Treatment for Painful Curved Penis Shows Promise

Xiaflex up for FDA approval later this year, but some experts think injections required would be a tough sell

By Barbara Bronson Gray

HealthDay Reporter

WEDNESDAY, May 8 (HealthDay News) -- Some diseases are especially tough to discuss.

When Tony Lee realized that his penis was curving whenever he had an erection -- making it painful and difficult for him to have sex -- he had no idea what was wrong. He became depressed and very worried, and his relationship with his wife started to change.

"For a man to dread sex, it's just not natural," he said. "There were times when I would stay up late on purpose, just to make sure my wife was sleeping before I got into bed. I was just totally embarrassed."

His wife finally convinced him to see his primary care physician, who referred him to a urologist. The specialist told him he had Peyronie's disease, a connective tissue disorder involving the growth of fibrous collagen plaques in the soft tissue of the penis. The condition can cause pain, erectile dysfunction and shortening of the penis.

The diagnosis was difficult to face.

"You do freak out. It's such a personal area. It's like, 'Noooooo! Why couldn't I just lose a finger? Anything but this,'" said Lee, who is 46. Lee asked that his full name not be used.

Experts estimate Peyronie's disease, a connective tissue disorder, affects at least 5 percent of men. Although the cause of the disorder is not known, physicians think genetic predisposition and repetitive minor trauma to the penis during sexual activity may play a role. People with diabetes, and those who have had prostate cancer surgery or erectile dysfunction, are also susceptible to the disease, according to Dr. Larry Lipshultz, a professor of urology at Baylor College of Medicine.

The treatment options are very limited, and there is no cure. "There is no oral or topical medication," said Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital, in New York City. "You can excise the plaque and tighten up the other side, but that reduces the length, or you can use a penile prosthesis."

Lipshultz said he's had some luck with about half of his patients when he gives them a drug called verapamil, a calcium channel blocker, which is injected into the shaft of the penis. The use of the drug is based on its ability to degrade collagen, slowing, preventing or even reversing plaque formation and the progression of Peyronie's disease, according to a 2002 study published in the International Journal of Impotence Research. A verapamil gel that is applied to the skin is also sometimes used, according to Kavaler.

Lee, who has been dealing with Peyronie's for about two years, has used a "straightening machine" that stretches the penis, and he participated in one of two clinical trials for a new drug that is up for review by the U.S. Food and Drug Administration: Xiaflex, produced by Auxilium Pharmaceuticals Inc. He said his penis is now 70 percent of its pre-disease length as a result of the interventions.

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Treatment for Painful Curved Penis Shows Promise

By Barbara Bronson Gray
HealthDay Reporter

WEDNESDAY, May 8 (HealthDay News) -- Some diseases are especially tough to discuss.

When Tony Lee realized that his penis was curving whenever he had an erection -- making it painful and difficult for him to have sex -- he had no idea what was wrong. He became depressed and very worried, and his relationship with his wife started to change.

"For a man to dread sex, it's just not natural," he said. "There were times when I would stay up late on purpose, just to make sure my wife was sleeping before I got into bed. I was just totally embarrassed."

His wife finally convinced him to see his primary care physician, who referred him to an urologist. The specialist told him he had Peyronie's disease, a connective tissue disorder involving the growth of fibrous collagen plaques in the soft tissue of the penis. The condition can cause pain, erectile dysfunction and shortening of the penis.

The diagnosis was difficult to face.

"You do freak out. It's such a personal area. It's like, 'Noooooo! Why couldn't I just lose a finger? Anything but this,'" said Lee, who is 46. Lee asked that his full name not be used.

Experts estimate Peyronie's disease, a connective tissue disorder, affects at least 5 percent of men. Although the cause of the disorder is not known, physicians think genetic predisposition and repetitive minor trauma to the penis during sexual activity may play a role. People with diabetes, and those who have had prostate cancer surgery or erectile dysfunction, are also susceptible to the disease, according to Dr. Larry Lipshultz, a professor of urology at Baylor College of Medicine.

The treatment options are very limited, and there is no cure. "There is no oral or topical medication," said Dr. Elizabeth Kavaler, an urologist at Lenox Hill Hospital, in New York City. "You can excise the plaque and tighten up the other side, but that reduces the length, or you can use a penile prosthesis."

