Many chronically ill Americans unable to afford food, medicine

– It’s also important for people to be honest with their doctor if they are unable to afford enough food, since that may affect which medications and dosages are best

– “The idea of tradeoffs that people might make (between buying medications or food) is something we haven’t seen before,”

 

By Allison Bond

NEW YORK          Thu Jan 30, 2014 10:02am EST

A medicine icon.

NEW YORK (Reuters Health) – One in three Americans with a chronic disease such as diabetes, arthritis or high blood pressure has difficulty paying for food, medications or both, according to a new study.

People who had trouble affording food were four times more likely to skip some of their medications due to cost than those who got plenty to eat, researchers found.

“This leads to an obvious tension between ‘milk’ or ‘med,'” said Dr. Niteesh Choudhry, who worked on the study at Brigham and Women’s Hospital in Boston. “If you have a fixed income, should you treat or should you eat?” Continue reading “Many chronically ill Americans unable to afford food, medicine”

Medical schools could drop grades for poorer students

Medical schools could drop their grades for students from poorer backgrounds, meaning those with better results miss out, under a project which has sparked concern from academics.

Doctor at work - Asclepius

The project hasbeen launched by the Medical Schools Council Photo: Getty

 

Laura Donnelly

By , Health Correspondent

10:00PM BST 02 Jul 2013

A national scheme promising “rapid progress” to help aspiring doctors from under-represented social and economic backgrounds will recommend changes to selection methods employed by medical schools to recruit more students from deprived groups.

The project, which has just been launched by the Medical Schools Council, will examine whether more use should be made of “contextual data” – information on candidates’ school, ethnicity, postcode, family income and level of parental education – to give students with lower grades a place.

Professor Tony Weetman, the council’s chairman said the initiative was “a commitment from the UK’s medical schools and indeed the whole of the medical profession to ensure we are selecting the right people for a career as a doctor”.

He said that while medical schools would retain autonomy in choosing their candidates, they needed to do more to recruit candidates from deprived backgrounds, just as action had been taken to recruit more female doctors and black and ethnic minority groups.

Prof Weetman said: “A medical team which can fully recognise the diversity of the population it serves will be better placed to meet the UK’s increasingly complex health needs.”

But last night Prof Alan Smithers, director of the Centre for Education and Employment Research at University of Buckingham, said he was concerned that good sense had been lost in a rush to promote equality.

He said: “I’m very concerned about this. Equality and opportunity is very important but in medicine we do need to have candidates of the highest ability; background shouldn’t be a barrier but candidates for medical school shouldn’t have an advantage over others because of where they were brought up.”

He said he was concerned that candidates with a strong academic record would lose places, which would not only be unfair for them, but could also damage the future health of the nation.

“The most important thing is that succesful candidates have the skills to diagnose accurately and treat their patients,” he said. “We are letting the climate of equality run away with us.”

The project, which has been endorsed by ministers, follow recommendations last month from Alan Milburn, the Government’s social mobility tsar, that universities should recruit 3,700 more state school students, and allow lower grades for those from poorly performing schools.

Last night Dr Dan Poulter, Health Minister, said “In recent years we have made significant progress towards a more meritocratically selected medical workforce. But there is still more to do. I want to encourage students from every background to think about being a doctor – that’s why I’m pleased that the Medical Schools Council is getting more pupils from deprived backgrounds involved.”

The initiative will also look at the use of “outreach” programmes to encourage children from poor backgrounds to consider a career as a doctor, and schemes to give them work experience in the NHS.

Members of the project include Professor Les Ebdon, Director of Fair Access to Higher Education, who said the initiative aimed to ensure that no-one is put off from entering the profession because of family background or income.

Physicians’ brain scans indicate doctors can feel their patients’ pain — and their relief

Contact: Bonnie Prescott bprescot@bidmc.harvard.edu 617-667-7306 Beth Israel Deaconess Medical Center

Novel experiment illuminates the importance of the doctor-patient relationship

BOSTON – A patient’s relationship with his or her doctor has long been considered an important component of healing. Now, in a novel investigation in which physicians underwent brain scans while they believed they were actually treating patients, researchers have provided the first scientific evidence indicating that doctors truly can feel their patients’ pain – and can also experience their relief following treatment.

Led by researchers at Massachusetts General Hospital (MGH) and the Program in Placebo Studies and Therapeutic Encounter (PiPS) at Beth Israel Deaconess Medical Center/Harvard Medical School, the new findings, which appear on-line today in Molecular Psychiatry, help to illuminate one of the more intangible aspects of health care – the doctor/patient relationship.

“Our findings showed that the same brain regions that have previously been shown to be activated when patients receive placebo therapies are similarly activated in the brains of doctors when they administer what they think are effective treatments,” explains first author Karin Jensen, PhD, an investigator in the Department of Psychiatry and Martinos Center for Biomedical Imaging at MGH and member of the PiPS. Notably, she adds, the findings also showed that the physicians who reported greater ability to take things from the patients’ perspective, that is, to empathize with patients’ feelings, experienced higher satisfaction during  patients’ treatments, as reflected in the brain scans.

“By demonstrating that caring for patients involves a complex set of brain events, including deep understanding of the patient’s facial and body expressions, possibly in combination with the physician’s own expectations of relief and feelings of reward, we have been able to elucidate the neurobiology underlying caregiving,” adds senior author Ted Kaptchuk, director of the PiPS and Associate Professor of Medicine at Harvard Medical School. “Our findings provide early evidence of the importance of interacting brain networks between patients and caregivers and acknowledge the doctor/patient relationship as a valued component of health care, alongside medications and procedures.”

Previous investigations have demonstrated that a brain region associated with pain relief (right ventrolateral prefrontal cortex, VLPFC) and a region associated with reward (rostral anterior cingulate cortex, rACC) are activated when patients experience the placebo effect, which occurs when patients show improvement from treatments that contain no active ingredients. The placebo effect accounts for significant portions of clinical outcomes in many illnesses — including pain, depression and anxiety.

Although behavioral research has suggested that physicians’ expectations influence patients’ clinical outcomes and help determine patients’ placebo responses, until now little effort has been directed to understanding the biology underlying the physician component of the clinical relationship. Jensen and her colleagues hypothesized that the same brain regions that are activated during patients’ placebo responses – the VLPFC and rACC — would similarly be activated in the brains of physicians as they treated patients. They also hypothesized that a physician’s perspective-taking skills would influence the outcomes.

To test these hypotheses, the scientists developed a unique equipment arrangement that would enable them to conduct functional magnetic resonance imaging (fMRI) of the physicians’ brains while the doctors had face-to-face  interactions with patients, including observing patients as they underwent pain treatments.

The experiment included 18 physicians (all of whom had received their medical degree within the last 10 years and represented nine separate medical specialties). Two 25-year-old females played the role of “patients” and followed a rehearsed script. The experiment called for the participating physicians to  administer pain relief with what they thought was a pain-relieving electronic device, but which was actually a non-active “sham” device.

To ensure that the physicians believed that the sham device really worked, the investigators first administered a dose of “heat pain” to the physicians’ forearms to gauge pain threshold and then “treated” them with the fake machine. During the treatments, the investigators reduced the heat stimulation, to demonstrate to the participants that the therapy worked. The physicians underwent fMRI scans while they experienced the painful heat stimulation so that investigators could see exactly which brain regions were activated during first-person perception of pain.

In the second portion of the experiment,each physician was introduced to a patient and asked to perform a standardized clinical examination, which was conducted in a typical exam room for approximately 20 minutes. (The clinical exam was performed in order to establish a realistic rapport between the physician and patient before fMRI scanning took place, and was comparable to a standard U.S. doctor’s appointment.) At this point the physician also answered a questionnaire, the Interpersonal Reactivity Index, used to measure the participant’s self-reported perspective-taking skills.

During the third step, says Jensen, the physician and patient were led into the scanner room. “The physician went inside the scanner and was equipped with a remote control that could activate the ‘analgesic device’ when prompted,” she explains. Mirrors inside the scanner enabled physicians to maintain eye contact with the patient, who was seated on a chair next to the scanner’s bed and hooked up to both the thermal pain stimulator and the pain-relieving device.

Then, in a randomized order, physicians were instructed to either treat a patient’s pain or to press a control button that provided no relief. When physicians were told not to activate pain relief, the “patient” exhibited a painful facial expression while the physicians watched. When the physicians were instructed to treat the patients’ pain, they could see that the subjects’ faces were neutral and relaxed, the result of pain relief. During these doctor-patient interactions, fMRI scans measured the doctors’ brain activations.

Following the scanning session, the physicians were removed from the scanner and told exactly how the experiment had been performed, says Jensen. “If the physician did not agree with the deceptive component of the study, they were given the opportunity to withdraw their data. No one did this.”

As predicted, the authors found that while treating patients, the physicians activated the right VLPFC region of the brain, a region previously implicated in the placebo response. Furthermore, Jensen adds, the physicians’ ability to take the patients’ viewpoints correlated to brain activations and subjective ratings; physicians who reported high perspective-taking skills were more likely to show activation in the rACC brain region, which is associated with reward.

