from, or decreasing payments to, the more affluent. As with taxes, the struggles will then focus on the definition of affluent.

 

In any event, lingering doubts about the principals underlying Administration social policy or its approach to the societal safety net should, following this speech, be gone. We can now get down to the business of implementing the ACA, adjusting entitlements, and remaining solvent.

 

We shall discover whether physical, fiscal, and mental health can be concurrently preserved.

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