Quit Smoking News: EU launches new quit smoking campaign

2011-06-18 / Other / 0 Comments

EU launches new quit smoking campaign

Ex-smokers have more money, more freedom, better health and less stress than smokers, argues the European Commission in its new campaign, ‘Ex-smokers are unstoppable’. Launched on 16 June, it emphasises the advantages of quitting, whereas the previous two campaigns – ‘Feel free to say no’ (2002-2004) and ‘HELP’ (2005-2010) – stressed the dangers of smoking. This new action focuses on the benefits to smokers of kicking the habit and provides practical aid through the free iCoach platform, which also aims to help those not planning to quit and those in danger of taking up smoking again.

“As a former smoker myself, I know how hard it is to quit, but most importantly how gratifying it is. We need motivation and practical help, two things provided by this new campaign,” commented Health Commissioner John Dalli at the kick-off of the campaign in a park near the European Commission.

The campaign will run from 2011 to 2014 and specifically targets smokers between 25 and 34-years-old, which represents nearly 28 million people in the EU. Smoking is the leading cause of avoidable illness in the EU and the cause of death of more than 650,000 people in the Union every year. To date, 15 member states have passed laws that protect citizens on the whole from exposure to tobacco smoke.

Up in smoke: Tobacco issues

This year, more than 5 million people will die from a tobacco-related heart attack, stroke, cancer, lung ailment, or other disease. That does not include the more than 600,000 people who will die from exposure to second hand smoke.(1) Countries throughout the world are instituting tobacco control measures, such as the WHO Framework Convention on Tobacco Control, to help reduce the harm caused by smoking. World No Tobacco Day was May 31. Ashtrays with fresh flowers are a common symbol of World No Tobacco Day. Is an International Tobacco Control Project: Evaluating the impact of the WHO treaty across the globe, the answer?

Do you consider it your responsibility to help your patients quit smoking? If so, then you are in good company. The American Dental Hygienists’ Association (ADHA) thinks so as well. Also, a recent study that surveyed 231 periodontists found that 92% believe that tobacco-cessation interventions are a responsibility of the dental profession.(2) While the topics surrounding these issues are many, this issue will highlight how to reach younger smokers with a quit message, second hand smoke and risk for periodontitis, a message from the Smoking Cessation Leadership Center, and the hookah and its effects on oral health.
The Mexican pharmacy
In addition to systemic health issues, tobacco use and dependence causes oral health problems and has a great impact on the development and progression of periodontal disease. There is a clear causal relationship between smoking and periodontal disease and the negative effects of smoking on wound healing.(3) Smokers present tougher bacterial challenge to periodontal treatment than non-smokers.

Periodontal disease is difficult to successfully treat in any dental patient. One patient type that can be especially challenging is smokers. Smokers are up to 6X more likely to experience periodontal destruction compared to non-smokers.(4) A new study has found that smoking may pose other problems.(5) In patients with moderate-to-severe chronic periodontitis, researchers in this study found that smokers consistently demonstrated lower levels of health-protective bacteria, and significantly higher levels of disease-related bacteria subgingivally. These included higher levels of the red complex Treponema and Tannerella species, which have been linked to more severe and refractory periodontitis.(6,7)

This may help to explain why smokers are less responsive to scaling and root planing (SRP) alone, exhibiting smaller pocket depth reductions and fewer clinical gains resulting in deeper periodontal pockets.(4,8,9,10,11,12) In addition to other types of treatment, minocycline microspheres improve healing in patients who smoke. A study demonstrated that at 9 months, patients experienced 32% greater reduction in pocket depths with Arestin+ SRP vs. SRP alone.(9) Another study demonstrated that Arestin+ SRP was nearly 4X more likely to reduce pockets to <5 mm than SRP alone.(13) **

Tobacco-dependence treatment and tobacco cessation programs are vital components of clinical practice, and tobacco cessation programs should be incorporated into practice protocols. The use of tobacco cessation interventions by dental hygienists, general dentists, and oral maxillofacial surgeons has been reported in the literature. There is an ADA code for tobacco counseling in dental practice, D1320, and this can be used when cessation programs are implemented.

The primary barriers to providing tobacco-cessation interventions were low patient acceptance of treatment, lack of time, and lack of training. The following were other barriers cited: lack of reimbursement; believing that there was little chance of success in providing tobacco-cessation intervention; believing that patient acceptance of treatment is low; possibility of offending and losing patients; and lack of personal interest by the provider.

The basic steps of a tobacco-dependence treatment protocol can be implemented in three minutes or less. If the dental hygienist is familiar with community or state resources for tobacco-dependence treatment, like 1-800-QUIT NOW quit hot line, patients can be given information on these resources and referred for further assessment and assistance in quitting.

Ask, advise, refer is a shortened form of the 5 A’s (ask, advise, assess, assist, and arrange) — a series of steps to be used in a healthcare setting to treat tobacco use and dependence — and for promoting tobacco cessation. For more information, go to ADHA’s www.askadviserefer.org. When it comes to lack of reimbursement, while many insurance plans do not provide coverage for cessation counseling, this seems to be changing.

In a newly updated Cochrane Review, Cahill and Perera summarize the effectiveness of incentives for smoking cessation.(14,15) Their disappointing conclusion is that, while there is some evidence that incentives work in the short term, the effects generally dissipate, and there is still insufficient evidence to recommend their adoption into routine practice. Much therefore remains to be discovered, but what are the particular questions that this review highlights?

Behavior change has been divided into “simple” or single actions at a point in time, and “complex” behavior change are those requiring effort over a sustained period.(16) Adherence to medication is an example of a simple behavior change. A systematic review in the British Medical Journal (BMJ), which assessed financial incentives to motivate adherence to medical instructions, identified 11 randomized controlled trials.(17) The incentives ranged from USD 5 to about USD 1,000. Of the 11 studies included in the review, 10 demonstrated a positive effect. The studies incentivized several types of interventions, such as immunization, engaging with antihypertensive treatment, attending postpartum appointments, completing cocaine dependency treatment, and dental care for children.

Complex behavior change requires both sustained effort and typically the adoption of multiple strategies to achieve change. Tobacco and smoking cessation, and weight loss to reduce obesity, require complex behavior change. A systematic review of trials of incentives for weight loss found that larger incentives seemed more effective but that the effectiveness of interventions seemed to decline when the incentive was withdrawn, paralleling the data in the Cahill and Perera review.(18)

Should we conclude that incentives are effective for simple but not complex behavior change? This conclusion does not take into effect the strong evidence for the efficacy of incentives for the management of drug misuse.(19) There is also evidence for improved abstinence from problem drug use, clearly a complex behavioral change. Although ceasing to use illicit drugs does require complex change, some actions are simple. Deciding to engage in a treatment program and partaking in programs for supervised dispensing of methadone are simple behaviors. These are part of the set of behaviors that have been effectively rewarded in previous trials of incentives in drug misuse.

The shining exception to the rather negative findings in the Cochrane Review of incentives for smoking cessation is the trial by Volpp and colleagues.(20)

In the Volpp study, participants obtained rewards for attending a smoking cessation clinic and for validated abstinence. As a result, nearly three times as many in the intervention group attended as in the control group. The intervention also increased the rate at which participants achieved abstinence at short-term follow-up. Though a somewhat lower proportion of people who achieved early abstinence returned to smoking in the intervention group than the control group, it seems the main effect was inducing two simple behavior changes. One prompted individuals to decide to quit smoking, and the other prompted individuals to use evidence-based treatment.

Smoking in pregnancy is a difficult public health problem. A Cochrane Review of smoking cessation in pregnancy found that many of the interventions that are known to be effective in adult smokers are not known to be effective in pregnant women.(21) Financial incentives seemed the most effective intervention, increasing abstinence over three-fold. However, the outcomes of these trials were abstinence for the previous seven days, so the data are preliminary. According to the authors, many women who smoke in pregnancy are among the most disadvantaged in society. If incentives have a place in smoking cessation, it is perhaps this group who might be seen as the most deserving.

Both this review and the Cahill and Perera review show us the potential value of incentives. They appear to work sometimes for some smokers. Understanding how they work, whether the benefits are sustained, and that their effects are not due to gaming the system, is a public health priority.

Tobacco use is the single most preventable cause of disease, disability, and death in the United States. Each year, an estimated 443,000 people die prematurely from smoking or exposure to second hand smoke, and another 8.6 million live with a serious illness caused by smoking. The CDC issued a brief entitled “Tobacco Use: Targeting the Nation’s Leading Killer, At A Glance 2011”.(22)

The tobacco use epidemic can be stopped. The Institute of Medicine (IOM) report, “Ending the Tobacco Problem: A Blueprint for the Nation”, presents a plan to “reduce smoking so substantially that it is no longer a public health problem for our nation.(23) Foremost among the IOM recommendations is that each state should fund a comprehensive tobacco control program at the level recommended by CDC in Best Practices for Comprehensive Tobacco Control Programs–2007.(24) This publication is a guide to help states plan and establish effective tobacco control programs to prevent and reduce tobacco use.