“We already know that the physician-patient relationship provides solace and can even relieve many symptoms,” adds Kaptchuk. “Now, for the first time, we’ve shown that caring for patients encompasses a unique neurobiology in physicians. Our ultimate goal is to transform the ‘art of medicine’ into the ‘science of care,’ and this research is an important first step in this process as we continue investigations to find out how patient-clinician interactions can lead to measurable clinical outcomes in patients.”

###

In addition to Jensen and Kaptchuk, study coauthors include MGH and PiPS investigators Jacqueline Raicek, Alexandra Cheetham, Rosa Spaeth, Amanda Cook, Randy L. Gollub, and Jian Kong; Predrag Petrovic of the Karolinska Institute, Stockholm, Sweden;  and Irving Kirsch of the PiPS.

This study was funded, in part, by the Swedish Society for Medical Research and the Swedish Council for Working Life and Social Research, Osher Center for Integrative Medicine (Karolinska Institute) and by NIH grants from the National Center on Complementary and Alternative Medicine (K24AT004095; P01 AT003883; R21AT004497; R01AT006364; R01AT005280), the National Institute on Drug Abuse (R03AT218317); and the National Center for Research Resources (M01-RR-01066 and UL1 RR025758-01; and P41RR14075).

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and currently ranks third in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of the Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit www.bidmc.org.

Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $750 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, transplantation biology and photomedicine. In July 2012, MGH moved into the number one spot on the 2012-13 U.S. News & World Report list of “America’s Best Hospitals.”

No standard for the placebo? ” placebo ingredients for pills were disclosed in fewer than 10 percent of cases “

2010 study posted for filing

Contact: Debra Kain ddkain@ucsd.edu 619-543-6163 University of California – San Diego

Much of medicine is based on what is considered the strongest possible evidence: The placebo-controlled trial. A paper published in the October 19 issue of  Annals of Internal Medicine – entitled “What’s In Placebos: Who Knows?” calls into question this foundation upon which much of medicine rests, by showing that there is no standard behind the standard – no standard for the placebo.

The thinking behind relying on placebo-controlled trials is this: to be sure a treatment itself is effective, one needs to compare people whose only difference is whether or not they are taking the drug. Both groups should equally think they are on the drug – to protect against effects of factors like expectation. So study participants are allocated “randomly” to the drug or a “placebo” – a pill that might be mistaken for the active drug but is inert.

But, according to the paper’s author, Beatrice Golomb, MD, PhD, associate professor of medicine at the University of California, San Diego School of Medicine, this standard has a fundamental problem, “there isn’t anything actually known to be physiologically inert. On top of that, there are no regulations about what goes into placebos, and what is in them is often determined by the makers of the drug being studied, who have a vested interest in the outcome. And there has been no expectation that placebos’ composition be disclosed. At least then readers of the study might make up their own mind about whether the ingredients in the placebo might affect the interpretation of the study.”

Golomb pointed out these limitations to the placebo in a pair of letters to the journal Nature 15 years ago.

“A positive or negative effect of the placebo can lead to the misleading appearance of a negative or positive effect of the drug,” she said. “And an effect in the same direction as the drug can lead a true effect of the drug to be lost. These concerns aren’t just theoretical. Where the composition has been disclosed, the ingredients of the placebo have in some instances had a likely impact on the result of the study – in either direction (obscuring a real effect, or creating a spurious one). In the cases we know about, this is not because of any willful manipulation, but because it can in fact be difficult to come up with a placebo that does not have some kind of problem.”

Since 15 years have elapsed, the situation might have improved. Therefore, Golomb and her colleagues analyzed just how often randomized trials published in the past two years in each of the top four general medical journals actually disclosed the makeup of placebos.

The answer is not reassuring, according to the researchers, who found that the placebo ingredients for pills were disclosed in fewer than 10 percent of cases. (The nature of the “control” was significantly more likely to be stated for other types of treatments – like injections, acupuncture, or surgery – where people are more likely to question what “placebo” actually means.)

“How often study results are affected by what’s in the placebo is hard to say – because, as this study showed, most of the time we have no idea what the placebo is,” Golomb concluded.

###

Additional contributors to the study included Laura C. Erickson, BS, Sabrina Koperski, BS, Deanna Sack, BS, and UCSD Department of Medicine; Murray Enkin, MD, Departments of Obstetrics and Gynaecology, McMaster University, Ontario, Canada; and Jeremy Howick, PhD, Centre for Evidence-Based Medicine, University of Oxford, England.

Personhood: Causality of Modern Medicine

Professor Emeritus of Family Medicine at the University of Washington School of Medicine

Posted: 12/06/2012  1:38 pm

Even as we marvel at the latest advances in medical technology in this country, a dire and unacceptable consequence of these changes is already in plain sight — the loss of the patient as person in the process of our fragmented and dysfunctional health care “system.”

There are so many ways in which patients as persons get lost in the increasingly-chaotic landscape of today’s health care environment. These are some of the trends that perpetuate and escalate this problem:

    • A multi-payer financing system with some 1,300 private insurance companies  that creates perverse incentives for physicians and other providers to deliver increased volume of inappropriate and unnecessary services to grow their revenues.
  • Lack of price controls throughout the system.

 

  • A largely for-profit private health insurance industry that profits by covering less care.

 

  • A system driven by a business ethic more than a service ethic, with health care just another commodity for sale on an open market.

 

  • A medical-industrial complex that has become solidly entrenched over the last 40 years with tremendous economic and political power.

 

  • Reimbursement policies that favor procedures and specialized services over more time-intensive services typical of primary care, geriatrics and psychiatry.

 

  • A physician workforce that has become dominated by non-primary care specialists with little knowledge of the patients as persons, as members of families and communities.

 

  • A disconnect between ambulatory care and hospital care, with primary care physicians following their patients into the hospital now a rarity.

 

  • Hospitalists trying to coordinate hospital care of patients with little knowledge of their prior care and often insufficient communication among multiple specialists.

 

  • A growing use of electronic medical records, a necessary and welcome change but marred by competing systems that don’t speak to each other and largely omit any information of patients as persons.

 

As a result of these changes, the present state of health care in this country to an increasing extent  involves strangers caring for strangers, with patients’ narratives and life stories no longer a key element guiding decisions about their own health care. This is a serious problem, not yet part of our national conversation, that has led to a growing gap between the care that patients need and deserve and what they receive.

Can the person be restored as the central object of health care in today’s profit-driven system? The challenges are daunting and will require a long-term social, economic, political and cultural shift. In a broad view, we need a paradigm shift similar to that of the Copernican revolution, when the Renaissance astronomer conceived a heliocentric cosmology that displaced the Earth from the center of the universe. Such a shift in U.S. health care, that puts patients and families at the center of health care, is illustrated here.

As has already occurred in most advanced countries around the world, we need to turn around how we think about health care in this country in these kinds of ways:

    • Shifting from a system based on ability to pay to one based on medical need.
  • Moving from health care as a commodity to a basic human right and need.

 

  • Moving from a dysfunctional, fragmented and exploitative private health insurance industry to a single-payer improved Medicare for All coupled with a private delivery system.

 

  • Moving from political- and lobbyist-driven coverage policies toward those based on scientific evidence of efficacy and cost-effectiveness.

 

  • Replacing today’s unaccountable system with one that stewards limited health care resources for the benefit of all Americans in a single risk pool (“Everybody in, nobody out”).

 

Many lines of reform would help to move present dynamics in health care toward a more patient-centered process. Financing and payment reforms would go a long way in that direction. Improved Medicare for All (H.R. 676) would establish universal access to health care for all Americans. It would also facilitate other enabling steps, such as achieving price controls on the supply side and encouraging growth of new approaches to primary care that are more person-centered.

The missing element in today’s depersonalized health care is time — listening and talking time between patients, their physicians and other health care professionals — during which patients can relate their narratives that can then be integrated into plans for their care. We already know that trust between physicians and patients built over years improves medical outcomes and enhances healing.

As system problems of U.S. health care impact more ordinary Americans with diminished access to affordable care, and as growing millions forego essential care, we are now seeing a renewal of literature in the medical humanities as a counter trend  to depersonalized care that too often does not meet patients’ needs. Health Affairs, as the premier health policy journal, has had a regular feature for years dealing with patient narratives. The American Medical Student Association (AMSA) has established its Humanities Institute, now offering workshops exploring the art of medicine, including sessions on narrative medicine and writing for social justice. A number of books are charting new territory in this direction, including Norman Cousins’ Anatomy of an Illness, Arthur Kleinman’s The Illness Narratives, Howard Brody’s Stories of Sickness, and Rita Charon’s Narrative Medicine: Honoring the Stories of Illness. Copernicus Healthcare is adding to this promising trend with its forthcoming release of The Art of Medicine in Metaphors: A Collection of Poems and Narratives, edited by James Borton. This kind of writing builds on a rich earlier tradition of medical writing in this genre, including the poetry of Dr. William Carlos Williams in the last century.

As Dr. Charon notes in her 2006 book:

I hope that the frame of narrative medicine can gather new combinations of us — from the humanities, from all the health professions, from the lay world, the business world, the political world — and make new relations among us, so as to look with refreshed eyes at what is means to be sick and to help others get well. (1)

This hope gives us a vision toward better, more humane health care. Admittedly, it is a Herculean task to reverse well-entrenched trends in our dysfunctional market-based health care system, and paradigm shifts take a long time.  But our present system is not sustainable, reforms are not impossible, and in order to progress, we first need this kind of vision.

