Archive for August, 2009

New Technology from Purdue Helps Parkinson’s Patients Speak Louder

Parkinson’s affects 1.5 million people in the United States and is one of the most common degenerative neurological diseases. About 89 percent of those with Parkinson’s have voice-related change, which is related to how loudly they speak, and about 45 percent have speech-related change, or how clearly they speak. Researchers have developed a new technology that helps Parkinson’s patients overcome the tendency to speak too quietly by playing a recording of ambient sound, which resembles the noisy chatter of a restaurant full of patrons. “People with Parkinson’s disease commonly have voice and speech problems,” said Jessica Huber, an associate professor in Purdue’s Department of Speech, Language and Hearing Sciences. “At some point in their disease they will have some form of voice or speech disorder that generally occurs a little later in the disease.”

“A major therapy is to get people to speak louder, which also may cause them to articulate more clearly,” Huber said.

The most common therapy, the Lee Silverman voice treatment program, trains patients to speak louder in one-hour sessions four days a week for a month.

“Some Parkinson’s patients do great with this approach, but others do not,” Huber said. “They forget to keep speaking louder the minute they have left the therapy room. Lee Silverman tends to work less for people with later stages of disease or those who have some cognitive decline. So I wanted to know whether there was an easier way to cue people during therapy, rather than telling them, ‘Try to be twice as loud,’ or ‘Try to focus on this sound meter and achieve this loudness.’”

Huber used a new approach: Patients were asked to speak louder while a recording of background “multitalker babble noise” was played. The noise is essentially the sound of a restaurant full of patrons, but without clattering silverware and clinking glasses.

The background sound elicits a well-known phenomenon called the Lombard effect, a reflex in which people automatically speak louder in the presence of background sound.

“You go into a loud room at a party and you talk louder without even realizing it,” Huber said. “We’ve all had the experience where the room suddenly gets quiet and you’re still shouting but you didn’t know you were.”

Huber created a new electronic technology using this principle. The voice-activated device automatically plays the background babble when the person begins to speak.

A critical part of the research is to integrate the voice-detection sensor, called an accelerometer, developed in work led by biomedical engineering doctoral students Matias Zanartu and Julio C. Ho and biomedical engineering professor George Wodicka, head of Purdue’s Weldon School of Biomedical Engineering.

“This sensor is crucial because it is essential that the background babble noise only turn on when the subject talks,” Huber said.

The device prototype was built by engineering resources manager Jim Jones and senior research engineer Kirk Foster, both in the Weldon School. An earlier prototype had been built by Scott Kepner, manager of technical services, and Derek Tully, assistant manager of technical services, both in the Department of Speech, Language and Hearing Sciences.

Six patients wore the portable system for eight weeks. Data collected showed the system effectively prompts Parkinson’s patients to speak louder and more clearly.

“Their speech changes significantly,” said Huber, who is working with Meghan Darling, a doctoral student in Speech, Language and Hearing Sciences. “There have been times where I have called patients and they’ve had the device on and I didn’t really recognize them. And these are patients I’ve known for a long time.”

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Kids’ Menu Falls Behind the Times

Today’s kids’ menus are so…last year. Mintel Menu Insights, which tracks restaurant menu trends, says the average kids’ menu doesn’t offer enough variety or healthy food, even as parents, kids and chefs alike call out for better options.

Analyzing kids’ menus from 2005 to the present, Mintel Menu Insights sees the same clichéd foods repeated year after year. Chicken fingers steadily account for 10% of kids’ menu items, followed by grilled cheese sandwiches, mac & cheese and burgers. Despite increasing health and obesity concerns, other top kids’ menu items include hot dogs, pizza and corn dogs.

Do kids and parents really never tire of the same old thing? Not at all, says Maria Caranfa, RD and director of Mintel Menu Insights. “Our research shows parents want more nutritious options for their kids, and children are open to fruits, veggies and healthier versions of standard fare. The generic kids’ menu really doesn’t meet the needs and desires of today’s families.”

Only three in 10 parents say their children eat healthfully at restaurants. But Mintel found kids will eat fruits and veggies. More than three in four children (77%) are open to ordering foods with vegetables, and six in seven (86%) would order fruit-containing items.