Evidence-based, statewide tobacco control programs that are comprehensive, sustained, and accountable have been shown to reduce smoking rates, tobacco-related deaths, and diseases caused by smoking. A comprehensive program is a coordinated effort to establish smoke-free policies, reduce the social acceptability of tobacco use, promote cessation, help tobacco users quit, and prevent initiation of tobacco use. This approach combines educational, clinical, regulatory, economic, and social strategies. Research has documented the effectiveness of laws and policies to protect the public from second hand smoke exposure, promote cessation, and prevent initiation by young people.

CDC also promotes MPOWER, a package of six proven strategies identified by the World Health Organization (WHO) that can help reduce tobacco use and tobacco-related illness and death.(26) Monitor tobacco use and prevention policies; Protect people from tobacco smoke; Offer help to quit tobacco use; Warn about the dangers of tobacco; Enforce bans on tobacco advertising, promotion, and sponsorship; and Raise taxes on tobacco.

CDC, in partnership with the National Cancer Institute, the North American Quitline Consortium, and state tobacco control programs, has developed the National Network of Tobacco Cessation Quitlines. By calling 1-800-QUIT NOW, callers from across the nation have free and easy access to tobacco cessation services in their state.(27)

So what are you waiting for? With all these resources, there is no excuse not to assist your patients with tobacco cessation. If not you, who? If not now, when?

Will Quitting Smoking Make You Fat?

Many smokers who want to quit are afraid they will gain weight, so they rather not kick the habit. The fear of getting fat after quitting is not altogether unwarranted. Many ex-smokers do put on some extra weight, about five pounds on average.

Now, scientists think they know why. Recent studies have shown that nicotine helps suppress appetite by activating certain receptors in the brain, especially those in the so-called “reward regions,” where we sense pleasure and from where many of us also develop addictions.

A team of researchers at Yale University School of Medicine now found that nicotine can also bind regulator neurons to these receptors, which send out satiety messages, much like the signals our brain receives when our stomach is full to make us stop eating.

This mechanism may explain why smokers are usually not as hungry when they smoke and why they tend to eat more after quitting.

Considering the implications of their study results, some scientist now hope to develop a drug that can simulate the effects of nicotine on the brain, thereby eliminating the health hazards commonly attributed to tobacco use. Appetite-controlling drugs, like cytisine, to help quitters avoid unwanted weight gain are already available in Eastern Europe but not in the U.S.

Developing drugs that target specific receptors in the brain is a difficult challenge. Some scientists involved in this kind of research have warned that even if drug treatments were to prove effective, they may also trigger some unwanted side effects. The reason is that the receptors in charge of regulating appetite are also closely connected to the body’s stress responses, which normally are only mobilized in times of acute danger. Activating these receptors on an ongoing basis through medication could lead to symptoms similar to chronic stress and, over time, to diseases like high blood pressure and heart disease.

Of course, everyone agrees that fear of gaining weight should not ever prevent smokers from quitting. Instead of waiting for a wonder drug that might help people stay slim, there are many better ways to regulate one’s appetite and manage one’s weight more naturally.

A good way to start is to be more conscious of the metabolism. Smoking raises the metabolic rate and also increases the heart rate up to 20 times of normal. This is one reason why many smokers suffer from high blood pressure and heart disease.

When smokers quit, their metabolism slows down considerably. It can take weeks or even months before metabolic levels stabilize at normal levels. Meanwhile, calories are being burned at a much lesser rate. At the same time, many recovering smokers eat more food to cope with withdrawal symptoms or boredom. Senses of taste and smell come back to life after quitting, which may increase appetite as well.

Alcohol is often used to “take the edge off” when the cravings become more intense. Alcoholic beverages, of course, have lots of calories, and all too often these are not taken into account.

Another reason for increase of food intake is what smokers call “oral gratification.” Many ex-smokers miss the feeling of “having something to do with their mouths and hands.” Frequent snacking often serves as a substitute to fill the void.

Many people reach for food for similar reasons smokers reach for cigarettes, namely to handle stress, to reward or comfort themselves, to pass time, deal with boredom or to be social. For smokers trying to quit, the choice of means may change but not necessarily their behavioral tendencies.

So, is there a special regimen for ex-smokers to avoid falling into the weight gain trap? Not really. Ultimately, they have to act just like the rest of us who try our best to stay in shape: Healthy eating, limiting portion sizes, no snacking, regular exercise, stress reduction and enough sleep. Following all these measures combined should render any wonder drug of the future obsolete right now.

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Stop Smoking News

2011-05-24 / Other / 0 Comments

Kicking the hard-core habit

Meg Dougherty and Darlene Richardson are pleasant, well-mannered women, but in the world of smoking-cessation counseling, they rank among the hard cases.

Dougherty started smoking cigarettes sometime in her 20s. She’s not sure how many attempts she has made to stop, but nothing worked for more than six months.

Richardson remembers exactly how and where she started: at a party shortly after her marriage at 21. And she stayed hooked for decades, even when “it made me feel like I was taking my tongue and licking an ashtray.”

Then, at age 50, both women enrolled in the JeffQuit smoking-cessation program at Thomas Jefferson University Hospital. The program, which instructors offer at sites around the country under the name QuitSmart, is for anyone 18 or older, but especially for those who have tried to stop and failed.

“It’s almost been too easy,” said Dougherty, a nurse who reports being smoke-free since March 2. “It’s the first time I can see myself quitting for years and years.”

Cessation researchers and counselors say that with the growing public awareness of smoking’s health risks, social rejection through smoke-free areas, and the rising price of cigarettes, it’s mostly folks such as Dougherty and Richardson who are left.

“Individuals who have continued to smoke despite pressure to quit tend to be more ‘hard-core’ than were smokers of several years ago,” says Robert Shipley, who developed the QuitSmart program (the parent of JeffQuit) and has led the Duke Medical Center Stop Smoking Clinic since its inception in 1977.

To reach this group, physicians, therapists, and researchers are enlarging their bag of tricks, repackaging old techniques, trying newer ones like acupuncture, and looking for genetic clues to what makes it harder for some people to quit.

They are prescribing antismoking drugs more aggressively while taking a gentler approach in counseling. One might call it “talk softly and carry a big prescription pad.”

“In every smoker, there’s a non-smoker trying to come out,” says Frank Leone, who directs the Comprehensive Smoking Treatment Programs at the Hospital of the University of Pennsylvania. “We want to make that as easy and effective as possible. The field has shifted toward being more supportive. ‘You deserve not to smoke and here’s how we’re going to do it.’ ”

Leone drew up the “Quit Smoking Comfortably” curriculum used in the free smoking-cessation classes and workshops offered by the Philadelphia Department of Public Health. The mix of prescribing and counseling is similar to that of QuitSmart.

Lorraine Dean, manager of the department’s Tobacco Policy and Control Program, said that about 800 people have taken the program in the last year.

Statistics bear out the need to reshuffle the smoking-cessation deck. As the percentage of adults who smoke has slowly fallen, so has the effectiveness of cessation programs.

At the time of the first Surgeon General’s Report in 1964, about 42 percent of adults over the age of 18 smoked cigarettes. By 2009, the figure was just under half that, although the decline has slowed in recent years.

But at the same time, Shipley says, smoking-cessation programs have proved less successful. He cites one study showing that the success rate (6-12 months of abstinence) grew from about 20 percent in 1965-69 to about 30 percent in 1970-74, but has been declining in recent years, slipping back to around 20 percent.

Prospective quitters may be getting some help on the DNA front.

A new study by researchers at the University of Pennsylvania indicated that the number of so-called mu opioid receptors in the brain may show why many people find it so tough to quit.

“For the first time, we’ve identified a mechanism that explains why people with a particular genetic background may be more prone to relapse when they try to quit smoking,” said study director Caryn Lerman, a psychiatry professor at the Penn medical school. Nicotine, she said, releases brain chemicals such as beta-endorphins, and those with more of these receptors found nicotine more pleasurable.

Medications that block the activity of these receptors have had mixed results, but further research may show how they can become more effective, Lerman said.

The researchers used positron emission topography (PET), a nuclear imaging technique, to measure the amount of mu opioid receptors in smokers’ brains. The machines are too expensive for use in treating individual smokers, Lerman said. But “eventually, we hope to be able to predict who will have the easiest time quitting” and design programs more tailored to the individual.