(1) Charon, R. Narrative Medicine: Honoring the Stories of Illness, New York. Oxford University Press, 2006, p. xiii.

http://www.huffingtonpost.com/john-geyman/health-care-reform_b_2245540.html

 

Compound found in rosemary protects against macular degeneration in laboratory model

Contact: Heather Buschman, Ph.D. hbuschman@sanfordburnham.org 858-795-5343 Sanford-Burnham Medical Research Institute

Sanford-Burnham researchers discover that carnosic acid, a component of the herb rosemary, promotes eye health in rodents—providing a possible new approach for treating conditions such as age-related macular degeneration

      IMAGE:   Left: This shows control cells exposed to hydrogen peroxide. Right: This shows cells treated with carnosic acid are protected from hydrogen peroxide. Live cells are stained green, dead cells are…Click here for more information.

 

LA JOLLA, Calif., November 27, 2012 – Herbs widely used throughout history in Asian and early European cultures have received renewed attention by Western medicine in recent years. Scientists are now isolating the active compounds in many medicinal herbs and documenting their antioxidant and anti-inflammatory activities. In a study published in the journal Investigative Ophthalmology & Visual Science, Stuart A. Lipton, M.D., Ph.D. and colleagues at Sanford-Burnham Medical Research Institute (Sanford-Burnham) report that carnosic acid, a component of the herb rosemary, promotes eye health.

Lipton’s team found that carnosic acid protects retinas from degeneration and toxicity in cell culture and in rodent models of light-induced retinal damage. Their findings suggest that carnosic acid may have clinical applications for diseases affecting the outer retina, including age-related macular degeneration, the most common eye disease in the U.S.

Age-related macular degeneration

Age-related macular degeneration likely has many underlying causes. Yet previous studies suggest that the disease might be slowed or improved by chemicals that fight free radicals—reactive compounds related to oxygen and nitrogen that damage membranes and other cell processes.

Lipton’s team first discovered a few years ago that carnosic acid fights off free radical damage in the brain. In their latest study, Lipton and colleagues, including Tayebeh Rezaie, Ph.D. and Takumi Satoh, Ph.D., initially investigated carnosic acid’s protective mechanism in laboratory cultures of retinal cells.

The researchers exposed the cells growing in the dish to hydrogen peroxide in order to induce oxidative stress, a factor thought to contribute to disease progression in eye conditions such as macular degeneration and retinitis pigmentosa. They found that cells treated with carnosic acid triggered antioxidant enzyme production in the cells, which in turn lowered levels of reactive oxygen and nitrogen species (cell-damaging free radicals and peroxides).

Rosemary’s therapeutic potential

Lipton, Rezaie, Satoh and colleagues next tested carnosic acid in an animal model of light-induced damage to photoreceptors—the part of the eye that converts light to electrical signals, enabling visual perception. As compared to the untreated group, rodents pre-treated with carnosic acid retained a thicker outer nuclear layer in the eye, indicating that their photoreceptors were protected. The carnosic acid-treated rodents also exhibited better electroretinogram activity, a measure of healthy photoreceptor function.

What’s next for carnosic acid? “We’re now developing improved derivatives of carnosic acid and related compounds to protect the retina and other brain areas from a number of degenerative conditions, including age-related macular degeneration and various forms of dementia,” said Lipton, director of Sanford-Burnham’s Del E. Webb Neuroscience, Aging, and Stem Cell Research Center and an active clinical neurologist.

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Note to members of the media: Please contact Heather Buschman at hbuschman@sanfordburnham.org to schedule on-site, phone, or Skype interviews with Stuart A. Lipton, M.D., Ph.D. Images are also available upon request.

This research was funded by the U.S. National Institutes of Health: Eunice Kennedy Shriver National Institute of Child Health & Human Development grant P01 HD29587; National Institute of Environmental Health Sciences grant P01 ES016738; National Institute of Neurological Disorders and Stroke grant P30 NS076411; National Eye Institute grant R01 EY05477

The study was co-authored by Tayebeh Rezaie, Sanford-Burnham; Scott R. McKercher, Sanford-Burnham; Kunio Kosaka, Nagase & Co., Ltd.; Masaaki Seki, Sanford-Burnham; Larry Wheeler, Allergan, Inc.; Veena Viswanath, Allergan, Inc.; Teresa Chun, Allergan, Inc.; Rabina Joshi, Sanford-Burnham; Marcos Valencia, Sanford-Burnham; Shunsuke Sasaki, Iwate University; Terumasa Tozawa, Iwate University; Takumi Satoh, Sanford-Burnham and Iwate University; and Stuart A. Lipton, Sanford-Burnham.

About Sanford-Burnham Medical Research Institute

Sanford-Burnham Medical Research Institute is dedicated to discovering the fundamental molecular causes of disease and devising the innovative therapies of tomorrow. The Institute consistently ranks among the top five organizations worldwide for its scientific impact in the fields of biology and biochemistry (defined by citations per publication) and currently ranks third in the nation in NIH funding among all laboratory-based research institutes. Sanford-Burnham utilizes a unique, collaborative approach to medical research and has established major research programs in cancer, neurodegeneration, diabetes, and infectious, inflammatory, and childhood diseases. The Institute is especially known for its world-class capabilities in stem cell research and drug discovery technologies. Sanford-Burnham is a U.S.-based, non-profit public benefit corporation, with operations in San Diego (La Jolla), California and Orlando (Lake Nona), Florida. For more information, news, and events, please visit us at sanfordburnham.org.

The brain may feel other people’s pain

2009 study posted for filing

 

By Amy Norton Amy Norton

 

NEW YORK (Reuters Health) – If you’ve ever thought that you literally feel other people’s pain, you may be right. A brain-imaging study suggests that some people have true physical reactions to others’ injuries.

 

Using an imaging technique called functional MRI, UK researchers found evidence that people who say they feel vicarious pain do, in fact, have heightened activity in pain-sensing brain regions upon witnessing another person being hurt.

 

The findings, published in the journal Pain, could have implications for understanding, and possibly treating, cases of unexplained “functional” pain.

 

“Patients with functional pain experience pain in the absence of an obvious disease or injury to explain their pain,” explained Dr. Stuart W. G. Derbyshire of the University of Birmingham, one of the researchers on the new study.

 

“Consequently,” he told Reuters Health in an email, “there is considerable effort to uncover other ways in which the pain might be generated.”

 

Derbyshire said he now wants to study whether the brains of patients with functional pain respond to images of injury in the same way that the current study participants’ did.

 

For the study, Derbyshire and colleague Jody Osborn first had 108 college students view several images of painful situations — including athletes suffering sports injuries and patients receiving an injection. Close to one-third of the students said that, for at least one image, they not only had an emotional reaction, but also fleetingly felt pain in the same site as the injury in the image.

 

Derbyshire and Osborn then took functional MRI scans of 10 of these “responders,” along with 10 “non-responders” who reported no pain while viewing the images.

 

Functional MRI charts changes in brain blood flow, allowing researchers to see which brain areas become more active in response to a particular stimulus. Here, the researchers scanned participants’ brains as they viewed either images of people in pain, images that were emotional but not painful, or neutral images.

 

The investigators found that while viewing the painful images, both responders and non-responders showed activity in the emotional centers of the brain. But responders showed greater activity in pain-related brain regions compared with non-responders, and as compared with their own brain responses to the emotional images.

 

“We think this confirms that at least some people have an actual physical reaction when observing others being injured or expressing pain,” Derbyshire said.

 

He noted that the responders also tended to say that they avoided horror movies and disturbing images on the news “so as to avoid being in pain” — which, the researcher said, is more than just an empathetic response.

 

As far as the potential practical implications of the findings, Derbyshire said it would be a “reach” to think that such brain mechanisms might be behind all functional pain. But, he added, “they might explain some of it.”

Common herbal medicine may prevent acetaminophen-related liver damage, says Stanford researcher : S-methylmethionine

2009 study posted for filing

Contact: Krista Conger kristac@stanford.edu 650-725-5371 Stanford University Medical Center

STANFORD, Calif. — A well-known Eastern medicine supplement may help avoid the most common cause of liver transplantation, according to a study by researchers at the Stanford University School of Medicine. The finding came as a surprise to the scientists, who used a number of advanced genetic and genomic techniques in mice to identify a molecular pathway that counters acetaminophen toxicity, which leads to liver failure.

“I didn’t know anything about the substance that was necessary for the pathway’s function, so I had to look it up,” said Gary Peltz, MD, PhD, professor of anesthesiology. “My postdoctoral fellow, whose parents and other family members in Asia were taking this compound in their supplements, started laughing. He recognized it immediately.”

The molecule was S-methylmethionine, which had been marketed as an herbal medicine known as Vitamin U for treatment of the digestive system. It is highly abundant in many plants, including cabbage and wheat, and is routinely ingested by people. Coincidentally, Garnett Cheney, MD, at Stanford University performed a series of studies in the 1950s in which he used the compound to treat peptic ulcers.