Lipshultz said he's had some luck with about half of his patients when he gives them a drug called verapamil, a calcium channel blocker, which is injected into the shaft of the penis. The use of the drug is based on its ability to degrade collagen, slowing, preventing or even reversing plaque formation and the progression of Peyronie's disease, according to a 2002 study published in the International Journal of Impotence Research. A verapamil gel that is applied to the skin is also sometimes used, according to Kavaler.

Lee, who has been dealing with Peyronie's for about two years, has used a "straightening machine" that stretches the penis, and he participated in one of two clinical trials for a new drug that is up for review by the U.S. Food and Drug Administration: Xiaflex, produced by Auxilium Pharmaceuticals Inc. He said his penis is now 70 percent of its pre-disease length as a result of the interventions.

Xiaflex, which breaks down the scar tissue that is a component of penile plaque, was approved by the FDA in 2010 to treat Dupuytren's contracture, an inherited connective tissue disorder that causes the fingers to bend toward the palm. The concept of using Xiaflex with Peyronie's is based on some common features of both diseases. The hand condition is caused by an abnormal buildup of a substance called collagen. Fingers begin to bend toward the palm and the patient cannot straighten them.

The two clinical trials designed to test how Xiaflex worked in people with Peyronie's disease -- done in 2011 and 2012 -- together involved a total of 551 patients who received Xiaflex and 281 who were given a placebo. Each participant received four to six injections with a small needle into the penis every 25 to 72 hours over a period of several weeks. "The results showed people got a 30 percent improvement in curvature, which is clinically significant in terms of function," Lipshultz said

Recent data on the treatment appeared online in February and will be published in the July print issue of the Journal of Urology.

Lipshultz, who was involved in the clinical trials and is paid by Auxilium to speak to physicians about the treatment, said the company thinks Xiaflex will be approved by the FDA by mid-September.

Yet, Kavaler expressed concerns about whether Xiaflex will be helpful.

"The data show it looks like the drug made people feel better about their condition, maybe because they were getting treatment in the clinical trial, but I'm not sure if functionally it made a big difference," she said. "I don't think I could convince somebody to let me inject their penis four to six times with the hope of getting some small improvement."

Side effects from the injection of the drug included: bruising, swelling and pain. There were also three serious adverse events involving penile fracture and three hematomas, according to Auxilium Pharmaceuticals.

But Lee is hopeful.

"I was so far gone with this, the curvature was so bad, and so I feel a whole lot better about myself now," he said. "It's kind of like if a person was paralyzed, and then all of a sudden you can walk, even though you might need assistance, it's a wonderful thing. That's how I'm looking at it."

Lee encouraged people to involve their partners to help them deal with the disease. "If there is a significant other in your life, you guys need to come together with this. For me, that made all the difference."

Copyright © 2013 HealthDay. All rights reserved. SOURCES: Larry Lipshultz, M.D., professor, urology, and chief, division of male reproductive medicine and surgery, Baylor College of Medicine, Waco, Texas; Elizabeth Kavaler, M.D., urologist, Lenox Hill Hospital, New York City; Tony Lee, Georgia; April 23, 2013, press release, Auxilium Pharamacuticals

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Drug Shows Some Benefit for Kids With Autism

By Kathleen Doheny
HealthDay Reporter

WEDNESDAY, May 1 (HealthDay News) -- An experimental drug for autism did not improve levels of lethargy and social withdrawal in children who took it, but it did show some other benefits, a new study finds.

Children on arbaclofen did improve on an overall measure of autism severity when compared to kids taking an inactive placebo, said lead researcher Dr. Jeremy Veenstra-VanderWeele, an associate professor of psychiatry, pediatrics and pharmacology at Vanderbilt University.

He is to present the findings Thursday at the International Meeting for Autism Research (IMFAR) in Spain.

One of 88 children in the United States is now diagnosed with an autism spectrum disorder, the umbrella term for complex brain development disorders marked by problems in social interaction and communication.

Veenstra-VanderWeele focused on evaluating the social improvement with the drug because earlier research had suggested it could help. However, one of the earlier studies did not compare the drug to a placebo, but simply measured improvement in those who took the drug.

