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Health Care Today

Gingrich to call for health care repeal in Iowa

Former House speaker Newt Gingrich will call for repeal of the nation’s health care law and stress his opposition to a federal mandate that everyone obtain insurance coverage, as he makes his first presidential campaign foray into Iowa.

USA TODAY’s Susan Page writes today that the GOP presidential nomination is now wide open because former Arkansas governor Mike Huckabee has opted to skip next year’s presidential race. Nowhere is that more true than in Iowa, which holds the nation’s first presidential caucuses nine months from now.

The Iowa caucuses are a test of a candidate’s organizational strength because it requires a presidential hopeful to get his or her supporters out on a cold, wintry night to one of more than 1,700 precinct meetings — the first step to becoming an all-important delegate for the presidential nominating convention.

Huckabee won the 2008 Iowa caucuses, in large part because of his appeal to social conservatives in the state.

A spokesman for Iowa Gov. Terry Branstad told Politico that the governor will tell his fellow Republicans today to step up their campaigning and go after Huckabee’s supporters.

“Iowa is a full-spectrum state, and everyone — including evangelicals — wants someone who will articulate a message of job creation and slashing the federal debt,” Branstad’s communications director Tim Albrecht told Politico. “The person who best exhibits those leadership qualities will do well in Iowa, and they should build a campaign there to prove it.”

Gingrich will talk about health care and other issues on a 17-city tour, beginning with a speech to the Kiwanis Club in Dubuque. His campaign says he’ll talk about a “patient, innovation rich” health care system for the 21st century.

The current health care system “has no incentives to provide better care or to lower costs,” Gingrich says. “Consumers have little information on which to base their health care decisions because they have no data on who provides the best care and what the cost is.”

Former Massachusetts governor Mitt Romney, considered the front-runner for the GOP presidential nomination, outlined his principles for a health care overhaul last week. The issue is a political liability for Romney, who signed into Massachusetts law a health care plan that includes a mandate to obtain insurance coverage that is similar to the one in federal law that Romney, Gingrich and other GOP candidates want to repeal.

Romney be in Las Vegas today to visit a fundraising phone bank and to participate in a townhall meeting on Facebook.

Meanwhile, there could be some indication of the presidential campaign plans of Donald Trump. NBC announced its prime-time schedule yesterday and The Celebrity Apprentice will go on — with or without the real estate mogul saying “you’re fired” to the show’s participants.

“If he decides to run for president and is unavailable to do the show, we will bring the show back and there will be somebody else sitting at the head of the boardroom table,” NBC entertainment chief Bob Greenblatt said.

Daily check up: Patrick’s payment bill to be heard today

A hearing on payment plan: A legislative committee this morning will vet Governor Deval Patrick’s proposal to dramatically overhaul the way that doctors and hospitals are paid, shifting from a system in which they are paid for each service provided to one based on a patient’s overall care. The Associated Press reports that Patrick wants the bill on this desk by fall, but lawmakers have said they will take their time. Check back here throughout the day for updates.

Rhode Island’s Medicaid experiment: Republicans lawmakers who want to overhaul Medicaid by capping state payments and giving governors more flexibility in managing the money have pointed to Rhode Island as a success story. The state in 2009 cut just such a deal with the federal government, capping its payments through 2013. The health secretary who negotiated the deal, a Republican, says it has saved the state tens of millions of dollars. Janet Roberts of the New York Times reports, his successor, a Democrat, says he can’t find those savings.

Health care gone mobile: Patients have access to a growing number of mobile applications to help them track their weight, heart rate, and medications. Marion Davis writes for the Globe about the Boston-area companies developing the apps and how they changing the way we interact with doctors and get involved in our care.

Interpreting the pregnant pause: A Charlestown company is developing a tool to analyze not what patients say but how they say it. Through pauses in speech, stuttering, and the tone or pace of a person’s voice, Cogito Health says it can identify people at risk for depression or unlikely carry out a plan for managing their chronic disease. Globe reporter Carolyn Y. Johnson writes that the company believes it may even be able to determine when a patient’s says yes to attending a followup visit but really means no.

Kindred Healthcare Announces Senior Notes Offering

Kindred Healthcare, Inc. (the “Company” or “Kindred”) (NYSE:KND) today announced that it is planning to issue an aggregate principal amount of up to $550 million of senior notes due 2019 (the “notes”) to qualified institutional buyers in accordance with Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”) and to certain non-United States persons in offshore transactions in accordance with Regulation S under the Securities Act. Kindred intends to use the net proceeds from the sale of the notes and borrowings under certain senior secured credit facilities to fund its previously announced acquisition of RehabCare Group, Inc. (“RehabCare”) (NYSE:RHB) and to repay outstanding indebtedness of Kindred and RehabCare. The notes are expected to be guaranteed by substantially all of Kindred’s domestic 100% owned subsidiaries, including, following the acquisition, RehabCare and its domestic 100% owned subsidiaries.

The notes have not been registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States without registration under the Securities Act or an applicable exemption from registration requirements. This announcement does not constitute an offer to sell, or the solicitation of an offer to buy, any securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful.

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements regarding the Company’s expected future financial position, results of operations, cash flows, financing plans, business strategy, budgets, capital expenditures, competitive positions, growth opportunities, plans and objectives of management and statements containing the words such as “anticipate,” “approximate,” “believe,” “plan,” “estimate,” “expect,” “project,” “could,” “should,” “will,” “intend,” “may” and other similar expressions, are forward-looking statements.

Such forward-looking statements are inherently uncertain, and stockholders and other potential investors must recognize that actual results may differ materially from the Company’s expectations as a result of a variety of factors, including, without limitation, those discussed below. Such forward-looking statements are based upon management’s current expectations and include known and unknown risks, uncertainties and other factors, many of which the Company is unable to predict or control, that may cause the Company’s actual results or performance to differ materially from any future results or performance expressed or implied by such forward-looking statements. These statements involve risks, uncertainties and other factors discussed below and detailed from time to time in the Company’s filings with the Securities and Exchange Commission (the “SEC”).

Monday morning political briefing

President Obama will be back in Boston for a fund-raiser Wednesday, a week after potential GOP opponent Mitt Romney vowed to repeal Obama’s health care law. Meanwhile, the public has a chance today to weigh in on legislation aimed at cutting costs from Romney’s health-care reform in Massachusetts.

Race to 2012

Former Massachusetts Gov. Mitt Romney will be chatting with supporters this morning in Nevada. Although Romney hasn’t formally announced his presidential run, he has been ramping up and is holding a major fund-raising event for his exploratory committee today. Voters in the Granite State, meanwhile, will get a visit from former Utah Gov. Jon Huntsman Friday.
The Senate will unveil its version of the state budget Wednesday, and the most highly anticipated portion of the legislation is the potential inclusion of municipal health-care reforms. The House version, including a measure stripping collective bargaining rights from municipal unions in an effort to cut costs, and lawmakers who supported the bill are still hearing from unhappy union members.

LAST WEEK’S FEEDBACK:

Should legislators lower the age of eligibility for a driving learner’s permit?

Yes: 15 percent

No: 85 percent

“No, the Legislature should not lower the age of eligibility to have a learner’s permit. Kids today don’t take their responsibilities as seriously as we did when we were younger,” said one Herald reader.

Scott Brown’s wild ride

The 2012 race for re-election is in full swing now that Democratic Newton Mayor Setti Warren announced he’s running against Brown. While Brown has made low-key visits across the state, Warren continues his well-publicized campaign tour this week at a breakfast in Methuen tomorrow and a delegate dinner in Ipswich Wednesday.

Acne Treatment Today

New prescription treatment allows Canadians to manage acne better

Galderma Canada today announced Canadians now have access to a new once-a-day combination topical acne treatment designed to help people with mild to moderate acne. Tactuo™ is the first prescription topical acne gel to combine adapalene (0.1 per cent) with benzoyl peroxide (2.5 per cent). When used together, the two ingredients work effectively to unplug blocked oil glands and eliminate acne-causing bacteria, providing fast and visible results as early as the first week of use1. Tactuo™ can now be prescribed for patients who suffer from acne.

“Acne can be a very tough experience to deal with because it is highly visible for sufferers and caused by a multitude of factors. Patients often become frustrated with multiple treatments to rid their blemishes,” says Jerry Tan, MD, FRCPC, Adjunct Professor, Schulich School of Medicine and Dentistry, University of Western Ontario. “Tactuo™ allows patients to manage acne with one combined treatment, giving them the ability to concentrate on their lives instead of their skin. We are thrilled that Canadian patients now have access to this novel product.”

Acne affects more than five million Canadians2, with 80 per cent of those between the ages of 12 and 243. Although acne is most commonly seen as a stage of puberty, it can also begin in adulthood, with 75 per cent of adult acne occurring in women4.

Tactuo™ offers acne patients an easy-to-apply combination gel, which requires only one application per day before bed time. In most countries, Tactuo™ is marketed under the name Epiduo™, and it is already the number one prescribed topical acne medication in the U.S. The availability of Tactuo™ in Canada reinforces Galderma’s ongoing commitment to the future of dermatology by providing innovative treatment options for patients.

Acne affects millions of Canadians, and it is a common myth that it will disappear without the use of any medication. “If left untreated acne can worsen, leaving unwanted scars on an individual’s skin,” says François Fournier, President, North America, Galderma Laboratories, L.P. “As the worldwide industry leader in the field of dermatology, our goal at Galderma is to make Canadians aware that individualized treatment approaches to the management of acne are available.”

A Tactuo™ clinical trial published in 2007 in the Journal of the American Academy of Dermatology demonstrated that Tactuo™ reduced the median number of total acne lesions by more than 50 per cent at the end of the 12-week study, which was significantly better than monotherapy with either adapalene (35.4 per cent median reduction in total lesion count) or benzoyl peroxide (35.6 per cent median reduction in total lesion count) alone.5

“The need for an effective once-a-day acne treatment was clear given the prevalence of acne among Canadians and the absence of a similar combination therapy,” says Wendy Adams, General Manager of Galderma Canada Inc. “We believe that as in the U.S. and other countries, Tactuo™ will become the product of choice for acne patients. This is a unique, effective combination, which provides quick, visible results that are sustained over time. It’s an exciting time for Canadian acne patients and Galderma Canada.”

Tactuo™ is now available for prescription and at pharmacies across Canada. Patients should speak with their family doctor or dermatologist to learn more about Tactuo™ and its suitability for their skincare needs.

The Surprising Strategy That Cleared My Acne

Different from the whiteheads and blackheads that afflict many a high school teenager’s morning, cystic acne is made of achingly large and swollen bumps that form nodules deep beneath the skin’s surface. You can usually feel one ‘cooking’ for awhile before it jumps out in all its crimson glory, fated to take up residence so long on your face for so long, I used to joke that I should start charging rent.

From antibiotics to Retin-A creams to a purge of all oil-containing cosmetics in my vanity and gulping down copious amounts of water like a fish, I tried every Cosmo tip and dermatologist’s prescription. I ordered ProActiv kits under the glow of the infomercial midnight hour, and succumbed to the cutting words and extractions of estheticians who told me it was all my fault for not taking care of my skin properly. (The solution entailed seeing them monthly, of course.)

When not even fancy new microdermabrasion and laser treatments would stop the breakouts and I stopped short of trying Accutane for fear of the freak-tastic possible health effects (balding and stomach ulcers are not usually on top of my to-do list), I finally relegated myself to a lifetime of applying a daily face of heavy makeup to camouflage the unsightly bumps and purplish discoloration that breakouts left in their wake.

It was at this point when a friend mentioned she had heard that dairy could be a cause of cystic acne. In my countless visits to every kind of ‘skin expert’ out there, no nutrition-based plan had ever been prescribed. Cheese addict that I was, it seemed a painful proposition to part with my comfort food — but I was desperate. So I decided to go dairy-free for a solid two weeks as an experiment. After all, I told myself, I had tried far stranger and more arduous regimes. And if nothing happened, I could always abate my disappointment with a slice of pepperoni pizza.

During those two dairy-free weeks, something happened that I had never witnessed in all my years of high school, college and beyond: My acne breakouts ceased.