Peltz is the senior author of the research, which will be published online Nov. 18 in Genome Research. The experiments were conducted in Peltz’s laboratory at Roche Palo Alto in Palo Alto, Calif., where Peltz worked before coming to Stanford in July 2008. He is continuing the research at Stanford. The first author of the paper, Hong-Hsing Liu, MD, PhD, is now a postdoctoral scholar in Peltz’s Stanford lab.

Acetaminophen is a pain reliever present in many over-the-counter cold and flu medicines. It is broken down, or metabolized, in the body into byproducts — one of which can be very toxic to the liver. At normal, therapeutic levels, this byproduct is easily deactivated when it binds to a naturally occurring, protective molecule called glutathione. But the body’s glutathione stores are finite, and are quickly depleted when the recommended doses of acetaminophen are exceeded.

Unfortunately, the prevalence of acetaminophen makes it easy to accidentally exceed the recommended levels, which can occur by dosing more frequently than indicated or by combining two or more acetaminophen-containing products. However, severe liver damage can occur at even two to three times the recommended dose (the maximum adult dose is 4 grams per day; toxic daily levels range from 7 to 10 grams).

“It’s a huge public health problem,” said Peltz. “It’s particularly difficult for parents, who may not realize that acetaminophen is in so many pediatric medicines.” Acetaminophen overdose is the most common cause of liver transplantation in this country. The only effective antidote is an unpalatable compound called NAC that can induce nausea and vomiting, and must be administered as soon as possible after the overdose.

Peltz and his colleagues used 16 inbred strains of laboratory mice for their investigations. Most strains are susceptible to acetaminophen toxicity, but one is resistant. They compared how the drug is metabolized by the different strains and looked for variations in gene expression and changes in endogenous metabolites in response to acetaminophen administration. They identified 224 candidate genes that might explain the resistant strain’s ability to ward off liver damage, and then plumbed computer databases to identify those involved in metabolizing acetaminophen’s dangerous byproducts.

One, an enzyme called Bhmt2, fit the bill: It helped generate more glutathione, and its sequence varied between the resistant and non-resistant strains of mice. Bhmt2 works by converting the diet-derived molecule S-methylmethionine, or SMM, into methionine, which is subsequently converted in a series of steps into glutathione. The researchers confirmed the importance of the pathway by showing that SMM conferred protection against acetaminophen-induced liver toxicity only in strains of mice in which the Bhmt2 pathway was functional.

“By administering SMM, which is found in every flowering plant and vegetable, we were able to prevent a lot of the drug’s toxic effect,” said Peltz. He and his colleagues are now working to set up clinical trials at Stanford to see whether it will have a similar effect in humans. In the meantime, though, he cautions against assuming that dosing oneself with SMM will protect against acetaminophen overdose.

“There are many pathways involved in the metabolism of this drug, and individuals’ genetic backgrounds are tremendously variable. This is just one piece of the puzzle; we don’t have the full answer,” he said. However, if subsequent studies are promising, Peltz envisions possibly a co-formulated drug containing both acetaminophen and SMM or using SMM as a routine dietary supplement.

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The research was partially funded by the Institute of General Medical Sciences and the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health and by Roche. Peltz and Liu are the co-inventors on a patent filed on the use of SMM to prevent acetaminophen toxicity in humans. SandHill Bio, a drug discovery startup co-founded by Peltz, is further investigating the potential therapeutic applications of the finding.

The Stanford University School of Medicine consistently ranks among the nation’s top 10 medical schools, integrating research, medical education, patient care and community service. For more news about the school, please visit http://mednews.stanford.edu. The medical school is part of Stanford Medicine, which includes Stanford Hospital & Clinics and Lucile Packard Children’s Hospital. For information about all three, please visit http://stanfordmedicine.org/about/news.html.

BROADCAST MEDIA CONTACT: M.A. Malone at (650) 723-6912 (mamalone@stanford.edu)

Radioprotection and extracts of Ginko biloba

Contact: Chang-Mo Kang
kangcm@kcch.re.kr
Inderscience Publishers

Herbal tonic for radiotherapy

Antioxidant extracts of the leaves of the Gingko biloba tree may protect cells from radiation damage, according to a study published in the International Journal of Low Radiation. The discovery may one day be used to help reduce side effects in cancer patients undergoing radiotherapy.

Chang-Mo Kang of the Korea Institute of Radiological and Medical Sciences in Taegu and colleagues are interested in the protective effects of well-known herbal remedies of which Gingko biloba is one. G. biloba is a unique tree species with no close living relatives and extracts of its leaves contain antioxidant compounds including glycosides and terpenoids known as ginkgolides and bilobalides.

These compounds are thought to protect cells from damage by free radicals and other reactive oxidizing species found in the body. These are generated continuously by the body’s normal metabolism, and in excess in some diseases or after exposure to pollution or radiation. They damage proteins, DNA and other biomolecules and left unchecked can kill cells.

As such, extracts of certain plants that contain antioxidants, including G. biloba, have attracted interest for their pharmacological activity. G. biloba is currently sold as a herbal supplement and there are numerous claims for health benefits, including the possibility of preventing the onset of dementia or Alzheimer’s disease.

Kang and colleagues have now collected human white blood cells, lymphocytes, from healthy donors aged 18 to 50 years. They treated half of these cells with commercially available G. biloba extract in the laboratory and doused the other half with salt solution as an experimental control. They then compared the effects of gamma radiation from radioactive cesium on the white blood cells compared to the untreated control samples.

The team uses a light microscope to look for lymphocytes undergoing programmed cell death, or apoptosis, as a result of radiation exposure. They found that there was a significant increase in apoptosis in the untreated cells compared with those treated with G. biloba extract. Almost a third of the untreated cells underwent apoptosis compared with approximately one in twenty of the treated cells. Parallel studies with laboratory mice also demonstrated a similar protective effect against radiation poisoning.

The results suggest that the extracts can neutralize the free-radicals and oxidizing agents produced in the cells by the radiation and so prevent them from undergoing apoptosis.

 

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“Protective effect of Gingko biloba against radiation-induced cellular damage in human peripheral lymphocytes and murine spleen cells” in Int. J. Low Radiation, 2009, 6, 209-218

Rich people don’t need friends

2009 study posted for filing
Contact: Steve Pogonowski
steve.pogonowski@f1000.com
Faculty of 1000: Biology and Medicine

In a paper evaluated by f1000 Medicine, six studies tested relationships between reminders of money, social exclusion and physical pain.

In The symbolic power of money: reminders of money alter social distress and physical pain published in the journal Psychological Science, Xinyue Zhou, Kathleen Vohs and Roy Baumeister explored how money could reduce a person’s feeling of pain and also negate their need for social popularity.

Harriet de Wit, Faculty Member for f1000 Medicine, said: “This research extends our understanding of relationships between social pain and physical pain, and remarkably, shows how acquired symbolic value of money, perhaps because of associations with power or control, can influence responses to both emotional and physical pain.”

She also noted: “These findings have great importance for a social system such as ours that is characterized by wide disparities in financial wellbeing.”

Zhou, Vohs and Baumeister determined that interpersonal rejection and physical pain caused desire for money to increase. They said: “Money can possibly substitute for social acceptance in conferring the ability to obtain benefits from the social system. Moreover, past work has suggested that responses to physical pain and social distress share common underlying mechanisms.”

“Handling money (compared with handling paper) reduced distress over social exclusion and diminished the physical pain of immersion in hot water. Being reminded of having spent money, however, intensified both social distress and physical pain,” the authors said.

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Media Contact
Steve Pogonowski
PR Manager
Faculty of 1000
+44 (0) 20 7631 9134
steve.pogonowski@f1000.com

Notes to Editors

1 Professor de Wit is Director of the Human Behavioral Pharmacology Laboratory at the University of Chicago. Her profile can be viewed at http://f1000medicine.com/member/8764194356909390

2 The full text of the evaluation of “The Symbolic Power of Money: Reminders of Money Alter Social Distress and Physical Pain” is available free for 90 days at http://www.f1000medicine.com/article/r2111rwty080l4q/id/1163818DOI: 10.1111/j.1467-9280.2009.02353.x

3 Please name Faculty of 1000 Medicine in any story you write. If you are writing for the web, please link to the website.

4 Faculty of 1000 Medicine, http://f1000medicine.com, is a unique online service that helps you stay informed of high impact articles and access the opinions of global leaders in medicine. Our distinguished international faculty select and evaluate key articles across medicine, providing a rapidly updated, authoritative guide to the medical literature that matters.

5 Please contact Steve Pogonowski, PR Manager, for a complimentary journalist subscription to Faculty of 1000 http://f1000.com.

Study Shows Common Pain Cream Could Protect Heart During Attack: 85 percent reduction in cardiac cell death

2009 study posted for filing

Study Shows Common Pain Cream Could Protect Heart During Attack

 

 

CINCINNATI—New research from the University of Cincinnati shows that a common, over-the-counter pain salve rubbed on the skin during a heart attack could serve as a cardiac-protectant, preventing or reducing damage to the heart while interventions are administered.

 

These findings are published in the Sept. 14 edition of the journal Circulation.

 

Keith Jones, PhD, a researcher in the department of pharmacology and cell biophysics, and scientists in his lab have found that applying capsaicin to specific skin locations in mice caused sensory nerves in the skin to trigger signals in the nervous system. These signals activate cellular “pro-survival” pathways in the heart which protect the muscle.