In the new study, Veenstra-VanderWeele and his team assigned 150 people with autism, aged 5 to 21, to take the medicine or a placebo, without knowing which group they were in, for eight weeks. The participants had been diagnosed with autistic disorder, Asperger's syndrome or another related condition known as pervasive developmental disorder.

In all, 130 finished the study. When no differences were found in social withdrawal or lethargy between the two groups, the researchers looked at a scale that measures severity and improvement of autism with treatment.

Those on the drug improved more on that scale. A child, for instance, who began the study evaluated as having marked severity might be described as moderate by the study's end, Veenstra-VanderWeele said.

"This is the sort of improvement that would motivate us to start a medicine," he said.

The drug is believed to work, Veenstra-VanderWeele said, by increasing inhibition, improving social functioning and interactions.

Right now, Veenstra-VanderWeele said, "there is no medication that has clear evidence to improve social function in autism."

Those on the drug did report side effects, including suicidal thoughts reported by one patient on the drug and one on the placebo. Some patients on the drug became upset more easily; others reported sleepiness.

The next phase of trials of the drug are in the planning stages, Veenstra-VanderWeele said.

But more research is needed, said Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at the Steven and Alexandra Cohen Children's Medical Center of New York.

Even though the expected benefit did not materialize, Adesman sees a reason to continue to study the medication. "There is [still] some suggestion of benefit from the medicine," Adesman said. "It just didn't quite show up where they expected."

The drug may offer benefit to some children with autism, Adesman said. "But it's unclear which children may be the best candidates."

The trial received funding from the drug's maker, Seaside Therapeutics. The medication is not currently approved by the U.S. Food and Drug Administration.

The data and conclusions of research presented at medical meetings should be viewed as preliminary until published in a peer-reviewed journal.

Copyright © 2013 HealthDay. All rights reserved. SOURCES: Jeremy Veenstra-VanderWeele, M.D., associate professor, psychiatry, pediatrics and pharmacology, Vanderbilt University School of Medicine, Nashville, Tenn.; Andrew Adesman, M.D., chief of developmental and behavioral pediatrics, Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park, N.Y.; May 2, 2013, presentation, International Meeting for Autism Research (IMFAR), San Donostia/San Sebastian, Spain

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At-Home Drug Errors Common for Kids With Cancer, Research Shows

Study author says parents need more support, better awareness

By Steven Reinberg

HealthDay Reporter

FRIDAY, May 3 (HealthDay News) -- Children with cancer often have complex medication regimens -- sometimes as many as 20 drugs a day -- that they take at home, and mistakes are common, a new study finds.

Errors often occur when parents don't understand how to give the drugs, but mislabeled bottles and wrong prescriptions are also to blame, researchers say.

"Parents of children with cancer make many mistakes giving their children critical medicines, including chemotherapy at home," said lead researcher Dr. Kathleen Walsh, of the departments of pediatrics and medicine at the University of Massachusetts School of Medicine in Worcester.

Injuries were often related to under-dosing pain medication, which was causing pain for the children, she said. "Sometimes parents wouldn't fill prescriptions, or give the proper dose," Walsh said.

"One thing that was surprising was the high rate of errors that go on," she added. "This high rate of errors calls us to remind doctors and parents that they need to be aware that home medication use is fraught with error, so they need to give the medicines exactly as they are told to do."

That's not to blame parents, Walsh noted. "Usually parents weren't aware they were making mistakes. They weren't aware that what they were doing could be dangerous or could decrease the effectiveness of the medications they were using," she said.

Parental "workarounds" to get kids to take medicines could make them less effective.

For example, one child wouldn't take a chemotherapy drug, so the parent sprinkled it on his dinner not realizing the drug doesn't work when taken with food, Walsh said.

"Another parent wasn't using a pill cutter, but using a knife to cut the medication and so the chemotherapy was crumbling and much of it was left on the table," she explained. "Parents didn't realize this was a mistake."

Walsh thinks parents need more support in how they use medications at home. "Parents need to understand you need to give medications exactly as prescribed and if you are going to change that in any way you need to tell the doctor," she said.

The report was published in the May print issue of Pediatrics.

Dr. Len Lichtenfeld, deputy chief medical officer at the American Cancer Society, said that "when you are caught in the middle of the chaos and sadness of a sick child, it's not uncommon to see significant mistakes made when [parents are] giving medications to their children."