I was speechless. How was it that not a single skin expert I had seen all those years had ever once mentioned a link between food and breakouts as a possibility to me? In fact, I had once even asked a dermatologist if foods like cheese and chocolate could cause breakouts, and was only told with a shrug that there was no scientific evidence linking the two.

Reflecting on all of this now after well-earned time spent enjoying a clear complexion, I asked famed medical-turned-holistic doctor, Manhattan’s Dr. Frank Lipman, how this could be.

“I’m not sure why traditional dermatologists don’t recognize the link, because it is so very clear. Then again, doctors don’t believe that diet has an effect on many diseases. It may be because we aren’t taught about nutrition in Medical School,” explains Lipman.

Harder yet was finding an explanation as to why dairy can have such a profoundly negative effect on the skin. Again, I was looking in the wrong place by searching traditional medicine for the answer. It takes an expert in the science of nutrition, and how the body processes food, to get to the heart of the matter.

Another medical-turned-holistic doctor, Dr. Susan Blum of Rye Brook, New York, says that sugar causes inflammation in the body, which is often reflected in acne — an inflammatory condition of the skin. White sugar and dairy products, which are high in milk sugars, are prime triggers of this kind of inflammation inside the body.

There’s also another way that sugar whips acne eruptions up into a frenzy. “Many people with acne have too much yeast in their digestive tract, and yeast love sugar. So when you eat sugar, the yeast have a party, and grow. Your skin has yeast in the sebaceous glands,” explains Blum, of the microscopic cells that secrete the oil known as sebum in the skin.

“When yeast grows from the sugar, your skin reacts against it. Something about the dairy sugar is especially reactive for the yeast in the skin, so I suspect that is also something else in the dairy that causes a yeast reaction,” adds Blum.

When it comes to what else could be floating around in your dairy products, the options nowadays are endless.

“There are over 60 hormones in an average glass of milk. The process of pasteurization eliminates many of the beneficial components of milk, and homogenization creates fats that are foreign to most human digestive systems,” says Lipman.

Now before you all think I’m writing a dissertation on dairy as the anti-Christ, let me make it clear that I still enjoy some here and there. Just because you decide to eliminate something from your diet doesn’t mean that you have to abstain from it for the rest of your life, or else risk lightning striking you down as you pluck away at a piece of string cheese.

Once I cleared my system from the build-up of eating so much dairy by going off of it cold for several weeks, I’ve found that a yogurt parfait or spinach quiche here and there have no adverse reaction on my skin now. I’ll even enjoy a slice of pizza or toasted bagel with cream cheese as a treat occasionally, although I often do get a red bump afterwards. I’m a New Yorker, after all.

But in addition to drastically cutting down on dairy, I’ve also flooded my diet with anti-inflammatory foods that help balance, hydrate and heal skin from the inside, too.

Celebrity nutritionist Kimberly Snyder is launching a book this month, The Beauty Detox Solution, that dedicates an entire chapter to the ill skin effects of dairy. With image-conscious clients on her roster, she hones in on the foods that best combat an inflammatory reaction in the skin.

Snyder recommends incorporating nutritionally dense leaves like kale and romaine into your daily diet, as well as antioxidant-rich fruits and veggies that burst with flavor and color. Zinc promotes the repair of skin cells, and can be found in pumpkin seeds, sunflower seeds, pine nuts and coconut. You can also take 30mg of zinc citrate a day.

“Good” fats like those found in avocado, nuts and fish, will help keep skin healthy and glowing. Incorporating green smoothies into your diet, which I do as a breakfast ritual every day that gives me a clear mind and focused energy in addition to clearer skin, is a great way to start your day with a knockout punch to inflammation. I’ve included two signature recipes by Lipman and Snyder at the end of this story as options.

It’s of course ideal to buy organic when it comes to fruits and veggies, though if you’re budgeting, The Environmental Working Group has this handy list of the most important foods to buy organic, as well as those where organic doesn’t matter as much.

Yet don’t let the price tag of organic foods be the make-or-break factor for your decision to eat a skin-clearing diet.

“If you can’t afford organic, don’t let that deter you. Wash your produce extremely well, and you can dilute some apple cider vinegar in a soak to help remove some of the waxes and pesticides,” offers Snyder.

And remember; no matter how much good you do for your skin, you’re not going to see results unless you cut down or out the inflammatory factors. That means dairy and sugar — and according to Blum and Lipman, can also include gluten and factory-farmed meats.

Gluten, the chewy glue-like bond that comes from wheat and related items like rye and barley, can be difficult to avoid in our carb-centered society, but multitudes of gluten-free options are springing up in grocery stores and on menus alike, now that more people are trying to avoid the often troublesome ingredient in a quest for more balanced energy and health.

After going on a gluten-free stint (I now keep about 60 percent gluten-free), I can attest to the further skin-enhancing and energizing effects of freeing your diet from its doughy grasp.

Another bonus? Since aging is essentially a disease of inflammation, eating an anti-inflammatory diet will also help combat wrinkles, sagging, dry skin, and other telltale signs of age.

Friends ask me all the time how I can cut down on so much ‘fun’ food. With my palatte cleared of the junk and processed foods, I found that my taste buds readjusted pretty quickly, and I can savor the “good stuff” as far more flavorful and rich now.

I also rapidly got used to the taste of clear, beautiful skin and an overall sense of wellness and energy.

Triple whammy improves acne outcomes

Using a triple combination therapy for patients with moderate to severe acne vulgaris shows significantly improved outcomes, a study suggests.

A total of 378 patients were randomly assigned to receive 300mg lymecycline orally once daily given in combination with either topical adapalene 0.1% and benzoyl peroxide 2.5% or a vehicle gel, for 12 weeks.

Both groups showed a significant reduction in inflammatory and noninflammatory lesions at week 12, although patients taking the combination therapy displayed a faster onset of action from week two for non-inflammatory lesions and week four for inflammatory lesions.

Patients in the combination group showed a significantly greater reduction in total lesion count at 12 weeks – 74.1% – than those in the vehicle group – 56.8%.

The success rate – determined by clear or almost clear skin – was significantly higher in the combination group, at 47.6% than vehicle group, at 33.7%.

Lead researcher Professor Brigitte Dréno, head of the department of dermatology at the university hospital Nantes concluded: ‘These results demonstrated the clinical benefit of combining adapalene and benzoyl peroxide with lymecycline in the treatment of acne vulgaris.’

Got wrinkles, acne, or dark spots? Midland doctor says HydraFacial can help

Everyone wants better skin. Now a new machine claims to use science to help you get a smooth and beautiful face.

It is called the HydraFacial™, and its available at the Beauty by Rx Medical Spa, owned by Dr. Steven Morris.

The treatment first exfoliates your skin, while infusing it with serums.

These serums hydrate your skin, and specific serums can be used to treat different skin conditions, such as acne, dark spots, and even wrinkles. It also has light attachments that can treat discoloration or acne.

“There is not anybody that is not going to benefit from it,” said aesthetician Michelle Clickner.

Clickner works at Beauty by Rx.

I decided to test it out. After the intense exfoliation treatment, the machine extracts impurities from your pores.

“Can you feel the pressure, the suction of it?” asks Clickner.

I can. It is definitely an intense treatment.

“It is basically vacuuming out your skin,” I respond.

Right after the treatment my skin appeared red and irritated. I was disappointed. One week later though some acne and dry skin that I had been unable to get rid of for months started to clear up.

Clickner says it isn’t just about keeping your skin looking good, it is about keeping your skin healthy. The antioxidants in the serums promote cell health.

“People don’t realize what is available out there, and skin care has advanced so much.”

Alma Lasers pixel modules for aesthetic fractional laser resurfacing

Alma Lasers Introduces the iPixel Fractional Ablative Technology

Unique Roller Handpieces Glide Across the Skin to Dramatically Reduce Treatment Time While Delivering Safe, Effective Energy for Skin Rejuvenation

BUFFALO GROVE, Ill.,Alma Lasers Ltd., a global leader in laser, light, radiofrequency and ultrasound-based aesthetic treatment devices, today announced the launch of its new iPixel series of innovative pixel modules for aesthetic fractional laser resurfacing.

The iPixel CO2, and the iPixelEr—each feature Alma’s roller-style technology which delivers fast, safe treatments with great maneuverability and versatility. This innovative design allows the physician to glide the laser along the patient’s skin smoothly, delivering precision and an effective ablative treatment in a fraction of the time.

With Alma’s unique modular platforms, each of the new iPixel series modules can be used with existing Alma systems. This enables treatment providers the advantage of offering another option in safe and effective treatments without the need to purchase additional systems that take up valuable office space. “The iPixel series applicators are rolled across the skin,” said Alma Lasers CEO Dr. Ziv Karni. “All modules pulse energy into the thermal ablative processes while channeled through a single row of seven pixels.”

In the case of the iPixelEr, for use with the HarmonyXL, the energy delivered is impressive while treatment time is cut in half. For a limited time, the HarmonyXL is now available with all three applicator tips — the iPixelEr, the 7X7 stationary and the 4mm Erbium tips — allowing skin care professionals to choose the right technology for each patient’s needs.

The iPixelCO2, for use with the Pixel CO2 system, channels 70 Watts of energy into only seven pixels, and pulses are released as the roller wheels turn, regardless of the speed at which the handpiece is moving. “While the rollers speed up the treatment, the energy per laser spot causes fractional ablation leading to improved patient and physician satisfaction,” Karni said. “With the iPixel, the removal of fine lines, wrinkles and post-acne scars and skin rejuvenation is quicker without compromising results.”

“All skin care professionals are looking for faster, more efficient technologies without the need for costly disposables to meet the demands of time-pressed patients and revenue stream objectives. These modules provide outstanding advantages to professionals seeking the best results for their patients and practice,” said Avi Farbstein, EVP/GM of North America.

Mental Health Today: Mental health budget targets youth

Mental health budget targets youth

Prime Minister Julia Gillard has called early intervention the centrepiece of her government’s $2.2 billion commitment to mental health unveiled in Tuesday’s budget.

Ms Gillard said over $400 million will be spent treating mental health issues in youth, when sufferers are most receptive.

Flanked by former Australian of the Year and mental health expert Patrick McGorry, Ms Gillard chatted with students at a Headspace centre in Melbourne’s west on Friday.

“It’s when people are young that they’re most likely to actually confront some of the most serious mental health conditions,” she said.
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“We understand if you can reach out to the community, if you can have people come into a space where they feel comfortable like this one, if we can have them access services early, that can make a real difference.”

The $419.7 million allocation will be spent over five years to triple the number of Headspace centres from 30 to 90.

Those centres will be backed by additional Early Psychosis Prevention and Intervention Centres, which provide more intensive treatment.

Professor McGorry, who pioneered the Headspace concept, said the funding was a huge boost to a “missing stream of care in the health system”.

He said young people suffering mental health issues can heal with timely treatment, and he called the plan the “antidote” to the failed institutionalisation system.

“(This funding) is going to strengthen our country because it’s going to mean that young people can rightfully take their place in the workforce,” Prof McGorry said.

“The big thing about mental health is that it does strike people in the most productive years of life and we’ve just accepted that until recently.”

Prof McGorry said the challenge for the private board of Headspace was to ensure the funds were spent effectively.

“These are precious dollars, as the prime minister said, they’ve been hard won, we’ve got to make sure the implementation stage is done right,” he said.

Headspace acts as a first point of contact for youth, and can provide counselling and referral services.

Labor’s Mental Health Minister Mark Butler confirmed $580 million of the $2.2 billion had been redirected from other mental health announcements.

Mr Butler said the Headspace centres would be set up in areas of need, with communities able to apply to the Headspace board.

No answer yet on mental health recommendations

The province released its official response to Judge Anne Derrick’s report on the death of Howard Hyde on Thursday.

But neither the minister of justice nor the minister of health could say how many of Derrick’s recommendations will be accepted.

Instead, the 50-page document, billed as Building Bridges, breaks up the 80 recommendations made by Derrick in December into five thematic thrusts.

Those themes — training, collaboration, use of force, supports within the criminal justice system, and mental health services — include “actions,” some already announced and underway.