 

Capsaicin is the main component of chili peppers and produces a hot sensation. It is also the active ingredient in several topical medications used for temporary pain relief.

 

Capsaicin is approved for use by the U.S. Food and Drug Administration.

 

Jones is working with Neal Weintraub, MD, a UC Health cardiologist and director of UC’s cardiovascular diseases division, and other clinicians to construct a translational plan to test capsaicin in a human population.

 

“Topical capsaicin has no known serious adverse effects and could be easily applied in an ambulance or emergency room setting well in advance of coronary tissue death,” Jones says. “If proven effective in humans, this therapy has the potential to reduce injury and/or death in the event of a coronary blockage, thereby reducing the extent and consequences of heart attack.”

 

Researchers observed an 85 percent reduction in cardiac cell death when capsaicin was used.

 

They also found that a small incision made on the abdomen triggered an 81 percent reduction.

 

“Both this and the capsaicin effect are shown to work through similar neurological mechanisms,” Jones says. “These are the most powerful cardioprotective effects recorded to date.

 

“This is a form of remote cardioprotection, using a skin stimulus that activates cardioprotection long before the blocked coronary artery is opened.”

 

 

Weintraub adds that this finding offers an important distinction between existing therapies.

 

“All of the current interventions require the vessel to be opened before doctors can act, and since it takes time to elicit protection, tissue dies,” he says. “This treatment will protect the heart before the vessel is opened while producing a strong protective effect that is already active when we open the vessel.”

 

Jones and Weintraub think that skin—the main sensor and largest human body organ—has evolved to protect animals, including humans, in a variety of ways.

 

“By activating these sensors in the nervous system, via skin, we think that a response to preserve and protect the heart is triggered,” Weintraub says.

 

“We think that this technique is fooling the body into sending out protective signals,” Jones adds. “This may be similar to the way certain acupuncture treatments work; there may be a neurological basis. In a broad sense, this work may provide a ‘Rosetta stone’ for translating alternative medicine techniques—like acupuncture—to Western medicine. Perhaps we can understand the biological mechanisms of how alternative treatments may be successful for patients.”

 

Now, researchers will further explore this concept by investigating which sensors are associated with certain aspects of organ protection—and how much of specific stimuli are needed to produce the desired responses.

 

“This could help create favorable outcomes for those who are experiencing stroke, shock or are in need of an organ transplant, and the best part is that it is done non-invasively and is relatively inexpensive,” Jones says.

 

But he warns against rubbing capsaicin on your belly if you feel like you are having a heart attack.

 

“We don’t know if it will work for all indications, for all patients, and we don’t know if it will work over an extended amount of time,” he says. “A major goal is testing this therapy in clinical trials, but we still need to study more about dosage and application—where we put it on the body for the best results. However, this has tremendous clinical potential and could eventually save lives.”

 

This study was funded by the National Institutes of Health and by the University of Cincinnati. Jones and Weintraub have filed a patent for this funding but have received no honoraria from the makers of capsaicin.

New evidence that popular dietary supplement may help prevent, treat cataracts: Carnosine

2009 study posted for filing

Contact: Michael Woods
m_woods@acs.org
202-872-6293
American Chemical Society

Biochemistry

Researchers are reporting evidence from tissue culture experiments that the popular dietary supplement carnosine may help to prevent and treat cataracts, a clouding of the lens of the eye that is a leading cause of vision loss worldwide. The study is scheduled for the July 28 edition of ACS’ Biochemistry, a weekly journal.

In the new study, Enrico Rizzarelli and colleagues note that the only effective treatment for cataracts is surgical replacement of the lens, the clear disc-like structure inside the eye that focuses light on the nerve tissue in the back of the eye. Cataracts develop when the main structural protein in the lens, alpha-crystallin, forms abnormal clumps. The clumps make the lens cloudy and impair vision. Previous studies hinted that carnosine may help block the formation of these clumps.

The scientists exposed tissue cultures of healthy rat lenses to either guanidine — a substance known to form cataracts — or a combination of guanidine and carnosine. The guanidine lenses became completely cloudy, while the guanidine/carnosine lenses developed 50 to 60 percent less cloudiness. Carnosine also restored most of the clarity to clouded lenses. The results demonstrate the potential of using carnosine for preventing and treating cataracts, the scientists say.

 

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ARTICLE #3 FOR IMMEDIATE RELEASE
“Protective Effects of L- and D-Carnosine on alpha-Crystallin Amyloid Fibril Formation: Implications for Cataract Disease”

DOWNLOAD FULL TEXT ARTICLE: http://pubs.acs.org/stoken/presspac/presspac/full/10.1021/bi900343n

CONTACT:
Enrico Rizzarelli, Ph.D.
Department of Chemical Sciences
University of Catania
Catania, Italy
Phone: 390957385070
Fax: 39095337678
Email: erizzarelli@unict.it

 

Probiotics help gastric-bypass patients lose weight more quickly, Stanford study shows

2009 study posted for filing

Contact: Diane Rogers
donut@stanford.edu
650-723-3900
Stanford University Medical Center

STANFORD, Calif. — New research from the Stanford University School of Medicine and Stanford Hospital & Clinics suggests that the use of a dietary supplement after Roux-en-Y gastric bypass surgery can help obese patients to more quickly lose weight and to avoid deficiency of a critical B vitamin.

In a study published in the July issue of the Journal of Gastrointestinal Surgery, John Morton, MD, associate professor of surgery at the medical school, showed that patients who take probiotics after the gastric-bypass procedure tend to shed more pounds than those who don’t take the supplements. Probiotics are the so-called “good” bacteria found in yogurt as well as in over-the-counter dietary supplements that help in the digestion of food.

“Surprisingly, the probiotic group attained a significantly greater percent of excess weight loss than that of control group,” said Morton, who wrote the paper with lead author Gavitt Woodard, a third-year medical student, and five other medical students at the Surgery Center for Outcomes Research and Evaluation in Stanford’s Department of Surgery. Morton has performed more than 1,000 of these bypasses at Stanford Hospital & Clinics.

The researchers followed 44 patients on whom Morton had performed the procedure from 2006 to 2007. Patients were randomized into either a probiotic or a control group. Both groups received the same bariatric medical care and nutritional counseling, as well as the support of weight-loss study groups. Both groups also were allowed to consume yogurt, a natural source of probiotics. In addition, the probiotic group consumed one pill per day of Puritan’s Pride, a probiotic supplement that is available online and in many stores. Morton has no financial ties to the company that makes the supplement.

The study showed that at three months, the probiotics group registered a 47.6 percent weight loss, compared with a 38.5 percent for the control group.

The study also found that levels of vitamin B-12 were higher in the patients taking probiotics — a significant finding because patients often are deficient in B-12 after gastric-bypass surgery. The probiotics group had B-12 levels of 1,214 picograms per milliliter at three months, compared with the control group’s levels of 811 pg/mL.

Morton said he now recommends probiotic supplements to his patients, and he plans to continue to look for ways to enhance the outcomes from the procedure.

Roughly 15 million Americans are morbidly obese, and bypass surgery is becoming an increasingly common treatment for the problem. Some 150,000 Americans who have a body mass index of more than 40 — who are typically at least 100 pounds overweight — have the procedure each year.

Morton said the study was prompted by the fact that some patients have problems eating after gastric-bypass surgery. “For some reason, the food doesn’t go down right,” he said. When no anatomical reasons could be found for blockages, he hypothesized that a build-up of bacteria in the intestine — bacterial overgrowth — might be the culprit.

“Bacterial overgrowth can be bad in that it changes your motility, how you empty,” Morton said. “A lot of people aren’t aware that we all carry about a lot of bacteria in our intestines and that they’re extremely helpful in aiding digestion. And I thought, ‘Well, if we give these patients probiotics, then maybe we can improve these symptoms.’

“Part of the obesity puzzle may be due to the kind of bacteria you have in your intestine,” he said.

 

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There was no outside funding for the study.

The Stanford University School of Medicine consistently ranks among the nation’s top 10 medical schools, integrating research, medical education, patient care and community service. For more news about the school, please visit http://mednews.stanford.edu. The medical school is part of Stanford Medicine, which includes Stanford Hospital & Clinics and Lucile Packard Children’s Hospital. For information about all three, please visit http://stanfordmedicine.org/about/news.html.

Stanford Hospital & Clinics is known worldwide for advanced treatment of complex disorders in areas such as cardiac care, cancer treatment, neurosciences, surgery, and organ transplants. Consistently ranked among the top institutions in the U.S. News and World Report annual list of “America’s Best Hospitals,” Stanford Hospital & Clinics is internationally recognized for translating medical breakthroughs into the care of patients. For more information, visit www.stanfordhospital.com.

PRINT MEDIA CONTACT: Diane Rogers at (650) 723-3900 (donut@stanford.edu)
BROADCAST MEDIA CONTACT: Liat Kobza at (650) 723-1462 (lkobza@stanfordmed.org)
(NOTE TO REPORTERS: A high-resolution image of John Morton is available for download at http://med.stanford.edu/news_releases/2009/download/morton.jpg)

Powerful nutrient cocktail can put kids with Crohn’s into remission

2009 study posted for filing

Contact: George Hunka
ghunka@aftau.org
212-742-9070
American Friends of Tel Aviv University

Tel Aviv University researcher promotes liquid nutrition to combat inflammatory bowel disease

Treating children with inflammatory bowel disease (IBD) usually involves the same steroids-based medication prescribed to adults. But such treatments can have negative side effects for kids and teens dealing with IBD.