Meg Dougherty was sitting in a small circle of chairs in an exercise room in Jefferson’s Center City complex. “I feel like I should be wearing a ’smoke-free’ tiara,” said Dougherty, who lives in Overbrook.

Sitting beside her, smoking-cessation counselor Anna Tobia was a verbal streaming billboard of encouraging messages for Dougherty and two others. “You have to try new ways of coping, that’s what this comes down to. . . . You’ve given up so much. . . . I feel like without a doubt you’re going to stay.”

The four-week program costs $249, though many insurance plans will cover $200. It is based on moving slowly into abstinence. Tobia calls it a “warm chicken” approach compared with the “cold turkey” methods used years ago. Participants attend an opening class and then ease down into quitting by smoking progressively weaker brands of cigarettes. They may even have started wearing a nicotine patch before the program begins, flooding their bodies with nicotine the way one might have a large meal to kill the appetite. Nicotine gum and lozenges also are used.

Smokers who have tried and failed to quit are being reached with a program of supportive counseling, drugs, and other techniques.

Other weapons in the program’s arsenal are a tobacco-free fake cigarette with an adjustable draw to help them disassociate the hand-to-mouth movement of smoking from the pleasure sensations that follow – and discounted acupuncture and stress-reduction programs. There is also a self-hypnosis CD that another QuitSmart practitioner, Lafayette Hill and Jefferson University Hospital psychiatrist Francisco Merizalde, finds particularly helpful. “It’s the combination that makes it work,” he says.

The most commonly prescribed drugs are Chantix and Zyban, which contains the same medicine as the antidepressant Welbutrin. (It’s used to help break the addiction; there’s no assumption that smokers are depressed.)

Chantix was prescribed sparingly in past years due to possible side effects including depression and suicide attempts. But Shipley and other cessation experts say it is generally safe if used under supervision and that if nothing else works, it’s still a lot safer than continuing to smoke. He believes that a combination of drugs and mental reinforcement is most effective with most longtime smokers.

Whatever is prescribed for QuitSmart clients, however, it is buttressed by supportive group sessions and a self-hypnosis CD. Tobia makes herself available as much as possible by cellphone and frequently calls or e-mails clients while they are in the program or after completion.

New York City Smoking Ban Starts Today

Beginning today, Monday, May 23, 2011, smoking is not allowed in outdoor public spaces around New York City, including beaches, parks and plazas. (That means Central Park, Yankee Stadium, the Coney Island boardwalk and so on — or everywhere it’s fun to smoke.) Health officials have pointed toward second-hand smoke as the reason for the new policy. But will police actually be patrolling for public smokers? How will the ban be enforced in a city full of smokers? And what will happen to the loosie man?

The city is leaving most of the enforcement responsibility up to us. “We expect the new law will be enforced by New Yorkers themselves, who will ask people to follow the law and stop smoking,” read a joint press release from the Parks, Health and Transportation Departments. So look forward to some shouting matches on the Great Lawn.

But there’s also a $50 fine, if the complainer can get someone in charge to pay attention:
Q: What is the penalty for smoking in a park or other area where smoking is prohibited?

A: We expect that the new law will be enforced mostly by New Yorkers themselves, who will ask people to follow the law and stop smoking. This is how similar laws have worked in other places, including Chicago and Los Angeles. However, people who violate the new law could receive a $50 ticket.

Q: What should I do if someone refuses to stop smoking in a park, beach or other area where smoking is prohibited?

A: New Yorkers are encouraged to inform a Parks Department employee or a Park Enforcement Officer if one is available. Otherwise, complaints can be made by calling 311.

The city is also planning an ad campaign to alert everyone of the changes.

Expert smokers, who still own the sidewalk, to be extra aggressive today, exhaling onto every baby they see.

Reynolds Suggests Snusing As Tobacco Ban Takes Effect

The Wall Street Journal ’s David Kesmodel writes that R.J. Reynolds is “seizing on new antismoking laws in New York City” while the Winston-Salem Journal’s Richard Craver says the hometown tobacco company is merely “attempting to make lemonade” out of the ban on smoking in the city’s parks, beaches, boardwalks, and pedestrian plazas that was signed into law in February and takes effect today.

Whether you see it as an aggressive ploy to fill the void left when the last wisp of cigarette smoke wafted into the ozone layer at midnight, or as defensive move to salvage some sales out of yet-another intrusion on personal freedom, Reynolds has launched a newspaper campaign for Camel Snus this morning in local New York newspapers (except the New York Times, which does not accept tobacco advertising) as well as USA Today and the Wall Street Journal.

CSPnet.com has some thumbnail images of the full-page ads, which carry the headlines “NYC Smokers Enjoy Freedom Without the Flame” and “NYC Smokers Rise Above the Ban.” “Smokers, switch to smoke-free Camel Snus and reclaim the world’s greatest city,” reads the copy in one of the ads.

An R.J. Reynolds’ spokesman says the company simply wants to “make adult smokers in the city aware of a smoke-free tobacco product that’s available to them” and that “as trends in tobacco use change, Camel is transforming by offering adult smokers options, like smoke-free Camel Snus, to consider switching to.” It refers to the products as “spit-free, smoke-free, mess-free tobacco that comes in a small pouch” on its website. “Just slide it under your upper lip and enjoy.” It also plays up the two-century-old Swedish heritage of the product.

“Some public-health advocates, pointing to the difficulty of quitting smoking, argue that products like snus could play a role in reducing tobacco-related harm,” Kesmodel writes. “Others say the products may entice more people to take up tobacco, and could keep smokers who otherwise might drop tobacco altogether from doing so.”

Bill Godshall, the executive director of SmokeFree Pennsylvania, tells Craver that Reynolds is the first large U.S. tobacco company to encourage smokers to quit smoking by urging them to switch to a smokeless product. The ads, however, do not make any claims of reduced health risks, which doesn’t mean that anti-smoking groups find them acceptable.

“These ads continue Reynolds’ irresponsible marketing of snus as a way for smokers to get their nicotine fix in the growing number of smoke-free places,” says Campaign for Tobacco-Free Kids spokesman Vince Willmore.

In a separate piece in yesterday’s Winston-Salem Journal, Craver reports that Matthew Carpenter, an associate professor in the department of psychiatry and behavioral sciences and the department of medicine at the Medical University of South Carolina, is conducting a federally funded study that aims to answer two key questions in the debate: 1. Can a smokeless product … contribute to a smoker quitting cigarettes — particularly one who doesn’t want to stop? 2. If it does, could an increase in use of smokeless-tobacco products over cigarettes cause a net harm to the population?

But Matt Myers, president of the Campaign for Tobacco-Free Kids, says research should also evaluate whether the marketing of smokeless products result in more people actually using tobacco, “which could result in more deaths, not fewer.”

Craver discusses some prior research that indicates that the use of smokeless products may be effective in curbing withdrawal and craving among smokers who want to quit. But, he points out, “the evolution of some health-advocacy groups from anti-smoking to anti-tobacco is ratcheting up the moralistic aspect of buying and consuming a legal product.”

Ken Kendrick, the managing general partner of the Arizona Diamondbacks, published an op-ed piece in the Arizona Republic yesterday that calls on Major League Baseball to enact a ban on smokeless tobacco just like one that has been in effect for minor leagues teams since 1993.

“Ballplayers aren’t indulging a harmless habit when they use smokeless tobacco,” he writes. “They’re damaging their health with a product that causes cancer and other serious diseases. And they’re endangering the well-being of countless kids who look up to them and who copy everything major leaguers do.”

Kendrik says that while cigarette sales are down, the promotion of smokeless products as a substitute is having an effect: Smokeless-tobacco use by high-school boys has risen 36% since 2003. “Every time a kid sees a major-league player using smokeless tobacco,” he writes, “baseball is contributing free promotion.”

Tobacco use falls despite cuts to funding

Emily Kecskemety, a senior at Pittsford Sutherland High School, was watching the movie Hairspray one day and was bothered by all the smoking in the film.

The big-screen version of the Broadway musical had scenes with teens smoking in a high school bathroom, teachers smoking in the faculty lounge and pregnant mothers smoking during a dance number, even though it was a PG-rated movie.

She and other members of Reality Check, a high school club aimed at preventing teen smoking, created an awareness-raising activity out of the movie.

“A group of us decided to play a game and stomp our feet every time we saw something smoking-related and we couldn’t believe the significant amount of times we did see something,” Kecskemety, 17.

Pittsford’s Reality Check is one of a few teen-run anti-tobacco efforts still in existence in Monroe County after federal and state funding for such groups were cut. And although teen smoking rates are declining, concern remains that without such peer programs, the rates could again rise.