“We need to be able to reassure people in this province who either have a mental health disorder or are concerned about these issues,” Health Minister Maureen MacDonald said at a press conference.

“The purpose of this response is designed to put in place, fill gaps, services, better training, better communication, better collaboration between (the departments of health and justice).”

How that collaboration will look will largely have to wait until the province releases its mental health and addictions strategy this fall.

Until then, there are few details, including any new investments available.

Stephen Ayer, executive director of the Schizophrenia Society of Nova Scotia, called the response an “excellent first step.”

“There’s a lot of work to be done yet, particularly the development of a mental health strategy for Nova Scotia,” said Ayer.

“We are waiting for that, and obviously, that’s going to be an important document in terms of how they’re going to move forward in terms of resourcing additional funds for mental health.”

Macarthur mental health groups welcome Federal Budget’s $2.2 billion

MACARTHUR mental health support group Beautiful Minds has applauded the $2.2 billion five-year mental health package announced as part of the Federal Budget last Tuesday.

Beautiful Minds founder Sandra McDonald congratulated the government on its investment but questioned how much funding would be poured into the Macarthur region.

“Mental health is such an under-funded area so to get an extra $1.5 billion will help address this serious lack of funding in our health system,” she said.

“People with mental illness need to be treated fairly so it’s great to see this funding coming through but I want to know how much of that will flow through to the Macarthur region.”

Mrs McDonald said staffing of mental health facilities was a big issue which needed to be addressed with the new funding. She said the Campbelltown Community Mental Health Centre had 60 staff catering to 2000 clients.

“We have such a need out here for that funding and I’d like to see additional staffing out here to help deal with mental health issues,” Mrs McDonald said.

City mental health clinic in default on bank loans

One of Baltimore’s largest providers of drug treatment services is in default on loans of up to $2.5 million, its bank says, raising questions about the financial well-being of a clinic that treats hundreds of addicts in the city.

Bank of America is suing Baltimore Behavioral Health Inc. for access to its financial records, alleging that the West Pratt Street clinic is in default and has refused to provide “critical financial information.” The bank also claims that clinic funds paid for board members’ monthly spa services, boat repairs and personal mortgage payments, an accusation that one BBH board member dismissed as unsupported “hype.”

The bank’s lawsuit, filed April 29 in Baltimore Circuit Court, is the latest in a string of recent challenges for BBH. Its revenue has dropped sharply since late 2009, when state mental health officials clamped down on its ability to bill for high-cost treatment, leading to layoffs and prompting the clinic to seek a buyer for its campus.

In late December, the U.S. Department of Labor opened an inquiry into BBH’s employee retirement plan after former workers said money deducted from their paychecks as far back as 2009 never reached their retirement plan accounts. A department spokesman this week declined to comment.

BBH, a private clinic that has received $65 million in government payments over the past five years, specializes in treating patients with both mental illness and drug addiction, mostly billing the Medicaid program for the poor and disabled. It says it treats 150 people a day, down from 225 a year ago.

The clinic was the subject of a Baltimore Sun investigation last year that revealed unusually high Medicaid billings and detailed the nonprofit organization’s control by several family members earning six-figure salaries.

Terry T. Brown, a BBH vice president, said the clinic remains committed to treating patients at its Southwest Baltimore campus. To raise needed cash, BBH hopes to sell its buildings and then lease back some space, he said. The adjacent B&O Railroad Museum has shown interest in buying the property.

“I’m hoping we’re viable to withstand the changes in our economic situation,” Brown said.

Bank of America says it is demanding access to the clinic’s books to conduct an audit. It claims the clinic has denied bank officials their contractual right to review those financial records for the past nine months.

Healthy Nutrition News

Lavaca School Honored In National Health Challenge

Lavaca Elementary School is the only Arkansas school to receive an award in the U.S. Department of Agriculture’s HealthierUS Challenge, the Lavaca School District learned last week.

According to an email from Wanda Shockey, Arkansas Department of Education child nutrition director, to Lavaca school officials, the school is the first in the state to be so honored. The elementary received the USDA program’s Bronze Award.

Only 958 of the nation’s 93,000 schools have received a Bronze, Silver or Gold award, Shockey wrote. In this round, 252 schools from 17 states received awards. Lavaca will receive $500, a plaque and a large banner from the USDA.

The HealthierUS School Challenge is a voluntary national certification program that recognizes excellence in nutrition and physical activity, according to the USDA. A key component of first lady Michelle Obama’s Let’s Move! Initiative to raise healthier children, the HealthierUS program is designed to bring schools closer to compliance with the Dietary Guidelines for Americans and the Institute of Medicine’s recommendations for school meals and foods.

“It’s kind of cool. … We work hard here, we really do,” Lavaca Superintendent Jared Cleveland said Friday.

The USDA award and certification though May 2015 is not the first recognition the district has received in recent months for its healthy practices.

In December, the Lavaca School Board was among six chosen statewide to receive the annual Arkansas Healthy School Board Award from the Arkansas Coordinated School Health Initiative.

Anne Sneed, Lavaca’s special projects coordinator, said the board was recognized for implementing wellness policies, health services, physical education programs, health education curriculum, nutrition/food services, staff/faculty wellness, tobacco prevention/cessation and staff training. Lavaca School Board advocacy led to:

◗ Restructuring the food-service program to include use of whole grains, low-fat milk and additional fresh vegetables. It resulted in an 8.64 percent increase in the district’s meal participation rate.

◗ Implementing the kindergarten through 12th-grade SPARK physical education curriculum, which engages students in structured activities during their PE classes. The school is designated as a SPARKPE Showcase School for the southeast region of the country.

◗ Implementing a water-only vending policy.

◗ Working to host a school-based wellness center at Lavaca Middle School. The wellness center addresses physical and mental well-being of students and also serves as a clinic for community and staff.

The Lavaca Wellness Center opened Jan. 3. Funded through a $175,000 Coordinated School Health and Wellness Center Initiative grant, its health services include eye and ear exams.

“We need to try to change learning conditions,” Cleveland said, noting that learning conditions differ at school and at home.

“My thing is you can truly interweave parental and school involvement. To encourage that, we try to instill healthy habits in students, … and kids in turn teach their parents,” he said.

The district’s Wellness Center provides the school a means to monitor and maintain students’ health. Healthy folks are happier folks, and healthy children learn better, Cleveland said.

Parents become involved because they care about their children’s health, he said.

“If we’re going to be the heart of the community, we want to be a healthy heart,” Cleveland said.

Cleveland credited Lavaca Child Nutrition Director Glynieta Price and her for the concept and development of the district’s healthy nutrition program.

Shockey said ADE’s Child Nutrition Unit worked with Price and her staff to modify menus to meet the HealthierUS requirements.

Cleveland said although only the elementary received the award, the healthy nutrition changes are district-wide. The entire district is being considered for an award at the Silver or Gold level, he said.

“We want the highest-quality food. Food that looks and smells and tastes good and that kids enjoy,” the superintendent said.

Changes include simple acts like moving to whole wheat bread, and more complicated changes like cooking from scratch, he said.

The changes also included changing the cafeteria’s environment to encourage socialization. Music plays in there now, and the students are encouraged to talk to one another.

The changes cost the district “just a hair more,” but it’s not trying to make money from its food program. Being budget-neutral is the goal, Cleveland said.

“We’re just trying, and it’s so nice to be recognized for our efforts, but we’d do it anyway because it’s for the kids,” Cleveland said.

Three Oklahoma schools were recognized in June 2009 with Gold HealthierUS awards – all of them from the Shawnee School District in Pottawatomie County just east of Oklahoma City. Their certification expires this month, according to the USDA.

The Indian food & beverage ingredients sector has been witnessing steady change. Rising awareness has shifted the focus of the industry to health from taste

Life of an average consumer today is changing constantly. Lifestyles are becoming fast paced and oriented towards convenience and solutions on- the- go. People are more aware of the interplay between the food they eat and the role it plays in maintaining a healthy lifestyle. Armed with this self- knowledge, consumers are increasingly seeking food and beverages that enhance their health.

Further rapid improvement in f&b safety & quality norms is also pushing the food processors to think about healthy ingredients for their produce. On other hand industry is tackling to meet these demands with new product innovations, technologies and healthier food ingredients.

Mohan Gantra, managing director for Cloud 9, Goldwin Healthcare Pvt. Ltd, said, “In 2007-08, the health beverage segment in India had registered 50% growth rate with a market size of over Rs 500 crore. With this significant growth rate the Indian health segment would touch Rs 1,100 crore by 2012. The national market is gradually learning the world class trends of healthy eating. Little more time is required for the market to understand.”

“To make our Cloud 9 drink healthier we use natural energy boosters like Guarana, Ginseng Taurine, Pomegranate and “B” group vitamins which help keep your health in check. Gaurana is a rich natural source of caffeine which acts as a stimulant and increases mental alertness, stamina and physical endurance besides fighting fatigue. Ginseng builds mental and physical vitality and strengthens immunity, whereas Taurine work as a metabolic transmitter and also has a detoxifying effect and strengthens cardiac contractility. Pomegranate is a rich antioxidant which prevents free radicals from doing their damage and regulates oxidative stress. Pomegranate juice tends to act as an inhibitor on enzymes responsible for damaging cartilage.” Gantra said.

According to Frost & Sullivan, the global market for food ingredients was estimated to be worth roughly $25bn in 2007, and was expected to touch $30bn by 2010, demonstrating a growth rate for the market of 5-6% year on year. The Indian market has a low base when compared with the global market and was valued at $470m-475m for the year 2007, which is a meager 1.6% of the global market.

Says, Aditi Basu, senior consulting analyst for the chemicals, materials and foods practice, South Asia and Middle East for Frost & Sullivan, “Despite a low base, the scope of growth in the Indian food ingredients market is huge, given the current market size for processed foods in India, which stood at $72bn-75bn for the full year 2007-2008 and has been growing consistently at the rate of 9% year on year. The Indian food processing market is the fifth-largest market in the country and is a “sunrise sector” in India after IT. Further, growing urbanisation, changing lifestyles and the need for convenient healthy foods have ushered in a new category of functional and health foods that claim to be fortified with certain new-age health ingredients offering functional health benefits over and above the basic nutritional value of the foodstuff.”

“Today, India has become homeland for many fatal diseases like diabetes and asthma. Soya protein has been found to have a number of health benefits such as reducing the risk of heart diseases, cancer and osteoporosis, alleviating menopause problems and managing diabetes. Using soyabean as a key food ingredient will improve the nutritional status of children with a positive impact on anthropometrics and cognitive characteristics. The current health awareness will help persuade the masses to accept soyabean and its product in their daily diet,” Ricky Thaper, former consultant at the American Soyabean Association – International Marketing (ASA – IM) told F&B News.

Leading Players
Frost & Sullivan research says that there are over 50 significant market players in the Indian food ingredients market, including globally prominent ingredient companies, such as Danish group Danisco, Dutch group DSM, US group The Solae Company and Germany’s BASF, which have an entire portfolio of ingredient types. Big players have already established their presence in India. These companies operate out of their subsidiary offices in India. For most of the ingredient types, the market is fairly concentrated, with the leading players occupying nearly 60-70% of the market.

In India, food and beverage giants such as PepsiCo, Coca Cola, and Kellogg’s are drastically shifting their product portfolio to more nutritious and healthy products. Even Nestle India, a subsidiary of Nestle, is set to compete with other giants in the health foods category.

Currently, the key ingredients in the Indian market are food colours, flavours, sweeteners, antioxidants and antimicrobials, emulsifier and stabilizers. Their use in the processed food and beverage sector is indispensable. There are also a huge range of special ingredients like probiotics, prebiotics and bio-enzymes.

In addition, there are bulk ingredients like dairy, oils, fats, sugars, basic proteins, emulsifiers, acidulants, phytochemicals, sweeteners, flavours, colours, enzymes, meat seasonings, bakery mixes, fruit preps, vitamin/mineral pre mixes, etc. Other leading companies in the space are Grifith Labs, Pristine Organics, Cargill Flavours, AB Mauri, Sonarome ITC Colors and Phytotec Extracts to name a few.