Dr. Raanan Shamir of Tel Aviv University’s Sackler School of Medicine and Schneider Children’s Medical Centre shows that there is another path to treating IBD in children: a nutritional formula that was first developed for astronauts. This supplement puts 60-70% of children with Crohn’s disease, a common IBD disorder, into remission ― a success rate similar to that of traditional steroid-based drugs, but without side effects like malnutrition and growth retardation.

Dr. Shamir recently reported his research in the Journal of Pediatric Gastroenterology and Nutrition.

Eating Like an Astronaut

Dr. Shamir’s research was inspired by the problem of malnutrition and growth retardation in children battling IBD. Steroids and other biological agents, the most common treatment for IBD, were having an adverse affect on the children’s growth, despite their effectiveness in adult patients.

It was a problem first tackled by NASA: How could astronauts most efficiently get their daily nutrients? The answer was a specially-designed powder that contains all the daily nutrients a person needs. Aboard spacecrafts, astronauts dine on this nutritional powder mixed with water. Since then, these powders have become a common item on the pharmacy shelf.

A similar concept works wonders for children suffering from IBD. “Prepared powder, with liquids, gives you all the nutritional requirements you need for the day,” Dr. Shamir explains. “We don’t know why these formulas work, and nobody has shown that any one formula is preferable to another. People have to be committed and eat nothing else during the period of time they are on nutrition therapy, and it is difficult to do ― but if they do it, they go into remission.”

To induce remission, children need to be on nutrition therapy for 6-8 weeks. And in order to maintain remission, 25-50% of their caloric intake must be supplied by nutrition therapy, sometimes for years. This is why children experiencing the treatment need the support of physicians, dieticians, psychologists, and of course their families.

Dr. Shamir’s quest to educate the international medical community about the benefits of nutrition therapy has been an uphill battle. “The acceptance of this is difficult,” he says. “You have to persuade the family. Not all physicians know it works, and it’s much easier to give someone a prescription than try to work with the child.”

A Replacement for Steroids

“In adults, studies have shown that steroids are more effective in the battle against IBD than nutrition-based therapies. I think it is easier to get compliance from children, especially when it involves their growth. For adults, growth is not a concern ― they just want to feel better,” explains Dr. Shamir.

Dr. Shamir and his team of researchers have worked to show the international medical community that nutrition was equal to steroids in the treatment of children with IBD. “We published the most recent meta-analysis to show that nutrition is as good as steroids as a first-line therapy for Crohn’s disease,” he says.

The next step in his research, says Dr. Shamir, is to “define exactly the role of nutrition in inducing remission in these patients, and the role of nutrition in maintaining remission.”

 

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American Friends of Tel Aviv University (www.aftau.org) supports Israel’s leading and most comprehensive center of higher learning. In independent rankings, TAU’s innovations and discoveries are cited more often by the global scientific community than all but 20 other universities worldwide. Internationally recognized for the scope and groundbreaking nature of its research programs, Tel Aviv University consistently produces work with profound implications for the future.

Support for adjunctive vitamin C treatment in cancer

2009 study posted for filing

Contact: Amy Gleason Quarshie
agleason@liebertpub.com
914-740-2149
Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, March 5, 2009—Serious flaws in a recent study, which concluded that high doses of vitamin C reduce the effectiveness of chemotherapeutic drugs in the treatment of cancer, are revealed in the current issue of Alternative and Complementary Therapies, a journal published by Mary Ann Liebert, Inc. (www.liebertpub.com). This report is available free online at www.liebertpub.com/act

In the Medical Journal Watch column of the latest issue, Jack Challem, a personal nutrition coach and nutrition author from Tucson, Arizona, and a regular contributor to the Journal, challenges the findings of a study published in Cancer Research (2008;68:8031-8038), in which the authors conclude that vitamin C given to mice or cultured cells treated with common anti-cancer drugs reduces the antitumor effects of the chemotherapeutic agents.

Challem points out two main problems with the study: the oxidized form of vitamin C (dehydroascorbic acid) and not actual vitamin C (ascorbic acid) was used; and in the mouse experiments, the animals were given toxic doses of dehydroascorbic acid, a compound that is not used as a dietary supplement in humans.

“This study and the subsequent headlines [it generated] were a grievous disservice to physicians and patients with cancer,” says Challem. He adds that “considerable positive research…has shown striking benefits from high-dose vitamin C (ascorbic acid) in cancer cells and animals—and in actual human beings.”

High-dose intravenous vitamin C is a common form of alternative and complementary therapy for patients receiving chemotherapeutic drugs and is believed to help bring about tumor cell death. In addition, it may promote postsurgical healing by enhancing collagen formation, and increase tissue resistance to tumor spread.

Challem suggests that, “The ideal therapeutic approach would be to tailor individual treatment, including IV vitamin C, from a menu of options.”

 

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Alternative and Complementary Therapies is a bimonthly journal that publishes original research articles, reviews, and commentaries evaluating alternative therapies and how they can be integrated into clinical practice. Topics include botanical medicine, vitamins and supplements, nutrition and diet, mind-body medicine, acupuncture and Traditional Chinese Medicine, ayurveda, indigenous medicine systems, homeopathy, naturopathy, yoga and meditation, manual therapies, energy medicine, and spirituality and health. A complete table of contents and free sample issue may be viewed online at http://www.liebertpub.com/act

Mary Ann Liebert, Inc. (www.liebertpub.com), is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including The Journal of Alternative & Complementary Medicine, Medical Acupuncture, and Journal of Medicinal Food. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry’s most widely read publication worldwide. A complete list of the firm’s 60 journals, books, and newsmagazines is available at www.liebertpub.com

Mary Ann Liebert, Inc. 140 Huguenot St., New Rochelle, NY 10801-5215
Phone: (914) 740-2100 (800) M-LIEBERT Fax: (914) 740-2101
www.liebertpub.com

Garlic chemical tablet treats diabetes 1 and 2

2008 study posted for filing

Contact: Hiromu Sakurai
sakuraih@suzuka-u.ac.jp
Royal Society of Chemistry

Oral administration of vanadium-allixin compound lowers blood glucose levels in diabetic mice

A drug based on a chemical found in garlic can treat diabetes types I and II when taken as a tablet, a study in the new Royal Society of Chemistry journal Metallomics says.

When Hiromu Sakurai and colleagues from the Suzuka University of Medical Science, Japan, gave the drug orally to type I diabetic mice, they found it reduced blood glucose levels.

The drug is based on vanadium and allixin, a compound found in garlic, and its action described in an Advance Article from Metallomics available free online from today. The first issue of the new journal will be published in 2009.

In previous work they had discovered the vanadium-allixin compound treated both diabetes types when injected, but this new study shows the drug has promise as an oral treatment for the disease.

Type I diabetes (insulin dependent) is currently treated with daily injections of insulin, while type II (non-insulin dependent) is treated with drugs bearing undesirable side-effects – the authors note neither treatment is ideal.

The researchers aim to test the drug in humans in future work.

Honey effective in killing bacteria that cause chronic sinusitis

2008 Study posted for filing

Contact: Matt Daigle
newsroom@entnet.org
703-535-3754
American Academy of Otolaryngology – Head and Neck Surgery

New research released at world’s largest ENT meeting

Chicago, IL – Honey is very effective in killing bacteria in all its forms, especially the drug-resistant biofilms that make treating chronic rhinosinusitis difficult, according to research presented during the 2008 American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) Annual Meeting & OTO EXPO, in Chicago, IL.

The study, authored by Canadian researchers at the University of Ottawa, found that in eleven isolates of three separate biofilms (Pseudomonas aeruginosa, and methicicillin-resistant and -suseptible Staphylococcus aureus), honey was significantly more effective in killing both planktonic and biofilm-grown forms of the bacteria, compared with the rate of bactericide by antibiotics commonly used against the bacteria.

Given the historical uses of honey in some cultures as a homeopathic treatment for bad wound infections, the authors conclude that their findings may hold important clinical implications in the treatment of refractory chronic rhinosinusitis, with topical treatment a possibility.

Chronic rhinosinusitis affects approximately 31 million people each year in the United States alone, costing over $4 billion in direct health expenditures and lost workplace productivity. It is among the three most common chronic diseases in all of North America.

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Title: Effectiveness of Honey on S. aureus and P. aeruginosa Biofilms
Authors: Talal Alandejani, MD (presenter); Joseph G. Marsan, MD; Wendy Ferris, BSc, MLT, MSc; Robert Slinger; Frank Chan, PhD
Date: Tuesday, September 23, 2008, 8:00-9:30 am (all times CDT)

Information for the Media:

The AAO-HNSF Annual Meeting & OTO EXPO newsroom will be located in Room 265, Lakeside Level 2, McCormick Place Convention Center. Hours of operation: Saturday, September 20, 12 pm to 5 pm; Sunday – Tuesday, September 21 – 23, 7:30 am to 5 pm; and Wednesday, September 24, 7:30 am to 2 pm. The newsroom serves as a work space for credentialed members of the media and credentialed public relations staff. The newsroom is managed and staffed by the AAO-HNS Communications Unit. Please see the AAO-HNS website for media credentialing requirements for the event.