“These groups have to stay alive because smoking companies target teens and teen awareness efforts are some of the main reasons why smoking has gone down,” said David Walling, former Monroe County coordinator of Reality Check. “When teens educate other teens about the ways that tobacco companies are focusing on younger kids to get them hooked, kids get totally offended because they don’t want to be duped.”

Cigarette use by high school students declined from 27.1 percent in 2000 to 12.6 percent last year, according to the state Department of Health.

Close to 80 percent of adult smokers began before age 18, according to the Campaign for Tobacco-Free Kids.

New York budgeted $47 million in 2011-12 for tobacco-prevention initiatives, said Morris Peters, spokesperson for the state budget office, down $17 million from last year. Three years ago, the state spent upwards of $80 million annually on programs.

The New York state Department of Health Tobacco Control Program helps run Reality Check, a statewide initiative empowering youth to participate in reducing tobacco use among peers, removing tobacco advertising from magazines delivered to schools and removing tobacco use from movies rated G, PG and PG-13.

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Dental Care Today

2011-05-18 / Other / 0 Comments

New Jersey Dentist Expands Sleep Apnea Expertise at Prestigious Dental Institute

As a cosmetic dentist in New Jersey, Dr. Jerry Strauss focuses on the overall oral health of his patients as he strives to create and maintain the smiles they desire. As part of his commitment to complete oral care, he often treats symptoms of sleep apnea to help his patients avoid common side-effects ranging from hypertnesion to heart disease, which is why he recently completed a comprehensive 3-day sleep apnea course at the internationally recognized Las Vegas Institute for Advanced Dental Studies.

Fairfield, NJ (PRWEB) May 17, 2011

At his New Jersey cosmetic dentistry practice, Jerry Strauss, DMD says he strives to provide comprehensive dental care to enhance his patients’ overall oral health. While he specializes in improving their smiles with procedures such as teeth whitening or porcelain veneers, he stresses the need to address patient concerns on a case-by-case basis, which can include a variety of concerns, from sleep apnea to TMJ treatment. As part of this dedication to providing complete oral care, Dr. Strauss recently traveled to the Las Vegas Institute for Advanced Dental Studies (LVI) for a post-graduate course on successful treatment of sleep apnea.

At LVI, Dr. Strauss says day-1 of the sleep apnea program included a comprehensive presentation that not only focused on the effects of sleep apnea on adults, but also how this deadly disease can affect children. Day-2 of the LVI course concentrated on obstructive sleep apnea, and the need for immediate treatment to help patients manage the disease and improve overall quality of life. And finally, Dr. Strauss says day-3 included a presentation from the Dr. Brian Allen, an expert in dental sleep medicine. Ultimately, Dr. Strauss says he has a new appreciation for the disease, adding that the course will be helpful in his practice and personal life, as he too suffers from the effects of sleep apnea.

Whether enhancing a patient’s smile with porcelain veneers, treating the host of medical problems associated with sleep apnea, or reducing his patients’ level of anxiety with sedation dentistry, Dr. Strauss says he constantly strives to create a positive experience with each office visit. Maintaining a steadfast commitment to continuing education courses is yet another essential element of his New Jersey practice’s success. As Dr. Strauss returns to his practice from the Las Vegas Institute for Advanced Dental Studies, he says he believes he is better equipped to treat and manage sleep apnea, and help his patients continue to share their beautiful smiles.

About Dr. Strauss

Jerry M. Strauss, DMD earned his dental degree from Boston University’s School of Graduate Dentistry. He then completed a general practice residency at SUNY Upstate Medical Center, where he also served as a clinical instructor. Dr. Strauss has achieved Master Status with the Academy of General Dentistry by completing 1100 hours of continuing education, which is the highest honor the academy offers. He is also a member of the American Dental Association, the American Academy of Cosmetic Dentistry, and the Dental Organization for Conscious Sedation.

Expanding 40 years of necessary medical care

The growing pains forcing expansion of the Henrietta Johnson Medical Center confirm how much the Southbridge health care agency has become a gem to the city of Wilmington.

Monday’s kickoff of a $4 million campaign to more than double its response to growing demand for dental care, women’s health screenings, prenatal and pregnancy care and routine family health services secures HJMC’s role as a “medical home” for the unemployed and uninsured.

And the campaign will prepare HJMC for the coming federal health reform mandates that begin in 2014.

In the last five years, requests for service grew 17 percent. Nearly 7,000 patients were serviced, with 66 percent falling below 200 percent of the federal poverty guideline and 84 percent of that group below 100 percent of the guideline. Inadequate exam and treatments rooms prevent hiring new medical staff, and women’s services are busting at the seams.

The numbers tell much about trends in unmet health needs in northern Delaware. For example, dental visits increased by 83 percent, but 10 percent of slots are reserved for walk-in emergency cases. The expansion will provide for another dentist and dental hygienist and help HJMC continue to provide health care to homeless families at no cost.

But most important, for those fortunate enough to have medical insurance, this campaign allows HJMC to continue to be a buffer against a rise in their premiums as well. Health insurers typically pass on the costs of caring for uninsured patients to those who have insurance.

Amerigroup Foundation Supports Health Services for Virginia’s Uninsured

The Amerigroup Foundation announced that it will provide more than $150,000 in support of the delivery of health care services to uninsured Virginians. The majority of this donation will be directed toward the southwest region of the state and the 2011 Remote Area Medical® Health Expedition in Wise County, Va., this July. Organizations receiving funds include The Health Wagon, the Virginia Dental Association Foundation and The University of Virginia Office of Telemedicine.

The Remote Area Medical® Volunteer Corps is a nonprofit, all-volunteer medical relief corps serving remote and impoverished areas of the United States and abroad. In Virginia, the Virginia Dental Association Foundation (VDAF), a local free clinic, The Health Wagon, and The University of Virginia annually team up with RAM to spearhead a three-day event, providing eye, dental and medical care to the uninsured and underinsured in the region.

“This project represents positive and worthwhile endeavors that promote and enhance access to health care delivery for citizens of Southwest Virginia,” said Teresa Gardner, RN, FPN, DNP, executive director of The Health Wagon. “We are very thankful for Amerigroup’s support for us to continue valuable and needed services.”

“Amerigroup has allowed us to expand our reach into underserved communities,” said Dr. Terry D. Dickinson, executive director of the VDAF. “Their support will create $1.28 million in free dental care, benefit the community at large, decrease the disparities in health care, increase health literacy and encourage better personal choices through not only the RAM Health Expedition, but also VDAF’s additional Mission of Mercy projects.”

“The University of Virginia is delighted to partner with the Amerigroup Foundation to expand access to high-quality specialty care services via our telemedicine network. We have facilitated more than 22,000 clinical encounters sparing patients more than 6.5 million miles of travel for access to health care services. In many cases, the patients we have served might otherwise never receive care in a timely fashion. This partnership enhances our ability to serve patients in need when they need care, regardless of geographic and financial barriers to access,” said Dr. Karen Rheuban, medical director of the University of Virginia Office of Telemedicine.

Last year’s RAM Health Expedition event was the largest of its kind in the nation, drawing individuals from more than 16 states. Run with the help of 1,746 volunteers, $2.3 million in free care was provided to more than 2,800 patients with 5,683 distinct encounters. This year’s event is expected to draw more than 3,000 patients.

“The Foundation is thrilled to be able to provide not only funds, but also volunteers, to support the amazing work of the RAM,” said John E. Littel, chairman of the Amerigroup Foundation. “We will be able to directly connect, better understand and strengthen the long-term health needs for individuals who are uninsured or underinsured.”

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Gout Treatment News

2011-05-07 / Other / 0 Comments

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.

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Hair Loss Prevention News

2011-04-16 / Other / 0 Comments

AQ Skin Solutions Launches Growth Factor Technology to Deliver Advanced Anti-Aging Skin Care and Hair Loss Prevention

MISSION VIEJO, Calif., April 14, 2011 /PRNewswire/ — AQ Skin Solutions, a leading research and development lab in the skin care industry, today announced the worldwide launch of its Growth Factor (GF) technology, a cutting edge technology producing human growth factors to be used in topical skin care products. AQ Active Serum®, AQ Eye Serum®, and AQ Advanced Hair Complex+® make up the new line of advanced skin care products focused on resolving multiple skin conditions, including hyper-pigmentation, discoloration, acne and lines, wrinkles, and hair loss.

The new line of AQ Skin Solutions products is based on Growth Factor technology, a patent pending procedure of human growth factors production. Growth factors are a group of specialized proteins with many functions—the most important being the activation of cellular renewal. GF can be found in many different cell types in the human body, turning essential cellular activities “on” and “off”, and playing a variety of roles that help to maintain the skin’s youthful appearance, particularly increasing cell renewal, cell defense, blood circulation, and collagen and elastin production.