Future Outlook
According to Frost & Sullivan and Confederation of Indian Food Trade and Industry (CIFTI), food wing of the Federation of Indian Chambers of Commerce and Industry (FICCI), the market is brimming with innovative products and is set to drive growth. There are scores of opportunities for novel product development and the growing demand for convenience foods is giving the segment a further fillip.

According to a report, consumers are expected to increase their spending on packaged foods by 56.5% per capita to $18billion by 2012. The market holds enormous growth potential for snack food, which is estimated to be worth $ 3 billion and growing at a rate of 8-20% annually. Juices and carbonated drinks are also high growth segment at 25% per year. The dairy industry, already the biggest in the world, is forecast to cross $108 billion in revenues by 2011. This will only see significant opportunities for the food ingredients market.

In addition to the growing middle class in India, urbanization, changing lifestyles and the need for convenient healthy foods is pushing the growth of the food ingredients market. As consumers evolve from a subsistence living, they invariably spend a large portion of their new income on food and as a result, they demand healthier food and beverage options. There is a catch though. Generating more income does not mean they are willing to sacrifice convenience. Consumers want healthier products but are unwilling to go out of their way to get it. This means that food and beverage manufacturers need to get creative. To offer nutrition at a convenience is one of the major reasons foods and beverage fortification is so important right now.

“Globally, food ingredients is a multibillion dollar industry and is fast expanding. Innovation in the food and beverage market, especially in the processed food domain, has created innumerable opportunities for new product development in the ingredients market as well,” Aditi Basu added.

The food ingredients sector is indicating ample prospects for growth. The segment is an obligatory factor for the growth of the food and beverage sector which is registering an annual growth rate of 14-16 %. Further the importance of healthy ingredients like soya isolate, whey protein concentrate, dietary fibres and Omega 3 fatty acids among others cannot be ignored. These ingredients are also driving the development of the wellness/ health foods industry to clock 20% growth annually.

5 healthy foods on the cheap

Grocery prices are going up, and the biggest increases sometimes seem to be for the healthier items. But you don’t have to sacrifice health for your budget. Here are five items that will feed your family inexpensively:

† Eggs: For 13 to 18 cents per egg, they pack a lot of nutrition, vitamin D and lean protein.

† Kale: At less than $1 a pound, kale is considered a super green nutritionally.

† Whole-grain pasta: For 10 cents to 40 cents per serving, this is a great source of fiber, which will fill you up.

† Apples: If you buy them bagged, each apple will cost roughly 40 cents.

† String cheese: The individual stick runs 18 to 35 cents per serving, is portable and contains calcium.

Gout Treatment News

Savient Pharma 1Q loss widens on costs

Shares of Savient Pharmaceuticals Inc. slid Thursday after the company posted a wider quarterly loss that missed estimates, prompting an analyst to downgrade the stock.

Savient said its first-quarter loss widened on higher costs as the drugmaker prepared for the launch of its gout treatment Krystexxa.

The company lost $13.5 million, or 19 cents per share, compared with a loss of $8.3 million, or 13 cents per share, during the same period a year prior. Revenue rose 18 percent to $1.3 million from $1.1 million.

Analysts polled by FactSet expected a loss off 30 cents per share on $1.9 million in revenue.

The company reported $300,000 in revenue from Krystexxa. The company’s other drug is Oxandrin, which is used for weight gain following involuntary weight loss.

Operating costs jumped 81 percent to $20.8 million, mainly related to the launch of Krystexxa. In March, the company launched the drug, which is a treatment for adult patients with a type of chronic gout that doesn’t respond well to conventional therapy.

Shares of the company fell $2.04, or 18.4 percent, to $9.04 in afternoon trading and earlier traded at $8.77, its lowest point in 52 weeks. The stock has traded as high as $23.46 over the last year.

Leerink Swann Research analyst Joseph Schwartz downgraded shares to “Underperform” from “Market Perform” and lowered his price target to $4 from $9, saying the company may have overestimated the demand for Krystexxa.

He said the market opportunity for the drug in the U.S. is likely up to 60,000 patients instead of the hundreds of thousands the company expects. He lowered his annual sales estimate for the drug to $350 million from $500 million.

Regeneron Reports First Quarter 2011 Financial and Operating Results

VEGF Trap-Eye is a fusion protein locally administered in the eye that is designed to bind Vascular Endothelial Growth Factor-A (VEGF-A) and Placental Growth Factor (PlGF), proteins that are involved in the abnormal growth of new blood vessels. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States. Bayer HealthCare LLC has rights to market VEGF Trap-Eye outside the U.S., where the companies will share equally in profits from any future sales of VEGF Trap-Eye.

In February 2011, Regeneron submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). In April 2011, the FDA accepted the BLA for filing and granted the Company’s request for Priority Review. Under Priority Review, the target date for an FDA decision on the VEGF Trap-Eye BLA is August 20, 2011.

Also in February 2011, data from the Phase 3 VIEW 1 and VIEW 2 trials of VEGF Trap-Eye in patients with wet AMD and the Phase 3 COPERNICUS trial in macular edema due to central retinal vein occlusion (CRVO) were presented at the Bascom Palmer Eye Institute’s Angiogenesis, Exudation and Degeneration 2011 meeting. Results of the Phase 2 DA VINCI trial of VEGF Trap-Eye in diabetic macular edema (DME) were also presented.

In April 2011, Regeneron and Bayer HealthCare announced positive top-line results for VEGF Trap-Eye in the Phase 3 GALILEO study in patients with macular edema due to CRVO. The positive results from the GALILEO study confirmed the results of the similarly designed COPERNICUS study that were announced in December 2010. In GALILEO, the primary endpoint at week 24 was achieved: 60.2% of patients receiving 2 milligrams (mg) of VEGF Trap-Eye monthly gained at least 15 letters of vision from baseline, compared to 22.1% of patients receiving sham injections (p<0.0001). The key secondary endpoint of the study was also met: patients receiving 2 mg of VEGF Trap-Eye monthly gained, on average, 18 letters of vision compared to a mean gain of 3.3 letters with sham injections (p<0.0001). As in the COPERNICUS trial, VEGF Trap-Eye was generally well tolerated in the GALILEO study and the most common adverse events were those typically associated with intravitreal injections or the underlying disease. Serious ocular adverse events in the VEGF Trap-Eye group were 2.9% and were more frequent in the control group (8.8%). The most frequently reported adverse events overall in the VEGF Trap-Eye arm were eye pain, conjunctival hemorrhage, and elevated intraocular pressure. The most frequently reported adverse events in the control group were macular edema, eye irritation, and reduction of visual acuity. Detailed results of the GALILEO study will be presented at the EURETINA Congress in London in May 2011.

Based on these positive results, Regeneron intends to submit a regulatory application for marketing approval for VEGF Trap-Eye in CRVO in the U.S. in the second half of 2011, and Bayer HealthCare is planning to submit regulatory applications in Europe in 2012.

In April 2011, Regeneron and Bayer Healthcare announced that Bayer HealthCare has initiated the Phase 3 VIVID-DME study of VEGF Trap-Eye in DME in Australia. The trial will also be conducted in Europe and Japan. Regeneron intends to commence a second Phase 3 study (VISTA-DME) in DME later in 2011 in the U.S., Canada, and other countries.

ZALTRAP™ (aflibercept) – Oncology

ZALTRAP™, also known as VEGF Trap, is a fusion protein that is designed to bind VEGF-A, VEGF-B, and PlGF, proteins that are involved in the abnormal growth of new blood vessels in solid tumors. ZALTRAP™ is being developed worldwide by Regeneron and its collaborator, the sanofi-aventis Group, for the potential treatment of solid tumors.

In April 2011, Regeneron and sanofi-aventis announced that the Phase 3 VELOUR trial evaluating ZALTRAP™ in combination with the FOLFIRI chemotherapy regimen [folinic acid (leucovorin), 5-fluorouracil, and irinotecan] versus a regimen of FOLFIRI plus placebo met its primary endpoint of improving overall survival (OS) in the second-line treatment of metastatic colorectal cancer (mCRC). Full results will be presented at an upcoming medical meeting. The most frequent adverse events reported with ZALTRAP™ in combination with FOLFIRI were diarrhea, asthenia/fatigue, stomatitis and ulceration, nausea, infection, hypertension, gastrointestinal and abdominal pains, vomiting, decreased appetite, decreased weight, epistaxis, alopecia, and dysphonia.

Based upon these positive findings, Regeneron and sanofi-aventis plan to submit regulatory applications for marketing approval of ZALTRAP™ for the second-line treatment of mCRC to the FDA and the European Medicines Agency in the second half of 2011.

In February 2011, Regeneron and sanofi-aventis announced results from the Phase 3 VITAL trial evaluating ZALTRAP™ for the second-line treatment of non-small cell lung cancer (NSCLC). The data showed that adding ZALTRAP™ to the chemotherapy drug docetaxel did not meet the pre-specified criteria for the primary endpoint of improvement in overall survival compared with a regimen of docetaxel plus placebo (HR=1.01, CI: 0.868 to 1.174). The addition of ZALTRAP™ to docetaxel demonstrated activity as measured by key secondary endpoints of the study: progression free survival (PFS) (HR=0.82, CI: 0.716 to 0.937) and an overall objective response rate (ORR) of 23.3% in the ZALTRAP™ arm compared to 8.9% in the placebo arm. The types and frequencies of adverse events reported in the ZALTRAP™ treatment arm were generally consistent with those reported in previous studies with anti-VEGF agents. The most frequent Grade 3/4 adverse events included fatigue, stomatitis, disease progression, and hypertension.

Another randomized, double-blind Phase 3 trial (VENICE), which is fully enrolled, is evaluating ZALTRAP™ as a first-line treatment for metastatic, castration-resistant prostate cancer in combination with docetaxel/prednisone. Based on projected event rates, an interim analysis of the VENICE study is expected to be conducted by an Independent Data Monitoring Committee in mid-2011, and final results are anticipated in 2012.

In addition, a randomized Phase 2 study (AFFIRM) is evaluating ZALTRAP™ as a first-line treatment for metastatic colorectal cancer in combination with FOLFOX (folinic acid [leucovorin], 5-fluorouracil, and oxaliplatin). The AFFIRM study is fully enrolled, and initial data are anticipated in the second half of 2011.

ARCALYST® (rilonacept) – Gout

ARCALYST® is a fusion protein that blocks the cytokine interleukin-1 (IL-1). ARCALYST® is currently available for prescription in the U.S. for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. CAPS is a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue.

In February 2011, Regeneron reported the results of its second and third Phase 3 studies of ARCALYST® in the prevention of gout flares in patients initiating uric acid-lowering therapy and announced that, based on these studies and a previously reported Phase 3 study, the Company plans to submit a supplemental BLA for U.S. regulatory approval of ARCALYST® in this setting in mid-2011. The Company reported that in the PRE-SURGE 2 efficacy study in gout patients initiating allopurinol therapy, ARCALYST® met the primary and all secondary study endpoints. The primary endpoint was the number of gout flares per patient over the 16-week treatment period. Patients who received ARCALYST® at a weekly, self-administered, subcutaneous dose of either 160 mg or 80 mg had a 72% decrease in mean number of gout flares compared to the placebo group (p<0.0001). These results were consistent with those in the identical Phase 3 efficacy study (PRE-SURGE 1) reported in June 2010. ARCALYST® was generally well tolerated with no reported drug-related serious adverse events. The most frequently reported adverse event was upper respiratory tract infection (15.5% with ARCALYST® 160 mg, 12.2% with ARCALYST® 80 mg, and 12.2% with placebo).