Some restaurants have started toying with healthier menus for kids. Though french fries are still the most common side (offered with 66% of kids’ menu items), fruits and vegetables have risen in popularity (now at 43% and 39%, respectively). Even rice and salad (18% each) are showing up as kids’ side options.

Additionally, more restaurants now use menu descriptors to quantify health. “Fresh” is the top marketing claim on kids’ menus, appearing on 17% of items during Q2 2009. In Q2 2005, only 8% of kids’ menu items carried the “fresh” claim.

“Restaurants dabble in healthier menus for kids, but there’s still significant work to be done,” comments Maria Caranfa. “Health and obesity issues, the popularity of ethnic foods and increased media coverage are creating pressure for revamped kids’ menus. Soon, health and menu variety will be the new standards in kids’ dining.”

Maria Caranfa points out recent innovations in healthier kids’ menu items:

  • Bob Evans: Grilled Chicken Strips with a fresh garden salad
  • Burger King: Fresh Apple Fries
  • Elephant Bar Restaurant: Tropical Citrus Salad with Chicken

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Preteen Immunizations

What are the guidelines for preteen immunizations? Aetna’s internal research shows that parents who receive reminder notices and follow up phone calls from their health plan are statistically more likely to have their teens vaccinated compared with a control group that did not receive proactive outreach. According to the Centers for Disease Control and Prevention (CDC), most teens and preteens have not had all of the recommended vaccinations. None of the target vaccination goals established in the Healthy People 2010 report for this age group are currently being met.

“Even as the health care reform discussion continues, there are steps we can take right now to improve our own health care,” said Lonny Reisman, MD, chief medical officer at Aetna. “One such step is to follow through on evidence-based recommendations for vaccinations. Parents should discuss their child’s immunizations at each doctor’s visit, including yearly checkups and physical exams required for school or sports programs.” Reisman recommends keeping track of immunizations in an electronic personal health record. “A personal health record helps you and your physician keep your family’s immunizations on schedule. It is particularly helpful if you move or change doctors as it can prevent your child from getting duplicate vaccinations.”

To improve preteen vaccination rates, Aetna sends plan members caring for children ages eleven and twelve information on vaccinations. The reminder notices are available in English and Spanish and include an immunization schedule listing vaccines children need before age thirteen and a list of credible resources members can consult for more information.

Vaccines recommended for 11- and 12- year-olds

Tetanus, diphtheria and acellular pertussis (Tdap)
Protects against: tetanus (lockjaw) and diphtheria and whooping cough
1 shot — between ages 11 and 12 years old

Meningococcal (MCV4)
Protects against meningitis
1 shot — between ages 11 and 12 years old

Human papillomavirus (HPV)
Protects against cervical cancer (for females only)
3 shots — first shot between ages 11 and 12 years old;
second shot 2 months after the first shot; and the third shot 6 months after the first shot

Varicella (chicken pox)
Protects against chicken pox
1 additional shot
(Second shot is recommended for anyone who previously received only one dose)

Seasonal influenza vaccine
Protects against the seasonal flu
One shot (or nasal spray) each flu season

Special note: H1N1 influenza vaccine
This year, persons between the ages of 6 months through 24 years are among the priority groups recommended for protection against H1N1 (swine) flu. It is currently not known whether one or two doses of the vaccine will be needed.

Based on recommendations by the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) as of 4/30/09.

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What Women Don’t Know Could Kill Them: Every 60 Seconds a Woman Dies of Heart Disease

Stop ten women on the street and ask them what their biggest health risk is, and, chances are, more than half of them would answer “breast cancer.” They would be wrong.  Taking the life of one woman every minute, heart disease is the leading cause of death of women in America. Unfortunately, most women put their own needs behind the needs of their families, rarely considering the risks and dangers of this devastating disease.

To address such widespread lack of awareness, The Main Line Health Heart Center announced the launch of its Women’s Heart Initiative, a one-of-a-kind team of physicians and clinical staff in southeast Pennsylvania, designed specifically to empower women in taking charge of their cardiovascular health.

Unlike other women’s cardiovascular initiatives, the Women’s Heart Initiative features a unique difference – it includes focused, highly structured medical training for both physicians and nurses that will help them recognize and assess the often overlooked disease. In this way, it is slated to become a leading resource not only for women, but also for clinicians who aim to further their understanding of cardiovascular disease and how it affects women.