“GF technology is the future of skin care,” said Dr. Ahmed Al-Qahtani, professor of medicine, and founder of AQ Skin Solutions. “In recent decades, scientific research into GF biological functions has shown that GF technology is related to resolving many cell developmental diseases. And when applied to skin care, GF technology can help people achieve a more youthful and vibrant look without expensive plastic surgery or other cosmetic treatments.”

Weaves lead to scarring, hair loss, scalp problems

Seems like everyone these days suddenly has the long, luscious locks of Rapunzel.

Weaves have allowed many of us to have the hair that nature didn’t give us.

But these weaves are now causing health issues for many African American women.

A recent study found that braids, weaves and other types of hair extensions may be contributing to scarring of the scalp and hair loss in African American women.

Researchers at the Cleveland Clinic in Ohio issued questionaires to 326 African American women about hair loss. Hair loss in the center of the scamp and clinical signs of scarring were seen in 59 percent of the women who responded.

Type 2 diabeties was also higher in the women with hair loss, suggesting that metabolic irregularities may contribute. Bacterial scalp infections and braids and weaves also seemed to contribute.

So, ladies, although you may want hair down your back, think of the consequences that may come with getting it. Maybe lay off the weaves and be glad about what you have naturally.

Cap device could reduce chemotherapy hair loss

For many women facing the emotional and physical whirlwind of breast-cancer treatment, the possibility of losing their hair is one more trauma to go through.

“It’s typically two of the first questions I get – will I lose it, and when will I lose it,” said Dr. Susan Melin, who specializes in treating breast cancer as an associate professor of internal medicine – hematology and oncology – at Wake Forest Baptist University Medical Center, in Winston-Salem, N.C.

“They feel like it is a declaration to the world of their condition and the chemotherapy that they’re about to go through.”

Melin hopes that a feasibility study of a scalp-cooling device – just under way at Wake Forest Baptist – will enable her to eventually answer “no” more often to those questions.

“Preventing chemotherapy-induced hair loss by using the scalp-cooling cap may relieve severe psychological and emotional stress and improve the patient’s quality of life,” Melin said.

The Food and Drug Administration has approved Wake Forest Baptist and the University of California at San Francisco for an investigational device exemption for DigniCap, which is made by Dignitana of Lund, Sweden. The study is the first step required to gain FDA approval. Melin is the principal investigator for the Wake Forest Baptist study.

The device, aimed at patients with Stage 1 breast cancer, is already in clinical use in Canada, Europe and Japan. According to the Dignitana website, more than 80 percent of the patients have kept their hair during chemotherapy.

Both U.S. medical centers will enroll 10 patients. The first patient at Wake Forest Baptist is set to undergo chemo treatment while wearing the cap on Wednesday. UCSF has at least five patients enrolled.

The device is a tight-fitting silicone cap placed directly on the head, and an outer neoprene cap that insulates and secures the inner one. The cap is connected to a cooling and control unit with touch–screen controls. The design leaves the ears uncovered.

A coolant circulates throughout the inner silicone layer. The cap is designed to deliver consistent cooling to all areas of the scalp. The device features safety sensors that monitor and optimize the treatment temperature, typically around 42 degrees. A lower temperature is recommended for patients with thick hair.

When a cap is applied to the head, the temperature of the scalp is lowered over a 20- to 30-minute period. Blood vessels surrounding the hair roots contract, resulting in a significant reduction of cytotoxins to the follicle.

Reduced blood flow leaves a smaller amount of chemotherapy available for uptake in the cells. The decreased temperature results in less absorption of – and reduced effects from – the chemotherapy.

The treatment cycle, depending on the patient, would range from four times over a two–month period to eight times over a four-month period, Melin said.

Melin said there have been few side effects with the cap, primarily headaches. “One of the goals with the study is determining it is safe with no side effects,” she said.

Patients will have follow-up visits of three, six, nine and 12 months to determine whether hair has grown back.

Melin said that a larger efficacy study would include patients with Stage 1 and Stage 2 breast cancer.

“Basically, the DigniCap would be used for certain patients who have a moderate chance of their cancer recurring,” she said.

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Health Care Systems Today

2011-04-13 / Other / 0 Comments

Americans Like Their Health Care, But Think The System Stinks

If America has the best health care system in the world, as some people like to say, then the setups in other countries must really be crummy.

How come? Well, check out the disheartening results of a poll just out from the Robert Wood Johnson Foundation and the Harvard School of Public Health. Fifty-five percent of adults surveyed gave the U.S. health care system a C or D, when asked to assign it a grade. Eleven percent gave it an F.

Can we send the health system to its room until it gets those grades up?

Familiarity trumps data when it comes to picking a hospital, the poll finds. Most people — 57 percent — would chose a hospital they or someone they know has had experience with over a hospital that does well on quality measures — 38 percent.

Indeed, when it comes to health care, people’s views are a little more charitable when the questions focus on their personal experience instead of the abstract. When asked about the quality of care they’ve actually received, nearly a third — 31 percent — of people give it an A. Thirty-four percent say it’s a B. Only 13 percent grade it D or F.

When it comes to some things, such as picking a surgeon, data seem to count for a little bit more. People were pretty much evenly divided on whether the experience of family or friends would be decisive (48 percent were in that camp) and about an equal proportion (47 percent) leaned toward quality ratings.
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Data-driven decision making for surgery, at least, seems to be gaining steam. In 2000, the same question got 50 percent in the family-and-friends column and 38 percent in the quality-ratings column.

The results were presented at a meeting of the American Hospital Association. In a statement, Robert Blendon, professor of Health Policy and Political Analysis at the Harvard School of Public Health, said:
The pace of change in having consumers use independent expert ratings when they choose a hospital has been slower than anticipated. More can be done to encourage this.

Blendon’s group conducted the poll, which included responses from 1,034 people and has a margin of error of +/- 3.7 percentage points.

Health Care Reality Check

PART ONE

Satire

It’s Tuesday, April 12th.

After a leaked draft put Conservatives on the defensive about questionable infrastructure projects, the Auditor General is urging Canadians to wait for her office’s final report on G8 and G20 summit costs.

Currently, turns out they got the Fake Lake for half the cost of an actual lake.

This is The Current.

Health Care Reality Check – David Dodge

We started this segment with a clip of three Canadians talking about their stuggles with illness. Going into this election, more Canadians picked health care as their top political concern over any other issue. Given that, you might think health care would be a key election issue. But as the federal leaders hunker down in preparation for tonight’s English-language debate, health care seems to have been largely side-lined.

This morning, we focused on the problems and hopefully some solutions on health care. We began with the pessimistic perspective of former Bank of Canada Governor, David Dodge. In a new report for the CD Howe Institute, he argues our current health care system is unsustainable and that governments will have to make difficult choices to fix it. David Dodge was in Phoenix, Arizona this morning.

Health Care Reality Check – Michael Rachlis/Diana Gibson

Not everyone agrees with David Dodge’s assessment. Michael Rachlis is a health policy analyst and an associate professor at the University of Toronto. And Diana Gibson researches health care policy and she’s the Research Director at the Parkland Institute at the University of Alberta in Edmonton.

Tenet Healthcare Files a Lawsuit against Community Health Systems

Tenet Healthcare, which is struggling against a takeover bid by Community Health Systems, has filed a lawsuit saying that the rival hospital chain overbilled Medicare by almost $1 billion over three years.

Though Franklin-based Community Health is pretty determined to stick to its stance of buying Tenet but this lawsuit by Tenet has caused the stocks of both the companies dip down, further affecting the chares of other hospitals.

Referring to Tenet’s claim as a baseless attempt to distract shareholders, CHS officials said that it had become quite clear that Tenet had adopted a scorched earth defense without giving any thought about the best interests of shareholders.

Tenet has made serious allegations saying that CHS has always been trying to convert emergency room visitors into admitted patients in order to squeeze more money out of the Medicare whereas there was a possibility of keeping all those patients in a less expensive setup.

Sheryl Skolnick, an analyst with CRT Capital in Stamford, Conn., said, “Community Health needs to lift up the curtains and show Wall Street, investors and others how it is able to have observation rates (of patients) much lower than the industry average”.

Pardee Hospital & UNC Health Care System Discuss Possible Collaboration

Pardee Hospital has entered into an agreement to explore a possible relationship with University of North Carolina Health Care System (UNC HCS). UNC HCS is a not-for-profit, integrated health care system located in Chapel Hill, North Carolina. Along with Pardee Hospital, UNC HCS has been recognized nationally for patient centered care that focuses on providing safe, cost-effective, and quality healthcare services.

