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FDA Questions Benefit of Amgen Bone Drug in Certain Cases

Sean Duffy — Mon, 06 Feb 2012 18:20:21 +0000

The Food and Drug Administration questioned the clinical benefit of using Amgen’s bone drug Xgeva to prevent or delay the spread of prostate cancer to the bones. Xgeva is currently approved to delay fractures and other bone injuries in patients whose cancers have already spread to the bones. The company is seeking approval for use of Xgeva to prevent the spread of prostate cancer in a group of men that has not responded to other therapies. Xgeva will be reviewed Wednesday by the FDA’s oncologic drugs advisory committee, which is made up of non-FDA medical experts. The FDA today posted a review of Xgeva in preparation for the meeting. Amgen conducted a study of Xgeva in 1432 men with prostate cancer that had not responded to previous therapies, but had not spread to the bones. Many types of cancer spread to the bones and cause tumors to grow, destroying the bone around the tumor, causing fractures and other problems. Half of the men were treated with Xgeva while the other half received a placebo. The study examined the time until men developed bone metastases or died, whichever occurred first. The study showed Xgeva prolonged median bone metastatis-free survival by 4.2 months compared to men in the placebo group. While the FDA said the study met its primary objective, the agency said it was unclear whether the results were “clinically meaningful” given that there was no difference in overall survival between the two patient groups. The agency said the risk-benefit ratio of Xgeva must also take into account the overall toxicity of the drug. One of the side-effects includes a risk of developing osteonecrosis of the jaw, or ONJ, a rare jaw-decay problem. Michael Severino, Amgen’s vice president of research and development, said today that the company believes Xgeva does provide a clinically meaningful benefit because it delays the spread of cancer to the bone, which causes significant pain and other problems such as incontinence. Xgeva is also sold under the brand name Prolia as an osteoporosis treatment but is administered at a lower dose and less often than used to treat cancer-related bone complications. Xgeva and Prolia’s combined sales in 2011 topped $550 million. The drugs target a protein called RANK Ligand, which helps regulate cells called osteoclasts that break down bone. (This post originally ran on Dow Jones Newswires.)

HPV Cancer and the Male Gender

Martin Neumann — Thu, 02 Feb 2012 15:31:25 +0000

Oral HPV infection is much widely found amongst men than women and this explains why men are more prone to develop HPV cancer related to neck and head. This study was presented at Multidisciplinary Neck and Head Cancer Conference. Currently HPV or known as Human Papillomavirus was linked to various kinds of neck and head Related posts: Virus That Cause Cervical Cancer, Responsible for Oral Cancer, Too Before, smokers and drinkers worry having prolonged sore throat due… Male Breast Cancer, More Life Threatening Males can be afflicted with breast cancer, although it is… Grape Seed Extract Kills Cancer Cells As per a research report, it was reported that 12,000…

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HPV Cancer and the Male Gender

What Massage Really Does to Your Muscles

Dr Joe — Wed, 01 Feb 2012 21:26:40 +0000

Why get a massage? Well, because it feels good, for one thing. But many people also hop on the table with the hope that massage therapy can help promote muscle recovery after a tough workout or provide other benefits. No one has looked closely at what massage does to muscle at a cellular or molecular level, however. Researchers set out to do just that, and their findings are published in Science Translational Medicine . The researchers exercised 11 young men to exhaustion over about 70 minutes, then massaged a single leg (determined randomly for each man) for ten minutes. The subjects received a muscle biopsy in both quad muscles to gather samples for massaged and non-massaged legs. The biopsy was repeated after a 2.5-hour rest period. Researchers analyzed the samples from the different legs to see what was going on after the massage. They found two major changes: reduced signs of inflammation, and an increase in production of mitochondria, the cell’s energy factories. Curbed production of inflammatory molecules “may reduce pain by the same mechanism as conventional anti-inflammatory drugs” like aspirin and ibuprofen, the authors write. The authors say that an increase in the number of mitochondria can promote better recovery after a tough exercise session. That finding also means that massage after exercise could help enhance endurance, says Mark Tarnopolsky, an author of the study and a professor of pediatrics and medicine at McMaster University Medical Center in Hamilton, Ont. Nailing down that link would require further research, says Tarnopolsky. The study didn’t turn up any signs that massage flushes out lactic acid from the muscle, he says. Image: iStockphoto