Many of the parents in the study were college educated, but no matter how well-educated the parents there are still many gaps in understanding how to administer chemotherapy at home, he said.

Lichtenfeld noted that these errors weren't always the parent's fault. "There were discrepancies between the labels on the drug and what the parents were supposed to do," he said. It's possible that the doctor changed the dose, but it was not reflected in the label from the pharmacy. This problem could be solved by better labeling, he added.

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Drug Shows Some Benefit for Kids With Autism

Study found no gains in lethargy, social withdrawal, but those on the drug improved in other ways

By Kathleen Doheny

HealthDay Reporter

WEDNESDAY, May 1 (HealthDay News) -- An experimental drug for autism did not improve levels of lethargy and social withdrawal in children who took it, but it did show some other benefits, a new study finds.

Children on arbaclofen did improve on an overall measure of autism severity when compared to kids taking an inactive placebo, said lead researcher Dr. Jeremy Veenstra-VanderWeele, an associate professor of psychiatry, pediatrics and pharmacology at Vanderbilt University.

He is to present the findings Thursday at the International Meeting for Autism Research (IMFAR) in Spain.

One of 88 children in the United States is now diagnosed with an autism spectrum disorder, the umbrella term for complex brain development disorders marked by problems in social interaction and communication.

Veenstra-VanderWeele focused on evaluating the social improvement with the drug because earlier research had suggested it could help. However, one of the earlier studies did not compare the drug to a placebo, but simply measured improvement in those who took the drug.

In the new study, Veenstra-VanderWeele and his team assigned 150 people with autism, aged 5 to 21, to take the medicine or a placebo, without knowing which group they were in, for eight weeks. The participants had been diagnosed with autistic disorder, Asperger's syndrome or another related condition known as pervasive developmental disorder.

In all, 130 finished the study. When no differences were found in social withdrawal or lethargy between the two groups, the researchers looked at a scale that measures severity and improvement of autism with treatment.

Those on the drug improved more on that scale. A child, for instance, who began the study evaluated as having marked severity might be described as moderate by the study's end, Veenstra-VanderWeele said.

"This is the sort of improvement that would motivate us to start a medicine," he said.

The drug is believed to work, Veenstra-VanderWeele said, by increasing inhibition, improving social functioning and interactions.

Right now, Veenstra-VanderWeele said, "there is no medication that has clear evidence to improve social function in autism."

Those on the drug did report side effects, including suicidal thoughts reported by one patient on the drug and one on the placebo. Some patients on the drug became upset more easily; others reported sleepiness.

The next phase of trials of the drug are in the planning stages, Veenstra-VanderWeele said.

But more research is needed, said Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at the Steven and Alexandra Cohen Children's Medical Center of New York.

Even though the expected benefit did not materialize, Adesman sees a reason to continue to study the medication. "There is [still] some suggestion of benefit from the medicine," Adesman said. "It just didn't quite show up where they expected."

The drug may offer benefit to some children with autism, Adesman said. "But it's unclear which children may be the best candidates."

The trial received funding from the drug's maker, Seaside Therapeutics. The medication is not currently approved by the U.S. Food and Drug Administration.

The data and conclusions of research presented at medical meetings should be viewed as preliminary until published in a peer-reviewed journal.

View the original article here

Gene-Based Blood Test for Colon Cancer Shows Promise

Early trial supports accuracy of the screening, which could be a boon in preventing the disease

By Robert Preidt

HealthDay Reporter

WEDNESDAY, June 19 (HealthDay News) -- Could screening for colon cancer someday be as easy as having a blood test? Researchers say just such a test is showing early promise in trials.

The screening checks for levels of miR-21 -- a piece of DNA known as microRNA. Researchers in the gastrointestinal cancer research lab at the Baylor Research Institute in Dallas studied several hundred patients with either colorectal polyps (noncancerous growths that often precede cancer) or full-blown cancer.

They found that measuring levels of miR-21 in the blood accurately spotted up to 92 percent of patients with colorectal cancer.

The test also accurately identified up to 82 percent of patients with advanced colorectal polyps -- growths that put people at high risk of developing colorectal cancer.