Current discussions between the Pardee Hospital Board of Directors and UNC HCS are focused on a collaboration that would provide opportunities to enhance Pardee’s current clinical services and develop additional services that meet the needs of the people in Henderson County.š As well, there may be cost savings that are developed across both organizations. The structure of this relationship is yet to be determined, but the sale of Pardee Hospital is not a consideration.

“The Henderson County Board of Commissioners initiated these discussions with UNC HCSš in concert with the Pardee Board. We are pleased that the Pardee Board is acting on our joint discussions to explore an enhanced relationship with UNC Health Care.š The entire Board of Commissioners is very excited about both the short-term and long-term possibilities this potential partnership brings to the citizens of our county,” stated Michael Edney, Chairman, Henderson County Board of Commissioners.

William Lapsley, Pardee Hospital Board Chair commented, “It’s the Board’s desire to support our growing population and their need for quality healthcare services. These discussions explore that initiative. Our mission, as a locally owned, locally governed hospital is to look forward to meet the healthcare needs of the residents who utilize Pardee Hospital.” Lapsley continued, “The residents of Henderson County who have supported Pardee Hospital for the last 57 years have seen the hospital’s growth in services that are important to the people of Henderson County.š We want to continue those quality services in partnership with physicians and area providers. We will keep all our stakeholders updated on a periodic basis of the discussions with UNC Health Care.”

An affiliation between Pardee Hospital and UNC HCS may improve access and delivery of medical services in Henderson County and enhance medical education programs currently in place in Western North Carolina.

Pardee Hospital is the only hospital owned by the residents of Henderson County. Founded in 1953, it is a not-for-profit hospital licensed for 222 acute care beds and is the second largest employer in Henderson County. The hospital has several locations separate from the main campus, including an adult day services center, a health education center in the Blue Ridge Mall, home care services, a rehab and wellness center, various physician practices, and an urgent care facility.

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Sleep Disorders News

2010-12-09 / Other / 0 Comments

Graymark Healthcare to Focus on Treatment of Sleep Disorders with Completed Sale of Independent Pharmacy Business Assets to Walgreens

OKLAHOMA CITY, Dec. 7, 2010 /PRNewswire-FirstCall/ — Graymark Healthcare, Inc. (Nasdaq: GRMH) has closed the previously announced sale of substantially all the assets of its ApothecaryRx’s retail pharmacy business to Walgreens Co. (NYSE: WAG, Nasdaq: WAG). ApothecaryRx operated 18 pharmacies across five states.

The transaction allows Graymark to focus on its core business of providing comprehensive care for sleep disorders, primarily obstructive sleep apnea, including diagnosis, therapy, and ongoing clinical and product support.

“Millions of Americans suffer from obstructive sleep apnea, and many aren’t aware they have a problem or that treatment is available in their communities,” said Stanton Nelson, chairman and CEO of Graymark Healthcare. “As a pure-play sleep disorders company focused primarily on obstructive sleep apnea, we believe Graymark is better able to help people sleep better.”

Graymark launched the nation’s first comprehensive care model for patients with obstructive sleep apnea in 2009 and has grown into one of the nation’s largest aggregators of sleep therapy providers.

“Given our substantially improved balance sheet as a result of this sale, we are ideally positioned to execute on our plans to grow through the acquisition of treatment centers, as well as through developing alliances with hospitals and other health care providers,” added Nelson. “The rapidly growing sleep apnea marketplace offers us an opportunity for significant growth and margin expansion.”

The sale to Walgreens was comprised of substantially all of the assets of ApothecaryRx for $25.5 million, plus approximately $3.8 million for inventory. Graymark expects to realize net proceeds of approximately $33 million from the completed divestiture, including collection of retained accounts receivable, and proceeds from the liquidation of remaining ApothecaryRx assets.

The Healthcare Investment Banking Group of Morgan Joseph LLC served as the financial advisor to Graymark in this transaction, with Greenberg Traurig LLP and Commercial Law Group, P.C. serving as Graymark’s legal advisors.

About Graymark Healthcare

Graymark Healthcare, Inc. is the nation’s second largest provider of sleep medicine diagnosis and treatment. Graymark owns and operates diagnostic sleep centers that treat a wide range of sleep disorders, and operates a medical equipment supply company that provides disposable and durable medical equipment. For more information, please visit www.graymarkhealthcare.com.

This press release may contain forward-looking statements that are based on the company’s current expectations, forecasts and assumptions. Forward-looking statements involve risks and uncertainties that could cause actual outcomes and results to differ materially from the company’s expectations, forecasts and assumptions. These risks and uncertainties include risks and uncertainties not in the control of the company, including, without limitation, the current economic climate and other risks and uncertainties, including those enumerated and described in the company’s filings with the Securities and Exchange Commission, which are available on the SEC’s Web site (www.sec.gov). Unless otherwise required by law, the company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Weird Things That Happen When We Fall Asleep: REM Behavior Disorder

Recently, on the NPR show “This American Life,” comedian Mike Birbiglia talked about how he nearly killed himself while he slept—more than once. It seems that he has a disorder called REM Behavior Disorder, which makes a person act out his dreams. Normally the body is paralyzed (or nearly so) during sleep so this sort of thing doesn’t happen. But, in people with REM Behavior Disorder, the “sleep paralysis” mechanism fails.

As a comedian, Birbiglia makes jokes about climbing high onto a bookcase in his sleep——in his dream he was on a podium receiving an Olympic medal for vacuuming—and then falling off of it. Another time, he jumped through a second-story hotel window in his underwear “to escape a missile.” Since he survived, we can marvel (and, perhaps, laugh) at this escapade, but I’m guessing these events weren’t funny at the time—he ended up bruised and needing emergency medical attention.

REM Behavior Disorder is one of several uncommon sleep disorders–it affects about half of 1% of the population. Maybe it’s the rareness of these “extreme” sleep behaviors that makes them so interesting. Or maybe it’s just that these sleep-related experiences are so bizarre. They’re certainly not the usual series of events we anticipate when lying down for a good night’s sleep. In any case, here’s a brief roundup of some interesting—and, often, frightening—sleep disorders.

REM Behavior Disorder

The name REM Behavior Disorder comes from the stage of sleep when the eyes move rapidly (Rapid Eye Movement), and dreaming occurs. In most people, the brain is extremely active during REM sleep, but the body is paralyzed, except for some occasional muscle twitches. And, of course, the muscles needed to keep you alive—the breathing muscles and the heart – are still active and so are your eyes. While the body is quiet, the brain is racing along. Although most of us are blissfully unaware, deep sleep is actually a time of active brain activity.

REM Behavior Disorder was first described in cats and was only recently reported in humans—the first human case was described in 1986. Scientists don’t know why the bodies of people with REM Behavior Disorder aren’t paralyzed as they should be during REM sleep. Experts believe the acting out of dreams is a problem with neurotransmitters (chemicals in the brain), but different studies point to different neurotransmitters. It may be that different neurotransmitters are to blame in different people.

REM Behavior Disorder may be accompanied by a number of brain diseases including Parkinson’s disease, dementia, and multiple system atrophy (a degenerative brain disease). In nearly half of cases, REM Behavior Disorder may be related to alcohol withdrawal or withdrawal from a sedative or antidepressant medication. But it can occur for no apparent reason in otherwise healthy people.

There are many medications that can help people with REM Behavior Disorder. However, since so few people are affected by the disorder, we don’t have large, high quality studies to tell us which medications are best. As a result, it can take some trial and error to find a medication that’s right for an individual with this condition. A sleep specialist can help.

It’s important to make the bedroom of people with REM Behavior Disorder as safe as possible until they can get their nighttime behavior under control. It may be a good idea to put the mattress directly on the floor, pad the corners of furniture in the room, remove anything fragile or dangerous from the room, and have bed partners sleep in another room.

Sleep paralysis

In a way, sleep paralysis is the opposite problem of REM Behavior Disorder: instead of acting out dreams while asleep, a person with sleep paralysis is awake but cannot move. It’s common, affecting up to 40% of the population. It can be associated with sleep deprivation, other sleep disorders, psychological stress, or certain medications. Fortunately, it lasts only a few seconds or minutes and usually requires no treatment. Still, it can be scary.

The teenager who sleeps for 10 days

Trying to wake Louisa during one of her episodes is difficult
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While most teenagers struggle to get out of bed in a morning, Louisa Ball might take 10 days to fully wake from her slumber, due to a very rare neurological disorder. So what’s it like living with Kleine-Levin Syndrome?

Louisa has slept through holidays, friends’ birthdays and half of her GCSEs.

In 2008, aged 14, she had been suffering from flu-like symptoms. She was at her school in Sussex when she started nodding off in class and behaving strangely.

“I didn’t know what I was doing, what I was saying, everyone thought ‘hey this isn’t right,'” she recalls.