Regeneron also announced that in the third Phase 3 study (RE-SURGE), which evaluated the safety of ARCALYST® versus placebo over 16 weeks, ARCALYST® was generally well tolerated, and the safety profile was consistent with that reported in the PRE-SURGE 1 and PRE-SURGE 2 studies. RE-SURGE evaluated 1,315 patients who were at risk for gout flares while initiating or taking uric acid-lowering drug treatment. Other than injection site reactions, the incidence of treatment-emergent adverse events was generally well-balanced among the 985 patients who received ARCALYST® at a weekly, self-administered, subcutaneous dose of 160 mg and the 330 patients who received placebo. Injection site reactions, usually considered mild, were reported more commonly with ARCALYST® (15.2%) than with placebo (3.3%). Overall, the cumulative rate of infections was 20.1% in patients treated with ARCALYST® and 19.1% in placebo patients. Serious infections were reported in 0.5% of patients treated with ARCALYST® and 0.9% of placebo patients. Deaths were reported for 0.3% of patients treated with ARCALYST® and 0.9% of placebo patients.

In the RE-SURGE study, ARCALYST® also met all secondary endpoints, which evaluated efficacy, over the 16 week treatment period (p<0.0001). These included the number of gout flares per patient, the proportion of patients who experienced two or more flares, and the proportion of patients who experienced at least one gout flare during the study period.

Regeneron owns worldwide rights to ARCALYST®.

Monoclonal Antibodies

Since 2007, Regeneron and sanofi-aventis have collaborated on the discovery, development, and commercialization of fully human monoclonal antibodies generated by Regeneron using its VelocImmune® technology. During the fourth quarter of 2009, Regeneron and sanofi-aventis expanded and extended their collaboration with the objective to advance an average of four to five antibodies into clinical development each year between 2010 and 2017. The following eight antibody candidates are currently in clinical development under the collaboration:

REGN727, an antibody to Proprotein Convertase Substilisin/Kexin type 9 (PCSK9), a novel target for LDL cholesterol (“bad cholesterol”) reduction, has been evaluated in Phase 1 studies using both intravenous and subcutaneous routes of administration. REGN727 is being studied as a single agent and in combination with statin therapy. Phase 2 studies have been initiated in combination with statins in patients with hypercholesterolemia.

REGN88, an antibody to the interleukin-6 receptor (IL-6R), is in a Phase 2/3 study in rheumatoid arthritis and a Phase 2 study in ankylosing spondylitis, a form of arthritis that primarily affects the spine. Both studies are enrolling patients, and initial Phase 2 results are expected in mid-2011.

REGN421, an antibody to Delta-like ligand-4 (Dll4), a novel angiogenesis target, is in a Phase 1 study in patients with advanced malignancies.

REGN668, an antibody to the interleukin-4 receptor (IL-4R), a target for allergic and immune conditions, has completed Phase 1 testing in healthy volunteers. A Phase 1b study in patients with atopic dermatitis and a Phase 2 study in eosinophilic asthma are underway.

REGN910, an antibody to angiopoietin-2 (ANG2), a novel angiogenesis target, is in a Phase 1 study in an oncology setting.

REGN475, an antibody to nerve growth factor (NGF), has completed a Phase 2 trial in osteoarthritis of the knee. In December 2010, the Company was informed by the FDA that a case confirmed as avascular necrosis of a joint was seen in another company’s anti-NGF program. The FDA believes this case, which follows previously-reported cases of joint replacements in patients on an anti-NGF drug candidate being developed by another pharmaceutical company, provides evidence to suggest a class-effect and has placed REGN475 on clinical hold. There are currently no ongoing trials with REGN475 that are either enrolling or treating patients.

REGN728 and REGN846, whose targets remain undisclosed, have entered clinical development.

Financial Results

The Company’s total revenues increased to $112.2 million in the first quarter of 2011 from $103.5 million in the same quarter of 2010. The increases were primarily due to higher collaboration revenue in the first quarter of 2011 in connection with the Company’s antibody collaboration with sanofi-aventis.

Net product sales of ARCALYST® in the first quarter of 2011 were $4.4 million. Net product sales of ARCALYST® in the first quarter of 2010 were $9.9 million, which included $5.1 million of net product sales made during the quarter and $4.8 million of previously deferred net product sales.

The Company’s total operating expenses increased to $153.2 million in the first quarter of 2011 from $132.4 million in the same quarter of 2010. The increases were primarily due to higher research and development expenses arising from the Company’s expanding research and development activities in 2011 and related higher employee headcount, principally in connection with the sanofi-aventis antibody collaboration. Research and development expenses in the first quarter of 2011 rose to $129.4 million from $117.5 million in the same quarter of 2010.

The Company had a net loss of $43.4 million, or $0.49 per share (basic and diluted), for the first quarter of 2011 compared with a net loss of $30.5 million, or $0.38 per share (basic and diluted), for the first quarter of 2010.

At March 31, 2011, cash and marketable securities totaled $607.6 million (including $7.5 million of restricted cash and marketable securities) compared with $626.9 million (including $7.5 million of restricted cash and marketable securities) at December 31, 2010.

About Regeneron Pharmaceuticals

Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration, central retinal vein occlusion, and diabetic macular edema), and certain cancers. Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information about Regeneron and recent news releases are available on Regeneron’s web site at www.regeneron.com.

This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future financial performance of Regeneron, and actual events or results may differ materially from these forward-looking statements. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron’s product candidates and research and clinical programs now underway or planned, the likelihood and timing of possible regulatory approval and commercial launch of Regeneron’s late-stage product candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize its product and drug candidates, competing drugs that may be superior to Regeneron’s product and drug candidates, uncertainty of market acceptance of Regeneron’s product and drug candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any license or collaboration agreement, including Regeneron’s agreements with the sanofi-aventis Group and Bayer HealthCare, to be canceled or terminated without any product success, and risks associated with third party intellectual property and pending or future litigation relating thereto. A more complete description of these and other material risks can be found in Regeneron’s filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2010 and Form 10-Q for the quarter ended March 31, 2011. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise, unless required by law.

Savient Pharmaceuticals (SVNT) Finally Sells Kyrstexxa and Stops Auctioning Itself Off

Shares of small cap biotech Savient Pharmaceuticals (SVNT: Charts, News, Offers) have been trading near the lower end of its 52-week range of $9.06 to $23.46 despite the blockbuster potential of its chronic gout treatment, Kyrstexxa. Kyrstexxa is the first new gout treatment in four decades and a vast improvement over existing medications, treating a previously untreatable disease, and was approved by the FDA last year. The FDA granted Kyrstexxa an orphan status, which means that Savient’s drug will enjoy seven years of marketing exclusivity, being untouchable by biotech competitors and generic drug makers. This should be fantastic news for investors – stocks such as InterMune ITMN have skyrocketed overnight on similar prospects of locking up the market with an exclusive drug. InterMune shares in particular have more than tripled in five months on news that its exclusive idiopathic pulmonary fibrosis drug Esbriet had been approved by the European Union. So why has the market continuously punished Savient? Should new investors with a longer time frame with higher risk tolerance pick up shares in expectation of high sales of Kyrstexxa, or is something rotten under the company’s shiny surface?

Something is indeed rotten – Savient’s management. Immediately after receiving FDA approval for Kyrstexxa, the management team attempted to auction the company off to the highest bidder, which caused investors to lose confidence in the company and dump shares. At the time, Savient believed that it didn’t have the capital to develop a sales and marketing team, and would incur losses which would be better spent on research and development for new products. Therefore, the company’s management believed that a big pharmaceutical company – such as Novartis AG (NVS: Charts, News, Offers), Pfizer (PFE: Charts, News, Offers) or Merck (MRK: Charts, News, Offers) would be better equipped to market Kyrstexxa, and they expected these big buyers to pay a high premium on the stock price to acquire its drug.

However, the big fish didn’t bite, and the management didn’t profit – they only sunk their own stock – crashing from above $23 to $9 after its last attempt to auction itself off failed. Shares of Savient had been trading near $15 prior to FDA approval, which may lead value investors to point out that its current share price at $11 is irrational. However, at $11 the stock still trades at a massive 15.6 times book value, compared to an industry price to book ratio of 3.2, meaning that the company simply doesn’t have the cash or earnings per share to back up its share price, with considerable downside risk. However, Savient still has a drug which is attractive to either large pharmaceuticals or a generic drug maker such as Teva Pharmaceuticals (TEVA: Charts, News, Offers), and the purchase of the company seems inevitable. However, with a series of failed auctions, buyers may be waiting for Savient’s stock price to collapse before swooping in to pick up the company at a steep discount.

The company has since launched its Kyrstexxa by itself, spending capital training a sales force in January and hiring former ImClone Systems CEO John Johnson to oversee operations. Analysts believe that Kyrstexxa could bring in sales of $600 million in the United States along for the first quarter of 2011, which is based on approximately 10,000 patients being administered the drug. Beyond the current quarter, analysts forecast that the number of patients using Kyrstexxa could increase to 45,000-56,000, which could bring in approximately $3 billion in the future. In the United States alone, approximately 100,000 of 2 million gout patients suffer from severe refractory gout, an estimate which Savient claims is closer to 170,000, which would be in critical need of Kyrstexxa. Investors, analysts and potential buyers are watching Savient’s earnings report on May 5 in expectations of revenue between $2 to $3 million which would signal that demand for Kyrstexxa is healthy and growing. Anything under that may cause shares to crash further, as the company becomes even less attractive to large pharmaceutical companies.

Cancer News and Treatment

Researchers find new lung cancer treatment

RESEARCHERS looking for better ways to treat tumours in children say they may have stumbled instead on something even better – a new therapy for lung cancer, Australia’s single biggest cancer killer.

Lung cancer is the fifth-most commonly diagnosed cancer in this country, accounting for 9703 diagnoses in 2007 – fewer than half the 19,403 new prostate cancer cases recorded the same year.

It also lags well behind bowel cancer (14,234 cases), breast cancer (12,670) and melanoma (10,342).

But lung cancer remains far and away the single most deadly cancer, claiming 7626 lives in 2007 – nearly double the number of the next-biggest, bowel cancer (4047).

Part of the reason lung cancer remains so deadly is that it is often detected relatively late, and is often difficult if not impossible to remove surgically.

But scientists at the Children’s Cancer Institute Australia, in Sydney, have found a new approach that promises to tackle another reason why the prognosis for most patients with lung cancer can be so poor: the tendency for their tumours to resist chemotherapy drugs.

Maria Kavallaris, the head of the CCIA’s tumour biology and targeting program, and a former president of the Australian Society for Medical Research, said her team used a “gene-silencing” approach to knock out the gene in the cancer cells that made them resistant to the effects of chemotherapy.

The findings, presented at the Australasian Gene Therapy Society meeting in Melbourne yesterday, have so far been tested successfully in mice, and Professor Kavallaris said she hoped human trials would begin next year.

“When we switch off this gene, and treat the cancer cells with the chemotherapy that they weren’t responding to before, then they become responsive,” Professor Kavallaris said.

“It’s still early days, but it’s showing great promise. It’s very encouraging.”

The researchers are still trying to work out how best to deliver the drug to cancer cells in live patients – such as injection, or steady infusion through a drip.

It is hoped the therapy, if successful in later trials, could also prove useful for solid cancers in children, such as neuroblastoma – which is one of the most aggressive childhood cancers.

A new treatment for childhood cancers such as neuroblastoma was what the CCIA team were looking for when they realised their therapy could be of benefit to adult patients as well.

First Wednesday events to support cancer treatment and survivors

It’s time to Paint the Town Purple for First Wednesday this month.

Go Downtown and Relay for Life are working together for the event, which is in its second year. Relay teams will be gathered throughout downtown Salem to raise money for the June 17-18 event, and cancer survivors are encouraged to check in at the survivor’s table at Liberty and Court streets NE.

The highlight of the evening will be the Luminaria Concert, which begins at 7:30 p.m. in the Trinity Ballroom of the Reed Opera House, 189 Liberty St. NE.

The concert will feature some of Oregon’s biggest names in blues and soul, including Norman Sylvester, Garry Meziere, Dave Fleschner, Larry London and Terry Robb. They will play together, but you can hear them individually during the “Battle for the Best — Tunes for Tips” solo competition; vote with your money for the best performance.

During the concert, sponsorships for 11 lap quilts will be auctioned off; there is a suggested $25 starting bid. In turn, the lap quilts will go to people in cancer treatment.

Inside and outside the ballroom will be the paper lanterns called “luminarias,” which will be lighted to honor a survivor or memorialize someone who has died.