Providing specialized attention and healthcare, the Women’s Heart Initiative educates women and their physicians to talk openly about the warning signs of heart disease. The Initiative provides continuing education, wellness outreach, risk assessment and physician referrals for all women.

Offering health screenings, workshops and other heart healthy events, the Initiative includes a team of cardiologists, heart surgeons, nurses and other highly trained healthcare professionals dedicated to delivering superlative care and understanding the distinct needs of women.

Women experience heart disease warning signs differently than men, and, as a result, are often diagnosed when the disease is in an advanced stage.

Every woman needs to be aware of her risk factors for heart disease and how she may experience surprisingly different heart attack symptoms than the “classic” symptoms many men exhibit. Atypical symptoms in women include:

  • Unusual fatigue
  • Shortness of breath, difficulty breathing
  • Dizziness, nausea, unexplained anxiety

Leaders in their field, the co-directors of the Women’s Heart Initiative include three physicians passionate about empowering women with the tools, knowledge and resources to defeat heart disease:

  • Dr. Maribel Hernandez, Lankenau Hospital cardiologist/electrophysiologist:
    Having attended medical school at Stanford University and completing her residency at New England Deaconess Hospital, Harvard Medical School, her areas of clinical interest now include arrhythmias and women’s heart disease.
  • Dr. Herman Movsowitz, Paoli Hospital cardiologist:
    He attended medical school at the University of Cape Town Medical School in South Africa and completed his residency at Brigham and Women’s Hospital, Harvard Medical School. Subsequently, he completed his fellowship training at Albert Einstein Medical Center and Massachusetts General Hospital.
  • Dr. Leslie Poor, Bryn Mawr Hospital cardiologist:
    She attended medical school at the Medical College of Pennsylvania and completed her residency at Abington Memorial Hospital and her cardiology fellowship at Lankenau Hospital. Dr. Poor’s areas of clinical interest include prevention of cardiovascular and coronary artery disease and heart disease in women.

“Although heart disease is the leading cause of death among women in our country, women often ignore the warning signs of a heart attack because they frequently differ from the symptoms experienced by men,” said Dr. Maribel Hernandez. “We created the Heart Initiative to address the urgent need for women to access education, tools and resources tailored to meet their distinct heart health needs.”

The Initiative aims to create supportive relationships between women and their physicians in order to promote lifestyle modification and cardiovascular risk factor reduction, while promoting the ideals of Learn, Act, Live:

  • Learn: Learn more about heart health, the risks of heart disease and how to live a healthier lifestyle. Share this knowledge with other women in your life – sisters, mothers, daughters and friends – so that they too are empowered.
  • Act: Make choices that reflect a commitment to heart health – go to a health screening, attend educational programs, learn to cook heart-healthy recipes, make your first priority you.
  • Live: Live your life to the fullest, knowing that if you ever need medical help, the Women’s Heart Initiative is right around the corner – providing the region’s best doctors, surgeons and cardiovascular health programs tailored exclusively for women.

The Main Line Health Heart Center will officially launch its Women’s Heart Initiative at a kick-off event, held Thursday, November 5th from 5:30-8:30 p.m. at the Villanova Conference Center. Women are invited to a night of elegance that will include a gourmet heart-healthy dinner, heart health screenings, boutique vendors and a panel discussion featuring the Women’s Heart Initiative Co-Directors. Keynote speaker Kathy Kastan, author of From the Heart: A Woman’s Guide to Living Well with Heart Disease and the Women’s All Heart Family Cookbook, will discuss her own battle with heart disease and the road she took to getting diagnosed and properly treated.

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Stanford Professor Sequences His Entire Genome at Low Cost, with Small Team

The first few times that scientists mapped out all the DNA in a human being in 2001, each effort cost hundreds of millions of dollars and involved more than 250 people. Even last year, when the lowest reported cost was $250,000, genome sequencing still required almost 200 people. In a paper to be published online Aug. 9 by Nature Biotechnology, a Stanford University professor reports sequencing his entire genome for less than $50,000 and with a team of just two other people.