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What Massage Really Does to Your Muscles

Informed Patient: Taking Quality of Life into Account in Health Decisions

Sean Duffy — Tue, 31 Jan 2012 14:44:41 +0000

Quality-of-life questions are becoming increasingly important in medical care, especially when it comes to helping patients make decisions about treatments, today’s Informed Patient column reports . Since the 1970s, researchers have been using quality-of-life measurement tools for a wide variety of medical conditions, primarily in population studies and clinical trials. Outside the U.S. they are often used by national medical systems to help determine payment policies for more costly drugs or treatments. But there is growing interest in using such tools in the clinic — or at least getting doctors to more routinely ask patients how their disease or treatment is affecting their life. “Understanding a patient’s experience and the effects of his or her condition on well-being is crucial to a good or quality clinical encounter, especially for chronic conditions,” University of California, San Francisco dermatology professor Margaret Chren tells the Health Blog. Chren is a developer of one of the most popular quality-of-life measurement tools in dermatology, Skindex . While not routinely used in clinical care, Skindex is used in a number of research studies. (Potential users must apply to the MAPI Research Trust .) In one study , for example, Chren and colleagues used Skindex to compare quality-of-life outcomes for different treatments for removal of skin cancers. In the study, two treatments — the surgical procedure known as Mohs surgery as well as excision — resulted in improved quality-of-life scores for patients compared to a treatment that involved burning and scraping off lesions. Because clinical encounters are often brief, Chren says, the focus is often on easily measured and assessed features such as lab or X-ray results. And reimbursement incentives don’t encourage long talks with patients that might uncover quality-of-life concerns. Some providers are offering the surveys to patients before doctor visits, and health systems are increasingly incorporating surveys and questionnaires into electronic medical records. Jim O’Connor, marketing director of QualityMetric, whose surveys are already widely used in research and public health programs, says the company has seen rapid growth in their use in clinical settings. The company offers an online system, Smart Measurement , that instantly scores quality-of-life questionnaires so doctors can refer to them during appointments with patients. At Dartmouth-Hitchcock Medical Center, which uses surveys from QualityMetric in clinical care, researchers are also developing their own quality measurement tools including one that uses a “feeling thermometer” to compare how doctors and their patients perceive the impact of Crohn’s disease, an inflammatory bowel condition, on health-related quality of life. A study published in 2010 found that two questions using the feeling thermometer provide a quick and accurate assessment of the burden of the disease on patients, and that physicians’ perceptions of the burden of disease was similar to that of their patients. Gastroenterologist Corey Siegel , a co-author of the study, says he is eager to get the tool into practice. For patients, while the “burden of symptoms” may go down, the “burden of treatment” — including routine lab tests, frequent colonoscopies, regular injections or IV infusions and 20 or more pills a day — might go up. “The ideal is a low burden of symptoms and treatment, but realistically there are trade-offs that need to be made,” Siegel says. “The optimum use of this tool would be for patients to track the burden of symptoms and treatment so that their providers can understand how they are really doing overall as opposed to focusing on symptoms alone — which is only part of their experience with chronic disease.” Many of the quality-of-life questionnaires can be found online or through disease advocacy groups. Bruce Bebo, director of research and medical programs at the National Psoriasis Foundation, suggests that patients whose doctors don’t offer quality-of-life questionnaires can review and answer survey questions like the ones it uses for its own research (via the Koo-Mentor Psoriasis Instrument ) to help them think about the issues and bring them up at the next doctor’s visit. “They may be surprised to learn how much the disease affects their quality of life,” says Bebo.