The concert is free, but there is a suggested $3 donation. All proceeds will go to Relay for Life.

Elsewhere, Travel Salem (181 High St. NE) will host a wine tasting and reception. At Dave Wilson Designer Goldsmith, 216 Commercial St. NE, Susan Trueblood Stuart will show “Painting My Way Through Cancer,” 21 paintings she made during her struggle with jaw cancer.

Per usual, there are gallery shows, restaurant specials and shop sales.

Nucletron Showcases Five Innovations in Cancer Treatment at ESTRO

Nucletron, a leading provider of state-of-the-art radiotherapy solutions for cancer treatment will feature five new innovations at the ESTRO Anniversary Congress, May 8-11 in London, all designed to meet the growing interest and need to more effectively treat a wide variety of cancers. In addition, as one of the first industry partners with the organization, Nucletron will be celebrating its long collaboration with ESTRO on its 30th anniversary.

“2011 is the Year of Radiotherapy in the UK, and there is no better location than London for ESTRO to hold this year’s meeting and commemorate its 30th anniversary. Nucletron is proud of our long term partnership with ESTRO, and we’re looking forward to working with the organization and its members to further advance the important role of radiotherapy, in particular brachytherapy, in the multimodality treatment of cancer,” said Jos Lamers, CEO of Nucletron. “Our commitment to product innovation, professional education, and raising awareness of the benefits of brachytherapy – all aimed at ensuring patient access to quality cancer care – will highlight Nucletron’s presence at this year’s meeting,” he added.

Nucletron will feature five innovative products and solutions at this year’s meeting, all of which were developed with the needs of the modern radiotherapy department for speed, efficiency, accuracy and quality in mind. Awareness of brachytherapy will also receive special attention, with the presentation of a range of awareness and educational materials.

The Vaginal CT/MR Multi Channel Applicator (VCMC) is the first Precise Dose Delivery Solution (PDDS(TM)) for treating gynecologic cancers. The VCMC features a unique design of multiple channels which are curved in the tip of the applicator, and which can be loaded selectively. This provides accurate precision and dose direction, bringing dosimetry measurably closer to the vaginal wall. The VCMC is easy to assemble, clean & sterilize, thus providing economical treatment and optimized day-to-day utilization. This new addition to Nucletron’s range of innovative applicators allows healthcare providers to tackle more complex or advanced endometrial and other gynecological cancers. The recent PORTEC (Postoperative Radiation Therapy for Endometrial Carcinoma) 2 study highlighted the benefits of vaginal brachytherapy versus external beam radiotherapy, in particular significantly lower toxicity and superior QOL outcomes. Delivering the dose where it is most needed, a key aspect of brachytherapy in sparing healthy tissue and reducing treatment toxicity, makes this unique CT/MR-compatible applicator a logical solution in response to the demands of modern gynecologic radiotherapy.

Nucletron’s Prostate Solutions represent a seamless, all-in-one solution that addresses clinical needs, whether these call for low dose rate (LDR or “seeds”), High Dose Rate (HDR) or both. This all-in-one solution is the only one to cover both HDR & LDR in one software configuration. It combines dynamic treatment planning and delivery with advanced robotic accuracy, thereby improving clinical outcomes in patients undergoing prostate brachytherapy. Built around the latest state-of-the-art Oncentra(R) software, each solution integrates ultrasound technology allowing optimal control over the treatment process. Nucletron’s advanced Robotic Seed Delivery technology guarantees reliable, reproducible and precise treatment. The unique combination of dynamic treatment planning and delivery with advanced robotic accuracy helps health care professionals improve clinical outcomes in patients undergoing prostate brachytherapy.

Nucletron will also be showcasing the latest version of its brachytherapy treatment planning solution Oncentra (R) Brachy. Developed with the needs of the busy radiotherapy department in mind and with a focus on shortening workflows, it combines up to 50% reduction in planning times with exemplary treatment planning accuracy. Key components of Oncentra Brachy 4.0 are library plans and GYN applicator models, the first in a series of applicator models. The ability to automatically reconstruct exact applicator geometry from a 3D library eliminates the uncertainty of individual interpretation and assures placement precision. Furthermore, the new libraries and automatic reconstruction can dramatically reduce the time needed for planning, without compromising on quality. This latest edition of Nucletron’s advanced brachytherapy software also addresses the call for reproducibility, leveraging applicator models and library plans to ensure consistency, be it between fractions or between users.

Nucletron’s commitment to external beam treatment planning will also be very much on show, with two leading edge solutions.

The first, the latest release of Oncentra External Beam, intelligently automates routine planning tasks and increases patient throughput. Speed is very much of the essence with the premier of Oncentra’s GPU technology which dramatically speeds up dose calculation, reducing complex calculation times from hours to minutes for enhanced dose algorithms. Users of Oncentra External Beam 4.0 can now routinely have collapsed cone accuracy, in pencil beam times, and creating a 3D plan can take as little as 15 seconds. Oncentra connects to all treatment delivery systems. Its modular planning environment allows it to be used with a department’s linear accelerator of choice and still benefit from the latest in planning tools and technology offered in this new version.

The second, Velocity, brings the best of modern radiotherapy – multiple modality, dose summation and adaptive planning – directly to the radiotherapy department. This innovative solution allows users to turn the sheer volume of data and complexity of today’s radiotherapy directly to their advantage. A unique range of integration tools provides the ability to combine images from multiple modalities, integrate dose summation regardless of source, and apply adaptive contouring across multiple datasets with both accuracy and speed. Velocity eliminates repetitive and time-consuming segmentation tasks by leveraging proprietary anatomy atlases, significantly decreasing treatment planning time and complexity. This new solution provides the user with the full “patient” picture and the advantage of an accelerated workflow.

To learn more about these new innovations in precision cancer treatment, visit Nucletron during the ESTRO Anniversary Conference at booth 110.

HIV drug could lead to new cervical cancer treatment

The HIV protease inhibitor lopinavir (a component of Kaletra) triggers cells infected with human papillomavirus to produce an antiviral protein, inducing death of the cancerous cells, researchers at the University of Manchester report in the journal Antiviral Therapy.

“We have now found that lopinavir selectively kills HPV-infected, non-cancerous cells, while leaving healthy cells relatively unaffected,” said Dr Ian Hampson, from Manchester’s School of Cancer and Enabling Sciences.

The finding could lead to a new form of treatment for cervical cancer, which is caused by certain high-risk types of human papillomavirus.

At present treatment options for precancerous lesions caused by human papillomavirus, and for cervical cancer, are limited to freezing with liquid nitrogen in early stages, to electrocauterisation, or to surgery and chemotherapy in cases of cervical cancer.

However, in low and middle-income settings surgical treatments for precancerous lesions and for cervical cancer are often more difficult to deliver due to limited screening programmes, a lack of surgically trained staff and lack of medicines. Due in part to these obstacles, cervical cancer is the most common malignancy in women in sub-Saharan Africa.

Treatments which can be delivered easily by nurses and by affected women, starting on the day when a precancerous lesion is identified, could be particularly important in reducing progression to cervical cancer and deaths from cervical cancer in the developing world.

Although HPV vaccination is being introduced in some countries it cannot protect women who have already developed precancerous changes or who have been infected by high-risk HPV types that are not included in the two vaccines now available.

More generally, a drug which is effective against HPV could revolutionise the prevention of anal and oral cancers caused by HPV.

The University of Manchester researchers tested the effect of lopinavir on HPV-infected cells derived from cervical cancer and from human foreskin.

They found that lopinavir increased the production of ribonuclease L in cells infected with cancer-causing HPV types. HPV appears to reduce the expression of ribonuclease L, but the process which HPV reduces Ribonuclease L expression is inhibited by lopinavir.

The authors also speculate that the same process could lower host antiviral defences and so permit infection with other viruses, indicating a possible explanation for the association between HPV infection and subsequent risk of HIV infection in men and in women.

Co-author on the paper, Dr Lynne Hampson, said: “These results are very exciting since they show that the drug not only preferentially kills HPV-infected non-cancerous cells by re-activating known antiviral defence systems, it is also much less toxic to normal non-HPV infected cells.

“Lopinavir is obviously safe for people to take as tablets or liquid but our latest findings provide very strong evidence to support a clinical trial using topical application of this drug to treat HPV infections of the cervix.”

Standard dose Kaletra treatment in women with HIV is unlikely to show an association with a reduced risk of cervical cancer due to the dose needed to kill HPV-infected cells.

Dr Hampson said: “Our results suggest that for this drug to work against HPV it would be necessary to treat virus-infected cells of the cervix with roughly 10-15 times the concentration that is normally found in HIV-infected patients taking lopinavir as tablets. This implies that, for this treatment to work, it would need to be locally applied as a cream or pessary.”

Obesity Today: News and Treatment

Could obesity treatment lower death risk?

Obesity treatment could be needed by people suffering from coronary artery disease who tend to put weight on around their stomach.

According to research from the Mayo Clinic, published in the Journal of the American College of Cardiology, people with belly fat and coronary artery disease are twice as likely to die as those who tend to put on weight elsewhere.

Francisco Lopez-Jimenez, lead investigator of the project, commented: “Visceral fat has been found to be more metabolically active. It produces more changes in cholesterol, blood pressure and blood sugar.

“However, people who have fat mostly in other locations in the body, specifically, the legs and buttocks, don’t show this increased risk.”

The research team looked at data from nearly 16,000 people involved in five studies around the world and confirmed that ‘central obesity’ increased the risk of death.

According to the researchers, physicians should consider counselling coronary artery disease patients with normal body mass indexes to lose weight if they have a large waist circumference or a high waist-to-hip ratio.

Discrimination hurts: Lack of fair treatment leads to obesity issues

People, especially men, who feel any kind of discrimination, are likely to see their waistlines expand, according to research from Purdue University.

“This study found that males who persistently experienced high levels of discrimination during a nine-year period were more likely to see their waist circumference increase by an inch compared to those who did not report discrimination,” said Haslyn E.R. Hunte, an assistant professor of health and kinesiology. “Females who reported similar experiences also saw their waistlines grow by more than half an inch. This shows how discrimination hurts people physically, and it’s a reminder how people’s unfair treatment of others can be very powerful.

“People who feel unfairly treated should be aware of this connection between the stress related to their perception and consider coping strategies like exercise or other healthy behaviours as a coping mechanism for such stress. More importantly, as a society we must become more aware of how we treat people and that treating others unfairly matters beyond hurt feelings.”

These findings are published online in the American Journal of Epidemiology. The study, based on a predominantly white sample of more than 1,400 people, compared health and ageing data from the 1995 and 2004 National Survey of Midlife Development in the United States. Hunte found that people who reported recurring discrimination tended to have a higher increase in waist circumference over time. Men reported an average of 2.39 centimetres increase in waist circumference compared to those who reported low levels of discrimination, and women reported an average increase of 1.88 centimetres over others during the nine-year period.

“While this study shows there is a difference between men and women, it doesn’t provide specific reasons for that difference,” Hunte said. “More research will need to be done to understand how and why men and women cope differently with this stress or if there are differences in how their bodies react.”

Hunte focused on waist circumference – instead of the body mass index formula, which measures obesity based on height and weight –because abdominal fat is a better indicator of poor cardiovascular-related health outcomes than body mass index.

“Being fat is not healthy, but there are greater problems with individuals who are more pear shaped, meaning that fat builds up in their waist region, rather than someone whose fat is deposited throughout the body,” Hunte said. “There is some indication that stressors, such as interpersonal discrimination, can concentrate fat around the midsection. We’re not sure why, and more work needs to be done to understand this connection between behaviour and physiology. How does what’s above the skin affect what is taking place under the skin?”

People who reported ongoing perceptions of discrimination said they were treated with less courtesy than others, received poorer customer service or people acted as if they were afraid of them. The source of discrimination is not known, but Hunte did exempt individuals who reported that they felt discrimination due to their weight.

Hunte is planning to investigate this further by studying biomarkers, such as cortisol, which is a stress-induced hormone, in relationship to effects of discrimination.