In other words, a task that used to cost as much as a Boeing 747 airplane and required a team of people that would fill half the plane, now costs as much as a mid-priced luxury sedan and the personnel would fill only half of that car.

“This is the first demonstration that you don’t need a genome center to sequence a human genome,” said Stephen Quake, PhD, professor of bioengineering. “It’s really democratizing the fruits of the genome revolution and saying that anybody can play in this game.”

There are at least two reasons why lowering the cost and effort required to sequence all the genetic information of individuals is important. The more examples scientists have of the whole human genetic code, the more they can discern about how specific genes and mutations result in the traits that make us all different, the diseases that plague us and our response to medicines. As that understanding increases and costs drop, doctors could then sequence their patients’ genomes and provide “personalized medicine” in which prevention and treatment of disease would be informed by the patient’s exact genetic profile.

“This can now be done in one lab, with one machine, at a modest cost,” said Quake, the Lee Otterson Professor in the School of Engineering and a member of Stanford’s Cancer Center. “It’s going to unleash an enormous amount of creativity and really broaden the field.”

Quake’s genome, one of less than a dozen sequenced so far because of the cost and resources needed, is now available to researchers worldwide. Quake’s colleagues at Stanford’s School of Medicine have been looking through it and sometimes examining Quake himself, mining the data for interesting connections between what they can observe about him, his DNA and his family history.

“Some of the doctors are starting to poke and prod me to see how they can couple my genome with medicine,” he said.

Simpler sequencing

To sequence his genome, Quake’s team used a commercially available, refrigerator-sized instrument called the Helicos Biosciences SMS Heliscope. Quake, who pioneered the underlying technology in 2003, is a co-founder of the Cambridge, Mass.-based company and chairs its scientific advisory board.

The technology—the SMS in the instrument’s name—is called single molecule sequencing. While many techniques require generating thousands of copies of a subject’s DNA, the single molecule technique does not, reducing the cost and effort involved. Instead, the technique requires chopping the 3 billion or so fundamental units of DNA (called bases) into strands about 30 bases long. The four bases in DNA are adenine (abbreviated A), cytosine (C), guanine (G), and thymine (T).

Each base of DNA matches with a specific other base: For example, T only matches with A. The machine captures each of the millions of strands on a specially treated glass plate, holds them there and washes successive waves of fluorescently labeled “letters” over the plate. As each complementary letter sticks next to a strand, the machine can read out the sequence of each strand. A video of the process can be seen on the Web: http://www.helicosbio.com/Technology/TrueSingleMoleculeSequencing/tabid/64/Default.aspx.

Assembling the strands back into a cohesive genome is then done by powerful computers, which compare it to the reference genomes that have been compiled before. The process is akin to assembling an enormous jigsaw puzzle by referring frequently to the picture on the box. The team said the sequencing process took about one month to complete.

Still, several tricky problems had to be solved before the machine could reliably sequence a whole human genome. Quake worked with Norma Neff, a research manager in Quake’s lab, and physics doctoral student Dmitry Pushkarev to write a sophisticated algorithm that would enable them to determine how accurate the process is.

Overall, the genome is 95 percent complete, a rate comparable with other sequenced genomes, the team found. In the paper, the authors are careful to note that all genome-sequencing technologies, including the one they’ve demonstrated, have produced incomplete approximations of the actual genome. Still, it is enough to help produce genuine insights about a person’s traits and health.

A professor’s personal revelations

Quake’s genome has already yielded a few interesting connections between his genetics and his health. One is that he carries a rare mutation associated with a heart disorder; the revelation, he said, sheds light on what members of his family have always wondered with regard to the health of prior generations. The good news, he said, is that he’s also apparently genetically predisposed to respond well to common cholesterol-lowering statin medicines.

Quake said the information has also forced him to take heed of that history. “If you know your uncle had something, you kind of discount that you can get it, but to see you’ve inherited the mutation for that is another matter altogether,” he said.

One amusing “revelation” is that Quake’s code contains a form of a gene that has sometimes been associated with increased disagreeability, he said. The details of the code can be found on the Web at http://www.snpedia.com/index.php/Rs6832769.

“Of course, you don’t need my genome to tell you that,” Quake acknowledged. “My wife could have told you that and certainly the dean could have as well.”