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Informed Patient: Taking Quality of Life into Account in Health Decisions

Brown Fat, the Cold, and You: How to Make Your Fat Burn Calories

Martin Neumann — Mon, 30 Jan 2012 11:33:54 +0000

Not all body fat is created equal, at least according to two new studies reported by the New York Times last week. One study found that brown fat burns calories “like a furnace” when you’re cold, and another found that regular white fat can be converted into calorie-burning brown fat while you exercise. The first study found that brown fat burns glucose as well as other stores of fat when its own are depleted in order to keep the study participants warm. The other study found that in mice exercise creates a hormone that may be turning those dangerous white fat stores into fuel-burning brown fat. These studies aren’t the first to identify the seemingly magical properties of brown fat. Brown fat has been known for years to be a calorie-torching element found mostly in those who are leaner, younger, or women (compared to older or obese people or men). More research is necessary to see just how brown fat can help promote weight loss, but even so, by making a few simple changes you can take advantage of the findings. How can you possibly increase your own store of brown fat? Read on for some metabolism-boosting tips.

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Brown Fat, the Cold, and You: How to Make Your Fat Burn Calories

Leukemia Cells Toxic To Bones

Sean Duffy — Sat, 28 Jan 2012 15:57:23 +0000

Researchers from the University of Rochester Medical Centre have now found new connections between the leukemia cells and the cells which are involved in the formation of bones. This study has offered a fresh approach to how the blood cancer progresses and raises the probability that therapies for the bone disorders can help in curing Related posts: Possible Cure for Leukemia Found in the Form of Fish Oil There are certain diseases that up to this date, cure… Stem Cells for Heart Damage Treatment, Still A Challenge Improvements in technology have been very significant not only in… Smokes from Parents: Have a Bearing on Leukemia Risk of Children The time when the unborn infant is still in the…

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Leukemia Cells Toxic To Bones

Religion and Self Control: How One Helps the Other

Martin Neumann — Thu, 26 Jan 2012 15:27:45 +0000

A study conducted by Queen University proved that thinking about one’s religion helped them gain self control on later. After the unscrambled sentences which contained religiously oriented words, individuals engaged in this study experienced more self control, says lead researcher and psychology graduate student Kevin Rounding who worked on the study. The individuals were given Related posts: Birth Control Acne, Effects of Birth Control – BIRTH CONTROL QUESTIONS Birth control acne There are several brands that help clear… How The Brain Perceives Images and Relate Words Many of us believe that whatever things we perceive in… Green leafy vegetables helps in reducing risk of diabetes Recently British Medical Journal had published that eating very large…

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Religion and Self Control: How One Helps the Other

Pacifying Your Boss Through Exercise

Sean Duffy — Thu, 26 Jan 2012 15:27:37 +0000

As per a new study from Northern Illinois University which was conducted by James Burton it is proved that the supervisors who are stressed and who struggle with time pressure voice their frustration of their subordinates or employees. But they do this less if they moderately exercise on regular basis. This research got published in Related posts: Who’s To Blame for an Unhappy Career? As per a new research by Dr. Nicolas Gillet, who… How to Exercise While Sitting at Your Desk : EXERCISE TIPS Exercising while sitting at the desk is very important because… How Does Exercise Fit the Elderly People The elderly population is considered as one of the most…

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Pacifying Your Boss Through Exercise