Hunte was supported by the Department of Health and Kinesiology and the Robert Wood Johnson Foundation Health and Society Scholars program. The national survey was funded by National Institute of Aging and the John D. Catherine T. MacArthur Foundation Research Network on Successful Midlife Development.

Vivus trims 1st-quarter loss on lower spending

Drug developer Vivus Inc. said Monday that it posted a smaller loss for the first quarter as it spend less on research and development as its drugs neared approval.

Vivus also said it is looking to resubmit its application for approval of obesity drug Qnexa to the Food and Drug Administration in the fourth quarter. The approval is being sought to market Qnexa as a weight-loss treatment for men and women past child-bearing age.

The FDA declined to approve Qnexa in October, and it has asked Vivus to look into the risk of birth defects in women who use topiramate as a migraine treatment. Topiramate is an ingredient in Qnexa. The company met with the FDA earlier this month to discuss performing a retrospective study using existing electronic healthcare databases to assess birth defects in the children of women who were exposed to topiramate during pregnancy. Vivus said it has reached agreement with the FDA on the study’s design, goals and eligibility criteria.

Vivus reported a loss of $9.9 million, or 12 cents a share, for the three months ended March 31. That compares with a loss of $18.8 million, or 23 cents a share, in the prior-year quarter. The results beat analysts’ consensus forecast for a loss of 15 cents a share, according to FactSet.

The company spent $4.5 million on research and development during the quarter, down from $10.2 million in the prior-year period. The sharp decline in spending was due to Vivus’ avanafil project and potential obesity treatment Qnexa each progressing from the clinical trial stage to the approval stage.

Shares of Vivus added 45 cents, or 5.8 percent, to $8.23 in aftermarket trading. The shares rose 3 cents to $7.80 during the regular session.

Needed health care put off because of high cost, UW study shows

The high cost of health care is hurting everyone, with parents forgoing taking their sick kids to the doctor even if they have health insurance and make enough money to cover the cost, according to a new study from researchers at UW-Madison.

A research team from the UW-Madison School of Medicine and Public Health said the cost of health care relative to a family’s income, plus having a child with a limitation such as asthma, autism or obesity, can make families put off needed medical care.

The findings were presented on Sunday at the Pediatric Academic Societies annual meeting in Denver, and were released on Tuesday by the UW-Madison news service.

The research team was headed by doctoral student and graduate research assistant Lauren Wisk.

“Families aren’t choosing to spend their money on going to the doctor when someone is sick because of how much it cost them to see the doctor the last time,” Wisk said in the release. “They are sacrificing their health because it costs too much to be healthy.”

The team looked at data from six years’ worth of surveys on 6,273 families with at least one child.

Excessive financial burden was defined as a family using at least 10 percent of its income on insurance premiums and out-of-pocket health care expenses, and delayed or forgone care was defined as putting off or going without treatment or prescription medication because of the cost.

The study showed families experiencing excessive financial burdens, having a child with an ongoing limitation and a parent with intermittent insurance all increased the chances health care would be delayed or not used.

“Every U.S. family has a finite amount of resources available, and every day decisions have to be made how to allocate those resources,” Wisk said. “This study shows the unfortunate reality of the situation.”

More research is planned to see how delaying or forgoing care affects health down the road.

“We expect that if people aren’t getting the care they need, they will be sicker as a result,” Wisk said.

“When you put this all together, the cost of health care in the U.S. could actually be causing Americans to be sicker.”

Editor’s Commentary – Association of obesity with prostate cancer: A case-control study within the population-based PSA testing phase of the ProtecT study

Obesity is not associated with prostate cancer (CaP), according to a report by Dr. Polyxeni Dimitropoulou and collaborators that appears in the online version of the British Journal of Cancer.

The authors note that obesity is associated with a number of chronic diseases such as coronary artery disease, hypertension and diabetes as well as CaP mortality, but it is not clearly associated with CaP incidence. This is a case-control study nested within the PSA-testing phase of the Prostate testing for cancer and Treatment (ProtecT) study. It evaluates associations of obesity with screening-detected CaP. Obesity was measured by body mass index (BMI), waist circumference and waist-to-hip ratio (WHR).

Patients included in the analysis were age 50-69 years who had PSA testing and a diagnosis of CaP. They were matched for clinicopathologic characteristics with controls. Assessed metrics were both objective and patient-reported. Data was complete for BMI, age and family history for 3,931 controls and 919 cases.

More cases (8.1%) than controls (5.2%) had a family history of CaP. Regarding obesity, in the highest tertiles there were 18.4% cases and 21.5% controls with a BMI ≥30kg m-2. There were 30.5% of cases with >99cm waist circumference compared with 32.1% for controls. WHR was >0.95 in 31.8% of cases and 33.9% of controls. After exclusions for missing data, the number of cases (1,089) and controls (5,020) used in the analysis was similar to the eligible participants not included in the analysis in terms of family history of CaP. However, in terms of age, those included were on average one year older than those not included. Considering BMI, waist measurement and WHR, there was no relationship between any of these three obesity measures and total prostate cancer. Only BMI had a minimally significant relationship to pathological stage or grade.

Dimitropoulou P, Martin RM, Turner EL, Lane JA, Gilbert R, Davis M, Donovan JL, Hamdy FC, Neal DE

Mood Disorders Treatment Today

Demi Lovato Reflects on Time at Timberline Knolls

Tucked away in a secluded woodland area off New Avenue, Timberline Knolls Residential Treatment Facility enjoys a relatively quiet existence, often going completely unnoticed by local residents.

Last November, however, a number of Internet sites reported that the Lemont facility was playing host to a high-profile patient—18-year-old Disney star Demi Lovato.

At the time, Lovato’s representatives said she had left a tour with the Jonas Brothers to receive treatment for “emotional and physical issues she has dealt with for some time.”

Recently, Lovato opened up about her experiences in interviews with People magazine and ABC’s 20/20, admitting she had received treatment at Timberline Knolls for cutting, bulimia and anorexia.

She also learned she was suffering from bipolar disorder, she said.

“I had no idea that I was even bipolar until I went into treatment,” she told Robin Roberts during the 20/20 interview that aired Friday.

From Oct. 30 to Jan. 27, Lovato received intense in-patient treatment at Timberline Knolls, which specializes in the treatment of eating disorders, substance abuse and addiction, and mood disorders in women.

“I worked harder in those three months than I ever did in my life,” Lovato told People. “I basically went through hours of therapy every day. … It was a battle, but I stuck it out.”

Since completing treatment, Lovato continues to work with a therapist nutritionist and sponsor in Los Angeles, People reports. She recently announced she was leaving her Disney Channel show, Sonny With a Chance, to focus on music and her recovery.

“I’ve never been more peaceful or happy in my life,” Lovato said. “What’s important is to help others get to this place.”
Timberline Knolls

Timberline Knolls is a 43-acre facility located in Lemont. It was founded in 2005 by a team of psychiatrists, psychologists and clinicians as an in-patient treatment center for women dealing with trauma, eating disorders and drug addiction.

“Our residents — adult women and adolescent girls — come to us when they need immediate, life-saving and life-changing help,” according to the center’s website. “Our vision is to help residents achieve lifelong recovery by bringing together clinical treatment with spiritual and emotional growth.”

In February, Timberline Knolls observed National Eating Disorders Awareness Week by hosting a number of special programs and guest speakers to “educate the public on eating disorders and body image issues while reducing the stigma surrounding eating disorders and improving access to treatment.”

New guidelines for assessing tic disorders

Clinical guidelines from the European Society for the Study of Tourette Syndrome have emphasised the importance of comorbid psychiatric disorders in assessing patients with Tourette’s and other tic disorders.

“Tic disorders represent a range of tics and co-existing symptoms with a varied and heterogeneous presentation,” the guidelines state.
“In most situations, a standard interview with a few additional questionnaires and rating scales are sufficient to guide diagnosis and treatment.

However, psychiatric comorbidity occurs in more than three-quarters of cases that are referred for specialised care.”

Attention deficit hyperactivity disorder is the most common comorbidity — occurring in up to 60 per cent of childhood and adult cases — followed by obsessive compulsive disorders, anger control problems, sleep disorders, learning disorders, mood disorders, anxiety disorders, and conduct and oppositional-defiant disorders.

Self-report scales can help to provide general information on psychopathology. The Child Behaviour Checklist can be completed by parents, and self-report questionnaires can be completed by adolescents. A range of tic-specific instruments are available, including the Yale Global Tic Severity Scale and the Shapiro Tourette Syndrome Severity Scale.

“The features that distinguish tics from other movement disorders — with the exception of akathisia [restless legs syndrome] and psychogenic movement disorders — are 1) the ability to suppress them for a while, and 2) the patient’s experience of tics as a (partly) voluntary movement to relieve an inner tension or premonitory focal sensory sensation.”

Neuropsychological assessment can be useful because of the high prevalence of learning disorders in children with tics. It can define the problems arising from the underlying disorder, and those resulting from the disruption caused to education.

Diabetes Treatment News

MU researchers pioneer animal diabetes treatment

Studies show the incidence of diabetes in dogs has increased 200 percent over the past 30 years. Now, University of Missouri veterinarians have changed the way veterinarians treat diabetes in animals by adapting a device used to monitor glucose in humans.

Dogs are susceptible to type 1, insulin-dependent diabetes. Affected animals are unable to utilize sugar in their bloodstream because their bodies do not produce enough insulin, a hormone that helps cells turn sugar into energy. Veterinarians treat animals with this type of diabetes similarly to the way humans are treated, with insulin injections and a low-carbohydrate diet.

Amy DeClue, assistant professor of veterinary internal medicine, and Charles Wiedmeyer, assistant professor of veterinary clinical pathology, have been studying the use of a “continuous glucose monitor” (CGM) on animals since 2003. A CGM is a small flexible device that is inserted about an inch into the skin, to constantly monitor glucose concentrations.

“Continuous glucose monitoring is much more effective and accurate than previous glucose monitoring techniques and has revolutionized how veterinarians manage diabetes in dogs,” said DeClue. “The CGM gives us a complete view of what is happening in the animal in their natural setting. For example, it can show us if a pet’s blood glucose changes when an owner gives treats, when the animal exercises or in response to insulin therapy.”

CGMs have become more commonly used in dogs with diabetes that are not responding well to conventional treatment. The monitor provides detailed data for glucose concentrations throughout the course of three days in a dog’s usual environment, so veterinarians can make better treatment decisions. Previously, veterinarians would have created an insulin regimen based on a glucose curve by taking blood from the animal in the veterinary hospital every two hours over the course of a single day. The glucose curve was often inaccurate due to increased stress from the animals being in an unnatural environment.

Dogs show clinical signs of diabetes similar to humans. Clinical signs include increased urination, thirst, hunger and weight loss. Typically, no direct cause is found for diabetes in dogs, but genetic disposition and obesity are thought to play a role in causing diabetes, according to DeClue. Just like people, dogs suffering with diabetes must be medically managed or complications can arise.

“Typically, dogs that are treated properly for diabetes go on to live a long, full life,” said Wiedmeyer.

“Actually, dogs with diabetes are similar to young children with diabetes but somewhat easier to manage. Dogs will eat what their owners give them at the same time each day and they won’t ask for a cupcake at a friend’s birthday party. With tools like the continuous glucose monitor to assist with disease management, the outlook is very good for a dog with diabetes.”

In the future Wiedmeyer projects that the device will become smaller and less invasive. In addition, he hopes device manufacturers develop a device that would monitor blood sugar levels remotely.

DeClue and Wiedmeyer’s most recent article on methods for monitoring and treating diabetes in dogs was published in the journal, Clinic in Laboratory Medicine.

Hospital to pioneer new diabetes treatment

Doctors from Hackensack University Medical Center hope to find a cure for diabetes as they embark on a partnership with one of the world’s leading researchers for the disease.

The hospital will be the first to try a procedure on humans with diabetes that is currently being tested on monkeys in Florida — a collaborative effort with Dr. Camillo Ricordi, a pioneer in the field and the scientific director and chief academy officer of the University of Miami Diabetes Research Institute.