Funding for the research came from the National Science Foundation and from the National Institutes of Health.

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New Study Shows Giant Brain Tumors Can Be Safely and Effectively Removed Through Nasal Route

It’s even worse than being told you have a brain tumor: having a tumor so large, it’s in a category all its own. Giant pituitary adenoma is a so-called “benign” tumor that can cause visual loss and impair many of the body’s most basic functions. But fortunately, even the largest of these giant tumors—which can grow to the size of an egg and invade nearby structures–can be treated effectively using a multimodality approach starting with minimally invasive surgery through the nose, according to a new study at the John Wayne Cancer Institute at Saint John’s Health Center.

Pituitary adenomas are noncancerous tumors of the pituitary, the master gland that rules the endocrine system. Located in the skull base below the brain and behind the nasal cavity, the pituitary secretes powerful hormones that coordinate other glands, controlling such basic functions as growth and development, metabolism, the stress response, sexual function and water balance. Pituitary adenomas arise in about 1 in 1,000 individuals; about 10% are giant adenomas, 4 cm in diameter or larger.

As adenomas enlarge, they can cause pituitary gland failure by cutting off the flow of hormones. Headaches, visual loss and other symptoms may develop slowly over months or years, but can also happen rapidly over just a few hours if there is bleeding into the tumor, called “pituitary apoplexy.” Giant adenomas often grow around the pituitary gland and skull base into areas where critical blood vessels and nerves travel, making complete surgical removal impossible.

Endonasal surgery allows doctors to remove many kinds of brain tumors through a nostril. Reaching the tumor through a natural opening eliminates the need for traditional open-skull surgery (craniotomy) and in experienced hands, creates less trauma, fewer complications and a shorter recovery time. “Patients prefer the idea of a minimally invasive procedure through a natural opening,” said Daniel F. Kelly, MD, Director of Saint John’s Brain Tumor Center, faculty member at the John Wayne Cancer Institute at Saint John’s, and senior author of the study.

The procedure is performed using an operating microscope and an endoscope (a surgical telescope) for highly magnified, high-definition panoramic views of the surgical site. Specialized instruments are passed through the nasal cavity into the skull base to remove the tumor. Like GPS for the brain, a computerized guidance system for surgical navigation completes the high-tech arsenal of modern endonasal skull base surgery.

The new study reviewed 10 years worth of cases involving 51 giant adenoma patients operated on by Dr. Kelly. Their symptoms included progressive visual loss, hormonal problems, tumor bleeding and/or headaches. Using a multimodality approach combining surgery with focused radiation therapy and/or medical therapy, tumors were effectively controlled in 96 percent of patients. Approximately 60 percent required only endonasal surgery, while about 40 percent received surgery plus one or more additional treatments to control residual tumor.

82 percent of 38 patients who had pre-operative visual loss regained some or all of their vision; no patients experienced new visual loss. Also, prior to surgery, 80 percent of the study group had suffered hormonal loss such as low sex hormones (hypogonadism), low thyroid (hypothyroidism) or growth hormone deficiency. Of these patients, nearly half had improved hormonal function after surgery, while only 15 percent showed a deterioration in hormonal function. Ultimately, 75 percent of the 51 patients still required hormone replacement therapy to compensate for the loss of normal pituitary function due to damage caused by the tumor.

“This study shows that endonasal surgery has evolved into a safe and effective treatment of these large and difficult tumors,” Dr. Kelly said. “The vast majority of such tumors can now be removed or effectively debulked through this minimally invasive approach.

“This is particularly welcome because our patients are typically in the prime of life,” Dr. Kelly continued. “To be struck with a deteriorating quality of life related to hormonal loss, headaches or severe visual impairment can be devastating. Fortunately, treating these tumors through a nostril and avoiding a craniotomy is the first step in getting these patients back to health.

“Many patients may need radiation or medical therapy, and long-term hormonal replacement therapy,” Dr. Kelly noted. “But with properly coordinated care, most can look forward to an excellent quality of life.”

Endonasal surgery is a highly specialized area of neurosurgery, and Dr. Kelly urged patients diagnosed with a pituitary adenoma or brain tumor to seek out a center of excellence such as Saint John’s Brain Tumor Center where a high volume of these surgeries are performed, and where patients receive a comprehensive treatment approach including close collaboration with endocrinologists and radiation oncologists.