The study was published June 19 in the Journal of the National Cancer Institute.

"This blood-based test could be transformative in how we screen patients for colorectal cancer; it would save lives and could result in major savings of health care dollars," Dr. Michael Ramsay, president of Baylor Research Institute, said in an institute news release.

Other experts were cautiously optimistic.

"These results are very promising for the future of cancer screening and treatment," said Dr. Jerald Wishner, director of colorectal surgery at Northern Westchester Hospital in Mount Kisco, N.Y.

"Colonoscopy screening is the current gold standard to detect colon cancer. However, less than 50 percent of Americans who should be screened get screened," Wishner said. "The blood test is a less invasive screening method that will eliminate barriers to colonoscopies, including embarrassment and possible discomfort in preparation for the test."

Dr. David Robbins, associate chief of endoscopy at Lenox Hill Hospital in New York City, agreed that it is "only a matter of time before we can screen for the most common, and most lethal, cancers using a simple blood test."

"This well-designed study brings us one step closer to the holy grail of colon cancer eradication by identifying those at high risk for developing colon cancer by measuring a pretty straightforward genetic signature," Robbins said.

According to the American Cancer Society, colon cancer is the second leading cancer killer, after lung cancer. More than 102,000 new cases of the disease will be diagnosed among Americans this year, and almost 51,000 people will die from the disease in 2013.

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Treatment for New, Deadly Coronavirus Shows Promise

THURSDAY, April 18 (HealthDay News) -- A treatment for a new coronavirus that has caused 11 deaths, mostly in the Middle East, shows promise in early tests, U.S. government researchers report.

The investigators discovered that a combination of two antiviral drugs -- ribavirin and interferon-alpha 2b -- can stop the so-called nCoV coronavirus from multiplying in laboratory-grown cells. While the results suggest that this drug combination could be used to treat patients infected with nCoV, more research is needed to confirm these early findings.

Both drugs are approved in the United States for treating people with hepatitis C.

The nCoV coronavirus was first identified in Saudi Arabia in September 2012. As of April 16, 2013, there had been 17 reported cases, including 11 deaths. Most cases have occurred in the Middle East.

While the number of cases is small, there has been person-to-person transmission of the nCoV coronavirus in situations where people -- mainly family members -- have had close contact with infected people, the researchers noted in a news release from the U.S. National Institute of Allergy and Infectious Diseases (NIAID).

That, along with the high death rate, led the NIAID researchers to look for treatments. In laboratory tests using cells from two monkey species, the research team found that either ribavirin or interferon-alpha 2b alone could stop nCoV from replicating in the cells.

However, the drug concentrations needed to do this were higher than what is recommended for people. The researchers then combined the two drugs, and found that they were effective at a dose that can be used in people, according to the study in the April 18 issue of the journal Scientific Reports.

-- Robert Preidt
Copyright © 2013 HealthDay. All rights reserved. SOURCE: U.S. National Institute of Allergy and Infectious Diseases, news release, April 18, 2013

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New Kind of Therapy Shows Early Promise in MS Patients

Approach may shield patients' immune systems to allow safer treatment, study suggests

By Brenda Goodman

HealthDay Reporter

WEDNESDAY, June 5 (HealthDay News) -- A new therapy for multiple sclerosis that teaches the body to recognize and then ignore its own nerve tissue appears to be safe and well-tolerated in humans, a small new study shows.

If larger studies prove the technique can slow or stop the disease, the therapy would be a completely new way to treat autoimmune diseases such as multiple sclerosis (MS) and type 1 diabetes.

Most treatments for MS and other autoimmune diseases work by broadly suppressing immune function, leaving patients vulnerable to infections and cancers.

The new treatment targets only the proteins that come under attack when the immune system fails to recognize them as a normal part of the body. By creating tolerance to only a select few proteins, researchers hope they will be able to cure the disease but leave the rest of the body's defenses on guard.

"This is important work," said Dr. Lawrence Steinman, a professor of neurology at Stanford University who was not involved with the study.

"Very few investigators are trying therapies in humans aimed at simply turning off unwanted immune responses and leaving the rest of the immune system intact to fight infections -- to do surveillance against cancer," Steinman said. "The early results show encouragement."