“I was hallucinating and after that I don’t remember anything. All of a sudden it just went blank and I just slept for 10 days. I woke up and I was fine again.”

Her parents Rick and Lottie watched their daughter becoming fidgety and with unusual facial expressions as she sank into sleep. The first time was a frightening experience for them, although Louisa herself says she wasn’t scared by the episode, more puzzled.

“It was really weird, no one knew what was wrong, we just thought it wasn’t going to happen again. And then four weeks later it happened again.”

She was finally diagnosed with Kleine-Levin Syndrome (KLS). There is no known cause or cure but Louisa says it was good to know what it was and that it wasn’t life threatening.

The average time it takes to diagnose the condition is four years, because there is no test and so it requires a process of elimination of other disorders.

The disease was named after Willi Kleine, a neurologist from Frankfurt, and Max Levin, a psychiatrist from New York, who identified patients with similar symptoms in 1925 and 1936.

Louisa is unusual as KLS usually affects teenage boys, who can also exhibit hypersexuality and inappropriate behaviour.

As well as excessive sleeping, symptoms include behaviour changes, irritability, feeling in a dream-like state and binge eating, symptoms that can be mistaken for normal teenage behaviour. There are no drugs that have conclusively shown to alleviate symptoms.

‘No dreams’

People with the sleep disorder narcolepsy fall asleep immediately, but people with KLS might sleep more and more over a number of days before falling into sleep mode.

Louisa says she remembers very little when she wakes up from an episode: “It’s just blank – no dreams. Now I’ll remember a lot more that’s gone on. Before I wouldn’t remember anything at all. My dad thinks my brain is learning to cope with it more.”

So how do you deal with a disorder that takes over your life so much?

It nearly ruined Louisa’s career ambitions, because she slept through most of her GCSEs but her college allowed her to enrol and she is studying sport performance and excellence, with dreams of being a dancer.

At first, her school teachers didn’t understand, she says. “They’d give work to my brother for me to do and when I went back to school they expected me to have done it but I’d have slept for 10 days.”

Some people with KLS have complained they have lost their friends because they suddenly disappear for weeks on end but Louisa has a close knit group of girlfriends. Some even visit her when she’s sleeping, just to check she’s ok.

When she wakes up, it takes her a few days to fully come round, and her body is quite stiff so her dancing is affected for while.

“I’ve never really got upset about it but I sometimes do think ‘why me’, because I’ve always been a normal healthy person. But all of a sudden it happened and there’s no reason why it happened and that sometimes frustrates me.

“But I’ve got used to it now and learnt to live with it. I’m a special kid.”

The change in behaviour before and during a sleep episode is one of the most upsetting things for Louisa’s parents, who take it in turns to remain with her. Doctors have told the family it’s crucial to wake Louisa once a day to feed her and get her to the bathroom.

But Lottie admits it can take a while to get her to come round. “I’ve tried before to literally force her to wake up but she just starts swearing and gets so agitated and aggressive.”

After watching a video the family made of her while sleeping, Louisa says: “I look scary, it doesn’t look like me, it’s like I’m on drugs.”

Frustrated by the lack of information in the UK, Louisa was taken by her parents to the Hospital Pitié-Salpétrière in Paris, where researchers are looking into whether it is caused by a defective gene.

Many sufferers have abnormalities in their temporal lobe, the area of the brain involved in behaviour and memory. A scan of Louisa’s brain function revealed she does have abnormalities in her frontal lobe but there are no signs that this has affected her behaviour or memory.

The good news is the disease can also disappear just as suddenly as it came on. This normally happens after 10 to 15 years.

But Louisa is currently going through a good period. She was out doing Christmas shopping with her best friend this week and has not had an episode in 13 weeks. A few weeks ago she won yet another dance competition.

“It’s almost as if I’ve forgotten about it because I haven’t had one in so long.”

Louisa’s parents, however, are still watching her constantly for signs she could be heading into a sleep state.

“It’s weird – now I’ve left school I haven’t actually had an episode, they probably think I was faking it,” she jokes.

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Sciatica News and Treatment

2010-10-22 / Other / 0 Comments

Do You Have Suggestions For “Sciatica”?

By Lewis G. Maharam, MD, FACSM

Hi,

I am registered for the P.F. Chang’s Rock ‘n’ Roll Arizona Half Marathon on Jan. 16 and have had a very challenging bout of sciatica for months. After physical therapy, acupuncture, chiropractic and traditional medicine helps, I remain stifled in training with longer distance efforts at walk, run. I was not a true athlete to start and this is a real disappointment to me. Do you have any suggestions? Recommendations from your knowledge, expertise? I do not really want to pull out, but I am afraid that my performance will be impaired radically.

Thank you for your reply to this appeal.

Roseanne K.

Dear Roseanne:

Your letter was forwarded to me as Medical Director of all the Rock ‘n’ Roll Marathons. I’m sorry to hear of your issues.

I hear this same question all the time in my practice of sports medicine in NYC! Runners are the most sophisticated medical consumers I know, but they’re still getting — and buying — one of the big, bogus diagnoses of all time: “sciatica.” It’s bogus because it somehow makes you feel good without actually revealing a thing about what’s wrong. Sciatica is a symptom, not a diagnosis!

Why, then, do some physicians simply stick “sciatica” onto so many athletes like a diagnostic Post-it, give them a couple of generic exercises, and send them away? Because, frankly, a lot of back patients don’t get better. They return repeatedly with the same complaint, and the doctor eventually begins to wonder whether they even want to recover, overlooking the fact that it could be the treatment that’s not hitting the target. A more refined answer takes time and effort, whereas a “sciatica” diagnosis is an easy way of sending the patient away happy. (Plus, “sciatica” is a reimbursable diagnosis code.)

That tingling or painful sensation going down your leg could be caused by any number of things happening to any number of nerves way “upstream.” Degenerative disk disease, which we all get as we age, can let a vertebra settle onto a nerve and irritate or pinch it. A facet joint at the back of a vertebra can get out of alignment. A strained back muscle might go into spasm and painfully squeeze a nearby nerve or nerve sheathe. Even running with a leg-length discrepancy, the most common back pain culprit among my patients, can cause “sciatica”.

The list goes on and on, but fortunately these are not unfathomable mysteries. They can, and will, be found by someone determined to get to the bottom of a patient’s back pain because we now have the diagnostic tools to do that. And each cause has a specific treatment.

If “sciatica” is as far as you can get with your physician, consult someone else. You don’t want a Post-it — you want a probe. I’m sorry I can’t tell you that “you can run” without the real diagnosis. Please write back when you do get that real diagnosis, and let us know how things turned out. Good luck.

Enjoy the ride.

Dr. Lewis G. Maharam is the world’s premier running physician. He is medical director of Competitor Group’s Rock ‘n’ Roll Marathon series and The Leukemia & Lymphoma Society’s Team in Training program. He also serves as Chairman of the Board of Governors, International Marathon Medical Directors Association. Dr. Maharam’s column can be followed in Competitor Magazine and on his Facebook page: Running Doc

Any questions you may want answered by Dr. Maharam in future columns should be written in the comments below. Feel free to add your comments about your experience with the above situation as well. Dialogue is great and we look forward to expanding that in the comments section of this blog.

What to do about sciatica pain

Sciatica is an often-used term in the medical field and many of you reading this will have experienced that awful leg pain caused by a ‘pinched’ nerve in the lower back. Sciatica refers to the pain that radiates down the back of your leg along the path of the sciatic nerve. The sciatic nerve is the largest nerve in the body and originates from the spinal nerves of the lower five vertebrae in the spine.

As you go down each vertebrae of your spine from your neck to your tailbone, there are nerves that branch off the spinal cord and then exit your spine between each vertebrae. There are 31 matching pairs of spinal nerves supplying the left and right side of your body. Irritation of a spinal nerve at any level can have a number of consequences including: numbness, tingling, pins and needles, weakness and pain. When the nerves in the lower back area are irritated, sciatica is often the result.

Nerves are one of the most sensitive tissues in our body and they require a large amount of continuous blood flow to them to maintain health. All of our nerves added together account for only two per cent of our total body mass, however nerves use approximately 20 per cent of our blood flow, a full 10 times the amount you might expect. Because of this high demand for blood if there is any disruption of blood flow to the nerves as they exit the spine, the end result is very often pain.

Compression or inflammation of a spinal nerve is typically caused by either a bulging disc (disc herniation), or by compression from the deep spinal muscles. A disc rupture or herniation occurs when the tough, outer ring of the disc breaks open or cracks, allowing the inner fluid material to push outwards causing the disc to bulge. This bulging causes an inflammatory reaction that often leads to irritation of the nerve, resulting in pain. In the majority of the cases the disc bulge does not actually press on the nerve, however the resulting inflammation causes protective muscle tightening and joint stiffness to occur. Very often it is this resultant tightening of the muscles and spinal joints that prevents blood flow from ‘washing’ out the inflammation around the nerves. If this stiffness can be reversed, the body is in many cases able to heal itself and the sciatica pain goes away.