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Stanford Research Assesses Use of Tamiflu, Relenza to Prevent Flu

Two common anti-influenza drugs—Relenza and Tamiflu—appear equally effective at preventing common flu symptoms when given before infection, say researchers from the Stanford University School of Medicine. However, data is lacking on the effectiveness and safety of the two drugs in vulnerable groups such as the very young and people with compromised immune systems.

The researchers pooled and analyzed the data from seven previously published studies because countries around the world are stockpiling these and other drugs for possible use in the current H1N1 pandemic, as well as for future influenza pandemics. Their results will be published in the Annals of Internal Medicine on Aug. 4.

Together, the studies, published between 1999 and 2007, indicated that individuals treated with either of the drugs were less likely to develop symptomatic influenza (that is, to both test positive for influenza infection in laboratory tests and to experience flu symptoms like fever, headache, muscle aches and coughing) than did those who had received the placebo. Those who received the drugs were, however, no less likely to become infected. The two drugs are best known for their ability to reduce or shorten flu symptoms in already-infected individuals.

Three of the studies investigated the effectiveness or safety of zanamivir, marketed by GlaxoSmithKline as Relenza. The four others explored the effectiveness and safety of oseltamivir, marketed by Roche Pharmaceuticals as Tamiflu. None of the studies compared the two drugs with each other, and all of the studies were funded by pharmaceutical manufacturers. Six of the seven studies included authors that had served as paid consultants of the sponsoring pharmaceutical company.

“These are still high-quality studies,” said Stanford pulmonologist and critical care specialist Nayer Khazeni, MD, the lead author of the study, “but we always like to see research that is independently funded, and we don’t have that in this case.”

Khazeni also added: “There’s a paucity of data for children and people with weakened immune systems even though they’ve been identified by the Department of Health and Human Services and other public health agencies as priority groups in an influenza pandemic. We were hoping to find a much broader distribution of participants in the studies.”

Khazeni and her collaborators selected from nearly 1,900 studies to perform a meta-analysis, a rigorous statistical methodology that can detect statistically or clinically significant results not apparent in smaller, individual studies. They analyzed the results of seven studies comprising more than 7,000 uninfected people who received either of the two drugs for four or more weeks, looking at not just the studies’ results but also at their participants and sponsors. They included only those that were randomized, placebo-controlled and double-blinded.

The researchers estimated that about one case of symptomatic influenza would be prevented for every 25 people who received zanamivir or oseltamivir. Of course, not all of these 25 people would become infected during a normal flu season; the baseline risk for seasonal symptomatic influenza in the seven studies varied between about 6 and 14 percent.

In general, the two drugs appeared to be relatively well-tolerated, although there was an increase in the risk of nausea and vomiting in individuals receiving oseltamivir, which was further increased for those receiving higher-than-recommended preventive doses of oseltamivir. None of the studies enrolled enough people to detect the extremely rare events, including neurological and psychological disorders, which have been associated with these antiviral drugs in certain ethnic and age groups.

Khazeni outlined some of the limitations of the studies: “Nearly all the participants were Caucasian, with the exception of one study of Japanese adults. Children under 12 years of age were not studied, nor were immune-compromised adults or people who had received the live-attenuated influenza virus vaccine.” Live-attenuated vaccine is delivered in the form of an inhaled nasal spray and is increasingly used as an alternative to the more-familiar injected vaccine, especially in children.

Khazeni also noted that although the authors performed a thorough search of studies published in all languages, it is possible that there were studies that did not replicate these findings, but were not published.

Because zanamivir appears to be as effective as oseltamivir in preventing symptoms, it may be useful in combating the increasing number of cases of oseltamivir-resistant influenza observed worldwide. Still, zanamivir is not recommended for people with preexisting lung conditions, as it is inhaled as a powder rather than taken orally.

Although the results suggest that administering the drugs to uninfected people may lessen the chance of symptoms after infection, it is not yet known whether asymptomatically infected people are still infectious. Khazeni, together with another group of colleagues, is currently mathematically modeling a hypothetical influenza pandemic in New York City in which extended-administration of this class of anti-influenza medications, known as neuraminidase inhibitors, is one strategy used to prevent infection.