About the AAO-HNS

The American Academy of Otolaryngology – Head and Neck Surgery (http://www.entnet.org), one of the oldest medical associations in the nation, represents more than 12,000 physicians and allied health professionals who specialize in the diagnosis and treatment of disorders of the ears, nose, throat, and related structures of the head and neck. The Academy serves its members by facilitating the advancement of the science and art of medicine related to otolaryngology and by representing the specialty in governmental and socioeconomic issues. The organization’s vision: “Empowering otolaryngologist-head and neck surgeons to deliver the best patient care.”

Onsite Newsroom: 312-949-3470

Stanford researcher criticizes FDA plans to reduce oversight of off-label drug use: Pharmaceutial Free For All (No Rules)

Repost From April 2008

Contact: Rosanne Spector manishma@stanford.edu 650-725-5374 Stanford University Medical Center

STANFORD, Calif. – Proposed guidelines from the U.S. Food and Drug Administration would allow companies to market more drugs for unapproved uses and are a step in the wrong direction, said a researcher from the Stanford University School of Medicine.

In an editorial to be published in the April 3 issue of The New England Journal of Medicine, Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, criticized the draft guidelines, which are subject to public comment through April 21. They curtail the FDA’s already limited authority over the marketing of drugs for off-label uses, Stafford said.

While most people assume that the medicines prescribed by doctors in the United States have the FDA’s stamp of approval, that’s only partially true. The FDA approves drugs for specific purposes, but doctors can use drugs “off-label” for medical conditions not approved by the FDA.

Off-label prescribing for medical conditions not scrutinized during the FDA approval process is common. There’s nothing illegal about off-label prescribing, and in many cases it’s good medicine, said Stafford, who directs Stanford’s Program on Prevention Outcomes and Practices. As long as the FDA has approved a drug for one condition, physicians are free to prescribe it for anything.

Unfortunately, what’s known about the use of a drug for one situation may not apply to other clinical scenarios. Stafford pointed to the use of antidepressants in children and the use of antipsychotic medications for dementia as key examples.

“The FDA should not suddenly start telling physicians how to practice. Physician judgment is critical, especially when approved therapies have not succeeded. Off-label prescribing can be an important tool in such cases,” he said. “But in other cases, off-label prescribing has become first-line therapy even in the absence of strong evidence of benefits and safety. This is problematic.”

Stafford said these types of situations suggest the need for a better way to evaluate and regulate off-label drug use. Ideally, he said, a drug company would go back to the FDA with additional clinical studies and obtain supplemental approval for a new clinical use.

Off-label drug use is already common, but applications to the FDA for approval of new uses are uncommon, said Stafford. This process may be seen as irrelevant by drug manufacturers, who have strategies for expanding their off-label markets and boosting drug sales without formal FDA approval.

Although FDA regulations restrict drug manufacturers from overtly promoting their drugs for unapproved conditions, they are free to share educational materials with physicians, most often as published journal articles. According to current FDA guidelines, this practice is acceptable, but only if the manufacturer submits the articles to the FDA for review and is pursuing formal FDA approval for the new use. In reality, however, FDA enforcement is limited, said Stafford.

The new draft guidelines further pull back FDA involvement by eliminating both of these requirements. In addition, they reduce the remaining policies to non-binding recommendations.

This concerned Stafford, who wrote in the NEJM editorial: “The FDA may be conceding to drug manufacturers the responsibility for regulating their own off-label marketing practices. The agency may also believe that its limited resources can be put to better or more effective use in confronting other ongoing challenges. Nevertheless, I believe that the FDA must take an active role in fostering evidence-based practice, eliminating subversion of the approval process, and requiring a balanced and fair presentation of the scientific evidence.”

One of the proposed guidelines’ major pitfalls, said Stafford, would be allowing drug manufacturers to skip obtaining approval for potentially lucrative drug uses. Instead, companies might seek approval only for a narrower use that’s more easily and less expensively tested, and sponsor research on more commercially promising uses that are never evaluated by the FDA. Stafford warned that this might encourage widespread treatment of conditions with drugs never approved by the FDA for those purposes.

Off-label use is already burgeoning. In a 2006 examination of off-label prescribing of 160 common drugs, Stafford found that off-label use accounted for 21 percent of all prescriptions and 73 percent of these uses had little or no scientific support (Archives of Internal Medicine, May 8, 2006). Drugs approved for depression, schizophrenia and seizures were most likely to be used off-label without adequate support for other conditions.

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The FDA is accepting comments on the draft guidelines through April 21. Comments can be made online: Go to http://regulations.gov, search for the docket “FDA-2008-D-0053” and use the “send a comment” option.

Stanford University Medical Center integrates research, medical education and patient care at its three institutions – Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children’s Hospital at Stanford. For more information, please visit the Web site of the medical center’s Office of Communication & Public Affairs at http://mednews.stanford.edu.

Over-the-counter eardrops may cause hearing loss or damage

Contact: Lisa Dutton lisa.dutton@muhc.mcgill.ca 514-412-4307 McGill University Health Centre

The Montreal Children’s Hospital of the MUHC recommends these products be used with extreme caution

MONTREAL, Jan 28, 2008 — A new study, led by researchers at The Montreal Children’s Hospital (MCH) of the MUHC, has revealed that certain over-the-counter earwax softeners can cause severe inflammation and damage to the eardrum and inner ear. The results of the study, recently published in The Laryngoscope, suggest that use of these medications should be discouraged.

“Patients often complain that wax is blocking their ears and is causing discomfort and sometimes deafness,” says Dr. Sam Daniel principal investigator of the study and director of McGill Auditory Sciences Laboratory at The Children’s. “Over-the-counter earwax softeners are used to breakup and disperse this excess wax. However, the effects of these medications on the cells of the ear had not been thoroughly analyzed.”

“Because some of these products are readily available to the public without a consultation with or prescription from a physician, it is important to make sure they are safe to use. Our study shows that in a well-established animal model, one such product, Cerumenex, is in fact, toxic to the cells of the ear,” says Dr. Daniel.

Dr. Daniel and his team studied the impact of Cerumenex on hearing. In addition, overall toxicity in the outer ear and changes in the nerve cells of the inner ear were analyzed.

“Harmful effects to many of the cells were observed after only one dose,” says Dr. Melvin Schloss co-author and MCH Director of Otolaryngology. “We observed reduced hearing, severe inflammation, and lesions to the nerve cells.”

“We believe these findings are applicable to humans,” add Dr. Daniel. “The animal model we chose has been widely used to test toxicity. In addition, this model has a very similar hearing mechanism. Overall, our findings suggest that Cerumenex has a toxic potential and it should be used with caution.”

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The Montreal Children’s Hospital is the pediatric teaching hospital of the McGill University Health Centre (MUHC). The institution is a leader in the care and treatment of sick infants, children, and adolescents from across Quebec. The Montreal Children’s Hospital provides a high level and broad scope of health care services, and provides ultra specialized care in many fields including: cardiology and cardiac surgery; neurology and neurosurgery, traumatology; genetic research; psychiatry and child development and musculoskeletal conditions, including orthopedics and rheumatology. Fully bilingual and multicultural, the institution respectfully serves an increasingly diverse community in more than 50 languages. www.thechildren.com

For more information please contact: Lisa Dutton Manager, Public Relations and Communications MCH (514) 412-4307 lisa.dutton@muhc.mcgill.ca

 

Study shows long term effects of radiation in pediatric cancer patients

August 21, 2012  By

For many pediatric cancer patients, total body irradiation (TBI) is a necessary part of treatment during bone marrow transplant– it’s a key component of long term survival. But lengthened survival creates the ability to notice long term effects of radiation as these youngest cancer patients age. A University of Colorado Cancer Center study recently published in the journal Pediatric Blood & Cancer details these late effects of radiation.

 

“These kids basically lie on a table and truly do get radiation from head to toe. There is a little blocking of the lungs, but nothing of, for example, the brain or the kidneys,” says Jean Mulcahy-Levy, MD, research fellow at the CU Cancer Center and the paper’s first author.

 

Of 15 patients who received TBI before age 3, many developed endocrine and metabolic problems including testicular malfunction (78 percent), restrictive pulmonary disease due to high levels of blood triglycerides (74 percent), and cataracts (78 percent). Likewise, 90 percent of patients showed abnormally low levels of growth hormone, and 71 percent were considerably under height. Additional late effects of TBI included kidney, liver, skeletal and cardiac malfunction – and three of four patients whose IQ had been tested before TBI showed cognitive decline.

 

“Fifteen doesn’t seem like a large number, but because we have such a good pediatric bone marrow transplant program here at Children’s Hospital Colorado and radiation therapy program at the CU Cancer Center, we were able to get a large enough cohort of patients to see these overall effects,” Mulcahy-Levy says.

 

The study supports the recommendations of the Children’s Oncology Group for long term follow up care for children receiving TBI (survivorshipguidelines.org). Specifically, Mulcahy-Levy hopes that increasing awareness of likely effects will help patients and their doctors screen for, detect, and correct likely effects of TBI.