Although the pain from sciatica often comes on suddenly, the reality is that in most cases it is the result of years of accumulated micro-traumas to the spine. The stress and micro-traumas created by the constant motion of our spine and by poor postures, leads to ‘wear and tear’ on our discs, spinal joints and ligaments. Labour jobs and traumas such as motor vehicle accidents can also create early wearing down of the spine.

Treatment of sciatica focuses on improving the blood flow to the nerves by increasing the flexibility of the spine as well as releasing the deep muscle tension in the low back that often creates extra pressure on the exiting nerves. As soon as the mobility improves in the spine, the next step is often to strengthen the core muscles of the abdomen and lower back in order to prevent recurrence. Most cases of sciatica can be treated and do not require surgery. If you are suffering from sciatica type pain, consult your physiotherapist or medical doctor as it usually can be treated and shouldn’t be something you have to live with.

Check-up: Lumbar epidural steroid injections

With a recent diagnosis of sciatica, my GP referred me on to a specialist. She has recommendedan epidural steroid injection into my back. Can you explain what this is?

Sciatic pain is usually caused by irritation or compression of one or more spinal nerve roots in the lumbar spine. Although this can cause pain in the buttocks and down the leg, the problem is actually in the back.

For sciatic pain, an epidural steroid injection will be injected into the lumbar (lower back) area. A mixture of a dilute local anaesthetic and a long-acting steroid is injected into the epidural space that surrounds the spinal cord and nerve roots.

The aim of the treatment is to help reduce inflammation in that area.

What does the procedure involve?

Before the procedure, a small cannula will be placed in the back of your hand, through which a short-acting sedative will be given. This will make you feel relaxed. You may also be given oxygen during the procedure.

Lying, curled on your side, local anaesthetic will be used to numb the skin at the injection site and to numb the space between the lumbar vertebrae. An epidural needle is then passed through the skin into the epidural space with the aid of an X-ray image.

The anaesthetic and steroid mixture is injected slowly into the epidural space and you may feel a build-up of pressure in your back while this is done.

For a couple of hours after the injection, you will be positioned on your side, with the affected side down, to encourage the epidural medication solution to reach the affected area.

Most people can be discharged – with supervision – after a number of hours, or when all vital signs are stable.

What about side effects?

Soreness and bruising at the injection site, which typically settles after a few days, is common after epidural injection.

Less common side effects can include bleeding and haemorrhage into the epidural space or infection leading to an epidural abscess.

The spinal cord and nerves may be damaged by the needle, while puncture of the dural membrane can occur if the epidural needle is put in too far. Severe allergic reaction can develop due to the injection solution.

Epileptic seizures may occur and, in rare cases, numbness in the whole body can happen due to the local anaesthetic entering the spinal fluid.

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Alternative Medicine Today

2010-10-08 / Other / 0 Comments

Alternative and complementary therapies abound for breast cancer patients

That’s because the clinical and professional herbalist and certified flower essence practitioner who works out of her home in West Asheville believes more and more people are looking for alternatives to conventional Western medicine.

“Women have been using herbs on themselves for thousands of years,” Frezza said. “Western medicine has its place and can be used in conjunction with alternatives. A lot of people are really getting tired of pharmaceuticals.”

Frezza works in a field that’s getting more and more attention as the cost of conventional treatments continues to rise, and as research into a variety of alternatives yields more confirmed results. At the forefront of that research is the National Center for Complementary and Alternative Medicine. It’s one of the 27 centers and institutes that makes up the National Institutes of Health and is the federal government’s lead agency for scientific research on complementary and alternative medicine.

According to the center, a 2007 National Health Interview Survey found that about 38 percent of adults use the therapies. Complementary medicine is defined as medicine used in conjunction with conventional medicine, while alternative medicine is used in place of conventional medicine.

There are a number of ongoing research studies and clinic trials. For example, there are ongoing trials to study the effectiveness of tai chi and a cardiovascular exercise fitness program in improving the physical fitness and reduction of stress in adult survivors of solid-tumor cancers.

Another study is examining the effectiveness of the combination of mistletoe extract and gemcitabine in patients with solid tumor cancers. The FDA has approved mistletoe extract for use in cancer treatment studies, and mistletoe extract has been used either alone or together with conventional anti-cancer drugs to treat cancer in thousands of patients in Europe.

Frezza says she educates her clients on recent studies, points to resources such as a PubMed, a service of the National Library of Medicine that includes brief summaries of articles from scientific and medical journals, and can explain the folk history of plant medicine.

For someone with breast cancer, Frezza said that although every case is different, she might suggest the use of red clover or violet oil. She also said she would target the physical well-being of a client, as well as their emotional health and their energy level.

“I like to think of myself as a spokesperson for plants,” Frezza said. “What I’m really doing is helping people help themselves.”

Alternative Therapies for Ulcerative Colitis

People with IBD are very likely to have tried complementary and alternative medicine (CAM) to treat their symptoms. There are several reasons for this, not the least of which is that many of the prescription medications for IBD carry unwanted side effects. But CAM isn’t always the easiest route to take, either, because what worked for one person may not work for another, and just because something is marketed to treat IBD doesn’t mean that it will actually help. In fact, for some CAM, there’s not much evidence to recommend their use. Some of the CAM therapies associated with ulcerative colitis include: Aloe Vera
Boswellia
Butyrate
Licorice Root
Omega-3 Fatty Acids
Slippery Elm

Alternative Biomedical Treatments for Autism: How Good Is the Evidence?

Parents who research treatments for autism are confronted with a bewildering array of options, almost all of which have never been tested for safety and effectiveness. Organizations like The Cochrane Collaboration, which reviews the quality of evidence for medical treatments, are putting more effort into evaluating popular alternative treatments.

So far, the most comprehensive review of alternative autism treatments comes from two pediatricians: Susan Hyman of the University of Rochester School of Medicine Golisano Children’s Hospital at Strong and Susan Levy, a clinical professor of pediatrics at the University of Pennsylvania School of Medicine and The Children’s Hospital of Philadelphia. Their 2008 analysis gave each treatment a letter grade for the quality of the research conducted up to that point; the mark, however, is not a ranking of the treatment’s safety or effectiveness.

The two pediatricians based the grades on the amount of testing done on the treatments, which in most cases was skimpy at best. Research that got an “A” grade included randomized control trials, the gold standard for medical research, and meta-analyses, which compare research from different labs. A “B” went to treatments that had been studied in “well-designed controlled and uncontrolled trials,” according to Hyman. The “C” grades, the lowest category (there were no “D”s or “F”s), were based on case reports, theories and anecdotes, which are not considered acceptable for mainstream medical research.

Research on just one treatment, secretin, was good enough to earn an A. In short, there is a lot more work that needs to be done toward testing popular alternative treatments and getting more potential treatments into development at research institutions and pharmaceutical companies.

Dietary supplements

B6/Mg++—Grade: B

Vitamin B6 and magnesium have been a popular treatment for autism over the past 20 years. The Cochrane Review identified three studies that compared outcomes of B6 and magnesium treatment with those for placebo or no treatment, but just 28 subjects were treated altogether. One study found no improvements; another reported improvement in IQ and social behaviors. But all the studies suffered methodological weaknesses aside from the small sample size.

DMG—Grade: B

Dimethylglycine (DMG), an antioxidant and derivative of the amino acid glycine, is marketed as an immune system booster. Two small double-blind studies of DMG found it had no effect on autism symptoms.

Melatonin—Grade: B

Melatonin is a hormone produced by the pineal gland that regulates sleep. Melatonin supplements are popular for self-treating insomnia or jet lag. Many people with autism-spectrum disorders report sleeping problems, and at least one study has found improvements in falling asleep and staying asleep.

Vitamin C—Grade: B

Vitamin C, an antioxidant, is often part of vitamin supplements given to children with autism. One study reported less repetitive behavior in a double-blind, placebo-controlled trial of vitamin C in 18 children with autism.

Amino Acids—Grade: C; L-Carnosine—Grade: B

Neurotransmitter abnormalities have long been a focus of autism research. Some amino acids act as neurotransmitters or prompt their production, so amino acids like tryptophan have been tried as alternative treatments. No trials have studied the benefits of supplementation with tryptophan, taurine, lysine or GABA. L-carnosine, a molecule made of two amino acids that has antioxidant properties, is marketed as an anti-aging remedy. One double-blind, placebo-controlled trial of L-carnosine in 31 children with autism found improved expressive and receptive vocabulary.

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