In addition to Khazeni, other Stanford medical school collaborators on the work include senior research scholar Dena Bravata, MD; post-doctoral fellow Jon-Erik Holty, MD; medical librarian Christopher Stave, MLS; and associate professor Michael Gould, MD. Timothy Uyeki, MD, from the Centers for Disease Control and Prevention also collaborated on the research.

The research was supported by the Agency for Healthcare Research and Quality and by the VA Palo Alto Health Care System.

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How Much Should Cancer Drugs Cost?

Cornell University researchers have found that the true cost of cancer drugs is 30 percent less than a decade ago – once longevity and quality of life are considered, in a study released last week.

The study draws on the experiences of thousands colon cancer patients and treatment decisions by oncologists nationwide, and sheds new light on old assumptions about how to evaluate whether new, costly drugs are ‘worth’ it.

Cornell’s researchers analyzed the real-world treatment data from IntrinsiQ, collected through IntelliDose® clinical software that oncologists use to determine proper chemotherapy dosing. The data digs deeper than a drug’s market share to reveal how it’s used, at what stage, and whether patients receive the full course of treatment – a key sign of efficacy. IntelliDose is the most widely used clinical information system for managing chemotherapy.

“New drugs, like Avastin and Erbitux, are boosting survival rates nearly 100 percent from a decade ago – along with a dramatic drop in complications. Patients taking these new drugs are living longer, and significantly improving their quality of life,” said Jeff Forringer, president of IntrinsiQ, whose data on the drugs patients receive – and in what combination – were a key component of the study’s findings.

Today’s leading drugs for colorectal cancer are typically used in new and constantly evolving combinations, which increases the efficacy of treatments and the options available to more patients.

Patients treated with one popular combination report a mean survival of 23.2 months, compared with the mean survival rate of 12.5 months when patients received just one of the drugs which was the standard of care in 1996. The early treatments were effective for just a small percentage of the patient population. (One of the combinations studied by the Cornell team is bevacizumab (Avastin) + oxaliplatin (Eloxatin) + 5-FU/leucovorin.)

Today’s most commonly prescribed 24-week course of treatment costs an average of $36,000, a dramatic increase over the price of a decade ago. Yet the Cornell study reveals that adjusting cost for quality – accounting for the far greater efficacy of today’s treatments – prices have actually declined.

The Cornell study begins by estimating the financial value that physicians place on eight different attributes of a chemotherapy drug, such as the average number of months that patients live if they are taking the drug, or the percentage of patients that experience a severe side effect. Researchers then create a price index by applying these physician value assessments to changes in drug attributes between 1993 and 2005. Accounting for the changing quality of drugs over this time period and the value physicians assign to the attributes, prices have declined by 30 percent.

The study, “A Quality-Adjusted Price Index for Colorectal Cancer Drugs,” was released last week by the National Bureau of Economic Research (NBER) and is available at http://www.nber.org/papers/w15174.

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Stanford Finds that Two Lines Account for Most Human Embryonic Stem Cell Research

For the past eight years, scientists who wanted to use federal funds for research on human embryonic stem cells had to restrict their studies to 21 cell lines approved by the National Institutes of Health. But an analysis by a researcher at the Stanford University School of Medicine suggests that only two of those lines have been used routinely.

“I was surprised by these results,” said Christopher Scott, director of Stanford’s Program on Stem Cells in Society. “I never imagined that we would find that three-fourths of the requests would be for the same two cell lines.”

On the one hand, the findings raise concerns about the reauthorization process of cell lines under way at the NIH—if these lines are now excluded from federal funding due to ethical considerations, researchers may abandon them, and their previous research, in favor of other lines. On the other, the findings draw attention to the possibility that these two lines may have abnormalities or characteristics that make them not as useful as newer lines.

“Not only are scientists asking for these lines, they are publishing on them,” said Scott, a senior research scholar at Stanford’s Center for Biomedical Ethics. “They have become the reference standards against which new embryonic and iPS cell lines are being compared.” (An iPS cell is an adult cell that has been induced to look and act like a human embryonic stem cell; comparing them with existing embryonic stem cell lines is important, as there is much debate about whether these iPS cells are functionally equivalent to human embryonic stem cells.)