A $25,000 Challenge to Make Sense of Genetic Information

Dr Dreams — Tue, 24 Jan 2012 16:45:42 +0000

Genome sequencing is poised to get even cheaper — perhaps costing as little as $1,000 by the end of the year, as the WSJ recently reported . But being able to bang out a patient’s genome relatively inexpensively and quickly — Life Technologies says it expects to soon be able to deliver that information in a day — is only the starting point. There are challenges “at all levels of interpreting whole genomes from measurement all the way to the final clinical report,” says Isaac Kohane , a professor of pediatrics at Children’s Hospital Boston. He is one of the organizers of the CLARITY Challenge, the hospital’s newly announced $25,000 competition to encourage scientific teams to develop standards for analyzing, interpreting and reporting relevant genomic findings to physicians and patients. Genome analysis is “an exciting technology” and has “come into practical fruition in the last couple of years, but a lot of work needs to be done to make it usable in a clinically responsible fashion,” says Kohane. Competition participants will get de-identified genome sequences (from Life Technologies and Complete Genomics, which are sponsors of the challenge) and clinical summaries covering three children and their families. The children all have a rare disease with a suspected genetic component, says Kohane. The teams will aim to get from that data to the root cause of the disease, and to present their findings in a clinically meaningful report — to “assemble all these pieces in a fairly complex process,” says Kohane. An expert panel will judge the entries. Registration is now open and ends March 1; the winner will be announced in October. Kohane says the families will be given any useful information uncovered during the competition, such as information pointing to care or treatment options. “We were as sober as we could be” in telling the families how likely that is, he says. “There is no way of knowing the odds on that.” But, he adds, “it would be very, very nice if we could help these families.” As the WSJ has reported , Children’s Hospital Boston broke with convention when it designed a genetic research project so that information gleaned from patient and family DNA could potentially benefit the study participants, not just science. Bonus: Genomics Won’t Lead to Big Health-Care Improvements ‘For Many Years’

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A $25,000 Challenge to Make Sense of Genetic Information

Some Promising Findings on Embryonic Stem Cells

Dr Joe — Mon, 23 Jan 2012 22:02:28 +0000

Very early results from research into embryonic stem cell treatments suggest that the therapy was safe in use against macular degeneration, a major cause of blindness. The findings, though preliminary, are the first published results involving embryonic stem cells in human patients. In the report, which covered two patients followed over four months, the patients reported some visual improvement that may — or may not — spring from the treatment. But much more research needs to be done before the therapy can be deemed a success. Writing in the Lancet , researchers from biotech firm Advanced Cell Technology and the University of California, Los Angeles reported turning human embryonic stem cells into the key cells lost in macular degeneration, known as retinal pigment epithelial cells. Two legally blind patients then had these cells surgically implanted into one eye. The patients — one with dry age-related macular degeneration and one with a related condition called Stargardt’s macular dystrophy — showed no signs of the safety problems that have been a concern about embryonic-stem-cell-derived therapies. “There were no tumors, and there was no immune rejection” after patients were tapered off of immunosuppressive drugs, said Steven Schwartz , an author of the study and chief of the retina division at UCLA’s Jules Stein Eye Institute. The patients also reported visual changes that “could be a sign of improvement,” said Dr. Schwartz. For instance, the Stargardt’s patient, in her 50s, went from discerning only hand motions to being able to count fingers. She also reported improved color vision. But Dr. Schwartz cautioned that the improved vision reported by the patients might be chalked up to the placebo effect, the surgery, the immunosuppressive drugs or “all of the above,” he said. “Objectively, there is no consensus in how to measure vision in low-vision patients,” he said. The clinical trials studying the drugs in the two different forms of macular degeneration will eventually include 24 patients at different centers, followed intensively for a year and then tracked for years afterwards, said Robert Lanza , an author of the study and chief scientific officer at Advanced Cell Technology, which is developing the therapy and funded the research. He said if studies in these patients with advanced disease pan out, eventually the aim is to target patients at much earlier stages of macular degeneration. Dr. Lanza said even limited data from two patients is “of great value to the scientific community” because of the safety concerns that have surrounded embryonic stem cell research. The research has also been controversial for ethical reasons, given that the extraction of stem cells from a human embryo results in the destruction of the embryo, which some critics say amounts to taking human life. Stem cells can develop into any kind of tissue. The research is difficult and resource-heavy. Another company, Geron Corp. said in November it would exit the entire field of embryonic stem cell research, citing financial constraints. As part of that move, it halted a small trial of embryonic stem cells in people with spinal-cord injuries. That study had been the first trial of the technology to be approved in humans. Dr. Lanza said this work also “paves the way” for working with so-called induced pluripotent stem cells, adults cells taken from the patient and reprogrammed back to an earlier state. Those have the benefit of avoiding the ethical issues surrounding embryonic cells as well as the prospect of rejection by the body. Image of embryonic stem cells via NIH Image Bank

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Some Promising Findings on Embryonic Stem Cells