For the study, published in the June 5 issue of the journal Science Translational Medicine, researchers in the United States and Germany recruited nine patients with MS. Seven had the relapsing-remitting form of the disease, while two others had secondary progressive MS (a more advanced phase). All were between the ages of 18 and 55, and were in good health except for their MS.

Blood tests conducted before the treatments showed that each patient had an immune reaction against at least one of seven myelin proteins.

Myelin is a white tissue made of fats and proteins that wraps nerve fibers, allowing them to conduct electrical signals through the body. In MS, the body attacks and gradually destroys these myelin sheaths. The damage disrupts nerve signals and leads to myriad symptoms, including numbness, tingling, weakness, loss of balance and disrupted muscle coordination.

Six patients in the study had low disease activity, while three others had a history of more active disease. Most were not experiencing symptoms at the time of their treatment.

On the day of the treatments, patients spent about two hours hooked up to a machine that filtered their blood, harvesting white cells while returning red cells and plasma to the body.

After the white cells were collected, they were washed and then combined with seven proteins that make up myelin tissue. A chemical was used to link the proteins to the white blood cells, which were dying.

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'Sensory-Focused' Autism Therapy Shows Early Promise

In small study, parents used variety of methods to stimulate boys' senses

By Mary Brophy Marcus

HealthDay Reporter

WEDNESDAY, June 5 (HealthDay News) -- Smelling essential oils, walking across textured surfaces, immersing hands in warm water -- these are just some of the therapeutic experiences that boys with autism had while participating in a small new study.

The scientists wanted to learn how "sensory-motor" therapy compared to traditional behavioral therapy methods in boys with autism.

Twenty-eight boys aged 3 to 12 and their parents participated in the six-month-long study, published online May 20 in Behavioral Neuroscience. The boys were split into two groups. Both groups of children participated in daily behavioral therapy, but 13 of the boys also received environmental enrichment, another term for sensory-motor therapy.

The environmental enrichment therapy had a significant positive effect on these children with autism, the study authors said.

"What we've done here for the first time is give humans a sensory-enriched environment and found out that a neurological disorder -- autism -- responds favorably. We saw a 600 percent greater likelihood of having a positive clinical outcome in individuals that had enriched environments compared to those receiving the standard care that children have been receiving for autism up to this point," said study author Michael Leon, a professor of neurobiology and behavior at Center for Autism Research and Treatment at the University of California, Irvine.

However, an autism expert who wasn't part of the study cautioned that other sensory-based therapies showing early promise haven't proven effective so far.

For the new study, parents of the children in the sensory enrichment group were given a kit that contained a broad range of materials aimed at stimulating their child's senses of smell, temperature, texture, sight and movement. Vials of essential oils scented of apple, lavender, sweet orange and vanilla, were among the items. Squares of different textured materials included smooth foam, hardwood flooring, sponges, felt and sandpaper.

The children were also given the opportunity to play with objects: beads, a small piggy bank with plastic coins, pictures of famous art, a can of Play-Doh, a bowl to hold warm or cool water and more.

The researchers asked parents to conduct two therapy sessions a day with their child, and to run four to seven different exercises during each session that involved different combinations of the items in the kit. Sessions ranged from 15 to 30 minutes. The children also listened to classical music once a day.

As the six-month period progressed, parents were encouraged to offer more complex enrichment exercises. For example, a child would be given the chance to select a textured square and in addition to feeling it would be encouraged to match it to another square of the same material.

By the end of the six months, Leon said the enrichment group children had significantly improved compared to the children who received standard therapy alone. He said 42 percent of the boys in the enrichment group improved in their ability to relate to other people and in their ability to respond to sights and sounds, compared with 7 percent of the standard care group.

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Autism, ADHD Often Occur Together, Research Shows

Study finds nearly one-third of kids with autism also have problems with attention and hyperactivity

By Brenda Goodman

HealthDay Reporter

THURSDAY, June 6 (HealthDay News) -- Almost 30 percent of young children with autism also show signs of attention-deficit/hyperactivity disorder (ADHD), a rate that's three times higher than it is in the general population, a new study shows.

"We don't know the cause for ADHD in most cases. We don't know the cause of autism in most cases. It's not surprising that something that's going to affect the brain and cause one developmental outcome may also cause a second developmental outcome," said Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at Steven and Alexandra Cohen Children's Medical Center in Lake Success, N.Y. He was not involved in the study.