Scott collaborated with researchers from the Mayo Clinic and the University of Michigan to conduct the research, which will be published Aug. 7 in Nature Biotechnology. Together they analyzed the number and timing of requests placed by scientists for human embryonic stem cell lines housed at the two largest stem cell banks in the country: the National Stem Cell Bank at the WiCell Research Institute in Madison, Wisc., and the Harvard Stem Cell Institute in Massachusetts.

Although the National Stem Cell Bank is meant to be the source of all NIH-approved lines, Scott and his colleagues found that at no time have all 21 lines been available for distribution; a maximum of 18 lines were available at the beginning of this year. Two cell lines, known as H1 and H9, made up the majority of requests—941 out of 1,217, or 77 percent, since 1999. One other line, H7, was requested 111 times. In contrast, 13 of the previously approved lines were requested fewer than 10 times in the past decade.

Research on the three most-requested lines from the NSCB is prevalent in the scientific literature: 83 percent of 534 peer-reviewed publications from 1999 to 2008 discussed research on H9, 61 percent on H1 and 24 percent used H7 (the numbers exceed 100 percent because many studies used more than one cell line). In contrast, fewer than 36 percent of the publications used any of the other NSCB-curated cell lines.

Requests for cell lines from the Harvard Stem Cell Institute included a wider selection of lines, but even these were still relatively narrow, the researchers found. The majority of these cell lines were created by Harvard researcher Douglas Melton with private funds. Of the 17 cell lines available since 2004, 234 of 946 requests, or 25 percent, were for one of two lines: HUES1 and HUES9.

Even though the Harvard stem cell lines increase the diversity available to researchers, their impact in the published research has so far been minimal: Only about 3 percent of the peer-reviewed articles included in Scott’s study reported research on the two most popular Harvard lines.

“It could be a first-mover advantage,” said Scott of the researchers’ bias toward just a few lines. “If one group publishes on a particular line, other groups want to replicate and extend that research.” It’s also possible, the authors theorize, that the complex thicket of federal and state restrictions on embryonic stem cell research simply made researchers skittish about branching off into new cell lines.

“The trick will be to avoid this kind of situation with the NIH’s new stem cell registry,” said Scott, referring to the system that the agency will be establishing to ensure that only research on approved lines gets federal funding. Future policies should be designed, he said, to preserve researchers’ ability to continue to work on these well-characterized lines while also encouraging them to plumb the new lines that are expected to become eligible for federal funding under the new regulations. “We’re starting with a very scarce resource, and we have to figure out how to make it high quality.”

The research was supported by the Stanford Institute for Neuro-Innovation and Translational Neurosciences, the National Science Foundation and the National Institutes of Health.

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Student Athletes Perform Better in the Classroom

For many children, the arrival of the back-to-school season means they’ll soon be hitting the field as well as hitting the books. But, for those students currently not involved in a fall sport, Play It Again Sports is offering compelling reasons for why they should become engaged.

“Regular exercise and activity is good for a child’s physical development, but of equal importance are the mental benefits that can be reaped from sports participation as well,” said Pat Quinn, director of Play it Again Sports, which buys and sells quality used sports and fitness equipment. “As children adjust to the academic challenges of a new grade level, involvement in an organized sport can stimulate their brains and boost self-esteem.”

According to Team-Up for Youth, an organization dedicated to strengthening youth and communities through the power of sports, children who participate in sports have better academic outcomes in the classroom. For example, adolescents who engage in moderate physical activity five or more times a week are more likely to achieve an “A” in math and science than their peers.

With sports options such as soccer, lacrosse, field hockey and football, Quinn notes that the fall season offers activities suited for both genders and all ages. For those students looking for more of an individual pursuit, wrestling and cross country are worthwhile considerations.

Quinn does acknowledge that the process of trying out different sports can turn into an expensive endeavor for parents, since they are often required to purchase different gear for each sport. But, Quinn notes that at Play It Again Sports, used gear that is in good condition can be traded in for new merchandise and equipment.

“As children switch between sports and outgrow their gear, parents may find themselves with an attic or a garage filled with perfectly good but unused equipment,” said Quinn. “At Play It Again Sports those items can act as cash when they are traded in for new or gently-used merchandise.”

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