“Dr. Ricordi wants to find a cure for diabetes, and he doesn’t care how many people are involved in the process or share in the credit,” said Dr. Michael Shapiro, Hackensack’s chief of organ transplantation and leader of the diabetes partnership. “This collaboration will do great things for diabetes research.”

Diabetes occurs when the body cannot produce or properly use insulin, a hormone that helps the body metabolize glucose into energy and control blood sugar levels.

With Type 1 diabetes, sometimes called juvenile diabetes and the most serious form of the disease, the body’s immune system destroys the cells from the pancreas that make insulin, called islets. People with Type 2 diabetes make insulin, but their body doesn’t utilize it correctly and production of it typically declines as they age. More than 25 million Americans have diabetes, and about 3 million of those suffer with Type 1.

Health care experts expect the number of diabetics to increase dramatically, as obesity can trigger Type 2 diabetes and Americans continue to get heavier.

Living for years with unregulated blood sugar levels can cause a myriad of symptoms, some as severe as blindness, poor circulation that leads to limb amputation, and kidney failure.

Typical treatment for diabetic patients includes insulin pumps, injections and oral medications. Transplanting islets from deceased donors is sometimes effective, but it frequently triggers other complications because the islets need to be implanted in the liver. The number of organ donors also falls way short of the number of diabetics who would benefit from a transplant.

In this latest study with monkeys, Ricordi loads islets on a disc and then implants them in the abdomen, rather than in the liver.

“The challenge is we’re dealing with an autoimmune disease so we have to replace or get cells to regenerate that were destroyed,” Ricordi told dozens of HUMC executives, physicians and health care workers this week. “And the key is to do this without a lifelong regimen of autoimmune rejection drugs.”

Based on the success with the primates, Shapiro is hoping to have four patients undergo the procedure in early 2012, though recruitment hasn’t begun. The ideal patients will be those who aren’t responding to other treatments.

Physicians attending the announcement highlighted Ricordi’s expertise and advances in treatment of the disease.

His creation, the Ricordi Chamber, is so well-known in the field that it was mentioned in a recent episode of the medical drama “Grey’s Anatomy.” Critical for a transplant, it is able to efficiently separate islets from the pancreas.

But successfully transplanting the islets will only be part one of the cure. Researchers need to figure out how to create islets in the lab so there will be enough to treat all diabetic patients who need them. Another research team is working on that endeavor in the Miami institute.

Still, the partnership has hospital executives determined and diabetic patients hopeful.

“I’m absolutely sure we’ll find a cure,” said Robert Garrett, president and chief executive of HUMC.

Stephanie Stone, who was diagnosed with diabetes at 10 and is now 18, attended the announcement with her Franklin Lakes, N.J., family.

“I’m optimistic for the future,” Stephanie said. “If this isn’t a cure, it sounds like it’s a better treatment before a cure is found.”

CeQur Develops Diabetes Compliance Device

An important drawback of current diabetes treatment regimens is patient compliance, particularly for insulin injections that are painful and must also be timely administered. CeQur has developed an innovative technological platform to address this concern, actualizing a minimally invasive wearable drug patch infuser that provides relatively painless, continuous subcutaneous delivery of insulin in basal doses, as well on-demand doses at the push of a button. The company’s minimally invasive subcutaneous route of drug administration precludes the use of the existing injection-based insulin regimens that are burdensome to patients due to their painful nature, which can significantly lower patient compliance. The company has shown through clinical trials that its technology accurately delivers insulin while improving patient comfort and compliance, and is currently waiting health board approvals.

Jim Peterson, CeQur President and CEO contends that insulin delivery devices and technologies are coming and will be a major help for people with Type II diabetes, a major help for them in overcoming the barriers to taking insulin properly and consequently living longer and healthier lives. “People have always known that there are four times as many Type II diabetics taking insulin as Type 1, and 80 percent of all insulin in the world is consumed by Type II diabetics,” he said in an interview for Mass Device last year. “However, the Type II diabetic population has been very under-served as far as technologies helping them with that struggle. It’s estimated that the market is easily a $2 billion marketplace for this new generation of products.”

Wellness News

Companies Seek Outside Help On Health Costs

Healthcare costs can be expensive for a company both in money as well as time off for an employee with an extended illness. That’s why some employers have brought in wellness programs to help employees discover and treat unknown health issues, and learn how to live healthier.

Amanda Greene, a certified health education specialist with Valley Preferred in Allentown, said the cost of health insurance is driving interest in wellness programs.

“Increase in the level of commitment in activity has quadrupled in the last three to four years,” Greene said.

One employee with a heart attack and hospital stay for surgery could incur a hospital bill for as much as $250,000, Greene said.

This expense could affect a company’s insurance premiums, while possibly requiring a replacement during the employee’s medical leave. Even before a traumatic illness strikes, health issues can affect an employee’s productivity, she said.

Through health and wellness programs, “we will never know how many heart attacks we would have prevented,” Greene said, “but we can improve employee health.”

At an American Heart Association event last month, Martin Till, president of the Express-Times in Easton, said that when his company implemented a wellness program, healthcare costs dropped in four years.

The program wasn’t popular at first, but three months after its implementation employees came to him and thanked him for it. They told him it “saved their lives.” Their program included information about quitting use of tobacco products and losing weight.

“Now we have much healthier employees and a happier employer,” he said.

Till said that 80 percent of healthcare costs are related to health problems like diabetes, asthma, coronary artery disease, cardiac pulmonary edema, also known as congestive heart failure, and high blood pressure – some of which are preventable.

Destination Thailand to showcase best of Thailand’s festivals, produce, healthcare and wellness at Dubai Mall

The Royal Thai Consulate-General, together with the Tourism Authority of Thailand (TAT), Thai Airways International, the Thai Trade Center and Thai Business Council in Dubai, is set to hold a promotional event titled “Destination Thailand 2011″ from May 5-7, 2011 at the Star Atrium, Dubai Mall, as part of a series of events to celebrate the auspicious occasion of His Majesty the King of Thailand’s 84th birthday anniversary, and to directly promote Thailand’s festivals, tourism attractions, medical and wellness services, produce and hospitality service sectors to residents of Dubai.

The three day event is based on the theme of “Wonderful Thailand in 2011″ and will feature various information booths, cultural performances, quizzes, competitions, prizes and demonstrations that will highlight the major annual festivals held in Thailand including the festive “Songkran” or Thai New Year celebrations which are held in April, as well as the romantic “Loi Krathong” or Floating Lanterns festival which is held annually in November. Additionally, various informational booths and stands will provide visitors with information regarding Thailand’s tourism attractions, hopsitality services, medical and wellness services, spas and a Fly Thai Airways travel corner.

Says Mr. Pramoth Supyen, Director of the Tourism Authority of Thailand, Dubai and Middle East Office, “We are extremely happy to be associated with this special initiative headed by the Royal Thai Consulate General Dubai. In the iconic Dubai Mall we have a wonderful opportunity to directly introduce the very best that Thailand as a travel destination has to offer and encourage all to come join us for 3 days of everything fun, friendly and Thai!”

Throughout the event various cultural performances such as traditional Thai dancing performances and demonstrations on Thai fruit carving Traditional Thai massage techiques will be conducted. Additionally, informational sessions by some of Thailand’s leading hospitals will be conducted with each sessions followed by quizzes and exciting giveaways.

The “Destination Thailand 2011″ promotional event will be officially opened by His Excellency Mr. Somchai Charanasomboon, Thai Ambassador, Royal Thai Embassy of Abu Dhabi, United Arab Emirates at 6pm on Thursday 5th May, 2011 and will remain open until the end of Saturday 7th.

Natural remedies for spring allergies

For many people who suffer from allergies in the spring, the tried and true methods they have been using for years are certainly tried, but not necessarily true. Most allergy sufferers get little relief from antihistamines and decongestants and, in fact, these medications can sometimes do more harm than good.

An allergic reaction such as a runny nose or watery eyes represents an attempt by the body to rid itself of the hostile allergen, such as pollen, oak, birch or grass. An antihistamine will dry the body so that there are fewer symptoms. The problem is that without the runny nose or watery eyes, the allergens are delayed in leaving the body and the body takes longer to fully cleanse. And many antihistamines make people drowsy, which is seldom a good thing.

A homeopathic remedy can help the body respond more appropriately and stabilize itself without irritations like the drowsiness or dry eyes that can become painful when wearing contact lenses. But before delving too deeply into possible solutions, much good can result from determining and then minimizing the exposure to the allergen. This can be done by considering the home environment.

Before eliminating anything else, it is important to remember that open windows will compound the effects of allergy. Sufferers should not sleep with open windows. The same pollen residue that finds its way onto window sills and dressers is also on pillows and sheets and inhaled all night long as a person sleeps.

An air purifier with HEPA filter, by contrast, can add clean, fresh air to a room and that can be beneficial. An air conditioner works in the same way. It is just very important in either case to make sure that filters are cleaned or replaced regularly.

Mold is an allergen that poses a great risk to overall health. Make sure your house is free of mold. Damp basements are a common source of mold.

The real key with allergies is to help the body to respond in the right way. Like any other illness, for the body to respond effectively, it must be properly nourished and rest is vitally important. Heavily processed foods with lots of white flour or white sugar should be minimized. Stress and strain on the body must be reduced wherever possible and a good night’s sleep is essential to good health and to winning the battle with the allergens.

Avoid contact with allergens as much as you can. If you are allergic to grass you might want to hire a high school student in the area to cut it for you. Yard work should be put off when the pollen count is at its worst.

Quercetin is a substance found in foods such as the skin of red apples, in red onions and in black tea. It has many healthful effects. It can suppress the release of histamines from mast cells and as such is a natural solution to the problem of allergies.

We have a homeopathic remedy in our store called Allergy New England Mix. This is an oral spray that is specifically formulated to treat the allergens found in New England. Other off-the shelf treatments may be less effective because they are not specific to what is found in our environment. We have customers who begin using the product before the allergy symptoms begin and they generally find the symptoms to be much more manageable when they do occur.

Other homeopathic medications that have been used successfully by allergy sufferers include Natural Creations nasal spray, which can be used to safely reduce congestion. Histaminum are homeopathic pellets that can be placed under the tongue that also reduce symptoms. Another product that relieves symptoms and provides comfort is a special preparation just for people with mold allergies, called Allergy Atlantic Mold Mix. Lastly, consuming local or raw honey can help combat allergies.

The key in fighting allergies is to help the body work its magic, not hinder it by suppressing natural responses. A runny nose may be an inconvenience, but it is also proof your body is working, as if it were saying “attack, attack!” The trick is to minimize the impact these symptoms have on your daily living and to be as comfortable as possible.

Hotze Health & Wellness Center Addresses a Common, Often Misdiagnosed, Problem

As National Stress Awareness Month draws to a close, Hotze Health & Wellness Center (HHWC) emphasizes the importance of properly diagnosing and treating a common, but often misdiagnosed problem: adrenal fatigue.

“When mainstream physicians label patients with chronic fatigue syndrome they are simply reiterating the symptoms back to the patient”

Adrenal fatigue occurs when the adrenal glands do not produce adequate amounts of the body’s stress hormone, cortisol. Symptoms include: chronic fatigue, dizziness, recurrent infections, depression, dry skin and difficulty recovering from stress.

Adrenal fatigue is usually diagnosed as chronic fatigue syndrome (CFS), which is only diagnosing the symptom rather than the underlying cause.

“When mainstream physicians label patients with chronic fatigue syndrome they are simply reiterating the symptoms back to the patient,” said Steven F. Hotze, M.D., founder and CEO of HHWC. “If your doctor diagnoses you with chronic fatigue syndrome you should ask what is causing it.”

Most individuals are exposed to an onslaught of stressors – noise, pollution, traffic, injuries, illness, and emotional conflicts – that wear on an individual’s adrenal glands. The adrenals are simply unable to meet the demands resulting in a feeling of stress and chronic fatigue. Additionally, individuals suffering from adrenal fatigue oftentimes experience chronic and recurrent infections.

HHWC physicians recommend that those with CFS, which is just another name for adrenal fatigue, should supplement with bioidentical cortisol to replenish and support their adrenal glands in order to properly address the issue.