Kids in the study who had both problems together also tended to have more difficulty learning and socializing than children who had autism alone.

The researchers noted that the treatment of ADHD may benefit children with autism if they aren't making progress with autism treatment programs, which often require sustained focus on specific skills.

"In a child [with autism] who has great difficulties with attention, or hyperactivity or both, you really have to layer in another level of intervention strategies for them," said study author Rebecca Landa, director of the Center for Autism and Related Disorders at the Kennedy Krieger Institute in Baltimore.

For the study, which is published in the June 5 online issue of the journal Autism, researchers asked parents of kids enrolled in a community-based study of child development about symptoms of attention and hyperactivity -- whether or not children could wait their turn, interrupted others who were speaking, fiddled with things during meals or could not slow down, for example. All the children in the study were between the ages of 4 and 8.

Out of 62 children diagnosed with autism, 18 (29 percent) also showed signs of ADHD.

A previous study of slightly older children found that 31 percent of children had the two disorders together.

"It's not surprising," said Dr. Patty Manning-Courtney, director of the Kelly O'Leary Center for Autism Spectrum Disorders at Cincinnati Children's Hospital Medical Center.

"What's good about this study is that they went to the trouble to look at who met diagnostic criteria and what was different about those children," said Manning-Courtney, who was not involved in the research.

All the children who had both problems together were boys. Boys have higher rates of autism and ADHD than girls, research shows.

One limitation of the study was that researchers had to rely on questionnaires that are meant to spot ADHD in typical children. There really aren't good tests for attention and hyperactivity developed for kids with autism, and their problems may look different than those seen in typical school-aged children.

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More Evidence Shows Hormone Therapy May Increase Breast Cancer Risk

In new analysis, researchers found risk highest when used just before menopause

By Kathleen Doheny

HealthDay Reporter

FRIDAY, March 29 (HealthDay News) -- Women who take hormone therapy that includes estrogen and progestin are at increased risk of developing breast cancer and dying from it, especially if they start taking the therapy just as menopause begins, a new analysis confirms.

Researchers followed nearly 42,000 women, all of whom were past menopause, for an average of more than 11 years. Of those, more than 25,000 did not use hormone therapy and more than 16,000 took estrogen and progestin, also called combined hormone therapy. For this analysis, the researchers did not include estrogen-only therapy, used by women who have had a hysterectomy.

At the end of the follow-up period, more than 2,200 of the women were found to have breast cancer. Compared to non-users, those who took combined therapy were more likely to have breast cancer, said Dr. Rowan Chlebowski, a medical oncologist at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. Chlebowski led the study, which was published in the March 29 issue of the Journal of the National Cancer Institute.

The link has been found in other studies, but Chlebowski also found the risk was greatest among those who took the hormones closest to menopause. "Women starting within months of menopause had about a threefold greater risk than women starting 10 years after menopause," Chlebowski said.

For the new analysis, Chlebowksi looked at results from the Women's Health Initiative observational study. He compared the findings with those from the Women's Health Initiative randomized clinical trial, in which women were assigned to different treatments.

The Women's Health Initiative included four clinical trials and an observational study. Women were all past menopause and were aged 50 to 79.

Chlebowski said he did the new analysis to resolve what he saw as unanswered questions. In the trial, only about one-third, or 5,000, of the women were in their 50s when they started the study. As that is the typical age for menopause to start, about two-thirds of the women in the trial were in their 60s or beyond, so began to take hormones several years after menopause.

Chlebowski set out to see if the link between breast cancer risk and combined hormone therapy use was influenced by earlier use of hormones.

"We had a substantial number closer to menopause than the clinical trial of [the Women's Health Initiative]," he said.

He found, however, that not only was the risk of breast cancer still increased, but it also increased even more if the women were closer to menopause when they began to take the hormones.

He speculated that women who start the hormone therapy close to menopause still have circulating levels of estrogen high enough to make them exceed some threshold, beyond which it may become hazardous.

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Drug Shows Promise Against Advanced Melanoma

In preliminary trial, nivolumab shrank tumors in 30 percent of tough-to-treat patients

By Alan Mozes

HealthDay Reporter

SATURDAY, June 1 (HealthDay News) -- Nearly one-third of patients with advanced melanomas who received nivolumab, a new immune-based drug, experienced reductions in the size of their tumors, a preliminary study reveals.