 

“It’s not so much that you want to stop TBI, which is frequently a necessary part of treatment, but this study shows it’s important know about these problems in order to address them appropriately and proactively,” Mulcahy-Levy says.

 

Support provided in part by a St. Baldrick’s Foundation Fellowship Award and by NIH/NICHD Child Health Research Career Development Award K12 HD068372

http://www.coloradocancerblogs.org/news/study-shows-long-term-effects-of-radiation-in-pediatric-cancer-patients

How much of the medical literature is shaped behind the scenes by drug companies?

Requested Repost

Citation: Sismondo S (2007) Ghost management: How much of the medical literature is shaped behind the scenes by the pharmaceutical industry” PLoS Med 4(9): e286

 

Drug companies control or shape multiple steps in the research, analysis, writing, and publication of a large proportion of the medical literature, and they do so behind the scenes, according to a policy paper in this week’s PLoS Medicine. The paper’s author, Sergio Sismondo (Queen’s University, Kingston, Canada), who is an expert in the philosophy of science, calls this phenomenon “ghost management.”

Such articles are “ghostly” says Dr Sismondo, “because signs of their actual production are largely invisible–academic authors whose names appear at the tops of ghost-managed articles give corporate research a veneer of independence and credibility.” Drug companies hire medical education and communication companies (MECCs) to help produce and place company-funded articles in medical journals, says Dr Sismondo.

These articles are “managed,” he says, because those MECCs “shape the eventual message conveyed by the article or by a suite of articles.” Dr Sismondo looks at one specific example—the published medical literature on the antidepressant drug sertraline.

His analysis suggests that between 18% and 40% of the literature on this drug published between 1998 and 2000 was ghost managed by a single MECC acting on behalf of the drug’s manufacturer. Ghost managed studies, says the author, “affect medical opinion, practice and ultimately, patients,” says Dr. Sismondo. “I suspect that most researchers – even those participating in the system – don’t have a good sense of the extent to which this happens.”

Citation: Sismondo S (2007) Ghost management: How much of the medical literature is shaped behind the scenes by the pharmaceutical industry” PLoS Med 4(9): e286

Radioprotection and extracts of Ginko biloba

Contact: Chang-Mo Kang kangcm@kcch.re.kr Inderscience Publishers

Herbal tonic for radiotherapy

Antioxidant extracts of the leaves of the Gingko biloba tree may protect cells from radiation damage, according to a study published in the International Journal of Low Radiation. The discovery may one day be used to help reduce side effects in cancer patients undergoing radiotherapy.

Chang-Mo Kang of the Korea Institute of Radiological and Medical Sciences in Taegu and colleagues are interested in the protective effects of well-known herbal remedies of which Gingko biloba is one. G. biloba is a unique tree species with no close living relatives and extracts of its leaves contain antioxidant compounds including glycosides and terpenoids known as ginkgolides and bilobalides.

These compounds are thought to protect cells from damage by free radicals and other reactive oxidizing species found in the body. These are generated continuously by the body’s normal metabolism, and in excess in some diseases or after exposure to pollution or radiation. They damage proteins, DNA and other biomolecules and left unchecked can kill cells.

As such, extracts of certain plants that contain antioxidants, including G. biloba, have attracted interest for their pharmacological activity. G. biloba is currently sold as a herbal supplement and there are numerous claims for health benefits, including the possibility of preventing the onset of dementia or Alzheimer’s disease.

Kang and colleagues have now collected human white blood cells, lymphocytes, from healthy donors aged 18 to 50 years. They treated half of these cells with commercially available G. biloba extract in the laboratory and doused the other half with salt solution as an experimental control. They then compared the effects of gamma radiation from radioactive cesium on the white blood cells compared to the untreated control samples.

The team uses a light microscope to look for lymphocytes undergoing programmed cell death, or apoptosis, as a result of radiation exposure. They found that there was a significant increase in apoptosis in the untreated cells compared with those treated with G. biloba extract. Almost a third of the untreated cells underwent apoptosis compared with approximately one in twenty of the treated cells. Parallel studies with laboratory mice also demonstrated a similar protective effect against radiation poisoning.

The results suggest that the extracts can neutralize the free-radicals and oxidizing agents produced in the cells by the radiation and so prevent them from undergoing apoptosis.

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“Protective effect of Gingko biloba against radiation-induced cellular damage in human peripheral lymphocytes and murine spleen cells” in Int. J. Low Radiation, 2009, 6, 209-218

* Reposted for Filing

Experts challenge FDA over approval for new dose of Alzheimer’s drug – Aricept ( donepezil ) Ineffective and harmful

Observations: How the FDA forgot the evidence: The case of donepezil ( Aricept) 23 mg

Approval for a new dose of a best-selling Alzheimer’s drug “breached the FDA’s own regulatory standard” and has led to “incomplete and distorted messages” about the drug, warn experts on bmj.com today.

In the first of a new occasional series, “not so”, highlighting the exaggerations, distortions, and selective reporting that mark some news stories, advertising, and medical journal articles, Lisa M. Schwartx and Steven Woloshin challenge the claims made for the new 23 mg dose of donepezil.

Professors Lisa Schwartz and Steven Woloshin of the Center for Medicine and the Media at The Dartmouth Institute for Health Policy and Clinical Practice argue that the new dose was approved “only over the objections of the FDA’s medical and statistical reviewers” and that it offers “no meaningful added benefit, just more harm.”

Donepezil was a blockbuster drug for Alzheimer’s disease, with over $2bn in annual sales in the United States alone. Just before its patent expired, the US Food and Drug Administration (FDA) approved a new 23 mg dose for moderate to severe Alzheimer’s disease, thereby extending its patent for three more years. Previously, the drug was only available in 5 mg and 10 mg doses.

The FDA and the manufacturer agreed that the 23 mg dose would be approved only if it was shown to be superior to the 10 mg dose on both a cognitive and a global functioning measure.

Although the drug improved cognitive symptoms, it did not improve overall functioning, which suggests that the cognitive difference was not meaningful. Furthermore, the new dose caused more side effects, including nausea and vomiting.

Yet Schwartz and Woloshin point to “a stunningly erroneous statement” in an advertisement aimed at doctors which claims that patients on the 23 mg dose “experienced important clinical benefit on both measures [cognition and overall functioning].”

“Nowhere – not in the direct to consumer or the physician advertisements, nor even in the FDA approved label – are the great uncertainties about this drug acknowledged, uncertainties that led the FDA’s own medical and statistical reviewers to recommend against approval of the 23 mg dose,” they argue.

Despite this, the drug was approved over the objections of the FDA’s medical and statistical reviewers and government and private insurance programmes now cover the drug. It is now, or will soon be under consideration for approval in 16 countries in Asia and South America.

Alzheimer’s is an awful disease, say the authors. “Sadly, the available drugs don’t work well. But that is no excuse for manipulating vulnerable patients, desperate family members, and their doctors to use a product that is most likely to cause net harm.”

They conclude: “To make good decisions about drugs, doctors and patients need the evidence. The FDA should not forget to give it to them.”

New material recently obtained by the authors from the FDA acknowledge that they made an error in relation to the previous label, stating: “The offending phrase was in the original label, and we don’t recall how it slipped by, but we contacted the company as soon as it was brought to our attention, and they readily agreed to remove it. We are always inter­ested in improving the content and clarity of our labeling, and appreciate being informed of any misleading or inaccurate statements that anyone may notice.”

JAMA editor-in-chief comments on Pfizer lawsuit

In an editorial published early online today, JAMA Editor-in-Chief Catherine D. DeAngelis, M.D., M.P.H., and JAMA Editorial Counsel Joseph P. Thornton, J.D., write about a recent court ruling regarding litigation involving JAMA and the Archives of Internal Medicine (AIM) “that significantly threatened the integrity of our peer review process.”

Attorneys for the pharmaceutical company Pfizer, Inc. had issued subpoenas last year to obtain confidential information from the journals concerning studies published on the pain relief medications called COX-2 inhibitors – (cyclooxygenase 2 inhibitors) celecoxib and valdecoxib.

“… the subpoenas sought all documents regarding the decision to accept or reject manuscripts, copies of rejected manuscripts, the identities of peer reviewers and the manuscripts they reviewed, and the comments by and among peer reviewers and editor regarding manuscripts, revisions, and publication decisions. For months, JAMA and AIM consistently argued that the sanctity of the confidential peer review process should not be violated.”

“In a ruling issued March 14, 2008, the Court agreed with JAMA and AIM that information kept confidential from Pfizer, the general public, and the medical community at large was irrelevant to the pending claims.”

“… JAMA and our Archives journals have historically and deliberately kept unpublished manuscripts and peer review comments confidential. This promise to reviewers and authors allows the peer review process to work in an unrestrained environment.”

“The subpoenas attempted to invade the peer review process, and we are delighted that Magistrate Judge Keys said so when he ruled they could not be enforced against us.”

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The editorial has been published early online because of its timeliness and importance.  It will appear in the April 23/30, 2008, print issue of JAMA.

JAMA. (doi:10.1001/jama.299.16.jed80000.)   Available online at www.JAMA.com.

No financial disclosures reported.