Since these types of drugs have typically shrunk tumors in only 5 percent to 10 percent of patients in prior studies, the new results are a boost for immunotherapy generally, the researchers noted.

"I think nivolumab is a real breakthrough drug for patients with metastatic melanoma, and probably for other diseases, too," study author Dr. Mario Sznol, a professor of medical oncology at the Yale Cancer Center in New Haven, Conn., said in a news release.

"The high level of activity observed with this drug opens up a number of avenues for future research to understand and challenge the ways tumors evade the immune system. We're very excited that there is potential for even more activity in combination with other drugs," Sznol added.

One expert not connected to the study was also optimistic about the results.

"Nivolumab shows exciting promise for patients suffering from an otherwise fatal disease -- metastatic melanoma," said Dr. Michele Green, a dermatologist at Lenox Hill Hospital in New York City. "The fact that 30 percent of patients showed improvement from this immunotherapy drug is remarkable since these patients had some of the worse disease."

The study was funded by drugmaker Bristol-Myers Squibb and is scheduled for presentation Saturday at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Findings presented at medical meetings are typically considered preliminary until published in a peer-reviewed journal.

According to the researchers, nivolumab works by honing in on PD-1 cellular receptors located on immune system T-cells. These receptors are known to function as immune system "gatekeepers," and by working to open such gates the patient's immune system is triggered into cancer-fighting action.

The new study involved 107 patients, all of whom had been previously treated with multiple forms of standard therapies that failed to halt their disease.

Following treatment with one of five different doses of nivolumab, the team found that 31 percent of the patients went on to experience a minimum tumor shrinkage of 30 percent across the various doses.

Forty-three percent of the patients are estimated to have survived two years after treatment, the researchers said, and average survival for patients across all treatment doses is now projected to be nearly 17 months.

In an ASCO news release, melanoma expert Dr. Lynn Schuchter called the results "truly remarkable."

The findings "confirm that 'revving' up the immune system is a powerful approach in shrinking melanoma," said Schuchter, who is also a spokeswoman for ASCO. "Melanoma patients are living longer and better with these new treatments."

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Immune Therapy Shows Early Promise for Advanced Leukemia

Title: Immune Therapy Shows Early Promise for Advanced Leukemia
Category: Health News
Created: 3/20/2013 4:35:00 PM
Last Editorial Review: 3/21/2013 12:00:00 AM

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DNA Test Shows Promise in Guiding Advanced Breast Cancer Care

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New public database shows hospital billing charges all over the map

Posted May 10, 2013, 8:27 am

Most reputable companies that provide services tell you what you’ll get for your money. Hospitals are an exception. They haven’t traditionally made public the cost of operations and other procedures. This secrecy has let hospitals set widely different prices for the same procedure. It’s also made it impossible to do any comparison shopping.

Yesterday’s release to the public of a once very private database shows just how big the differences can be from hospital to hospital.

On the South Side of Chicago, where I grew up, one hospital’s charge for implanting a pacemaker to keep the heart beating at a steady rhythm was $49,601, while another hospital charged $63,979 to do it. In Boston, a hospital not far from where I work charged $76,121 to implant a pacemaker while another hospital less than three miles away charged $55,687.

According to The New York Times, the Keck Hospital of the University of Southern California charged an average of $123,885 for a major artificial joint replacement (six times the average amount that Medicare reimbursed for the procedure) while Centinela Hospital Medical Center, also in Los Angeles, charged $220,881 for the same type of joint replacement surgery.

The database, released by the Centers for Medicare and Medicaid Services, details what 3,300 hospitals charged for the 100 most common treatments and procedures in 2011.

The data reinforce the big differences in charges from one part of the U.S. to another. What’s new and surprising are the huge differences sometimes seen between hospitals in the same city, or even the same neighborhood.

Keep in mind that these “charges” aren’t hard and fast. Medicare doesn’t pay the full charge. Insurers don’t either, as many of them negotiate lower charges. As NPR’s Robert Siegel said about the database, “it sounds like what you’ve got is a survey of the sticker prices in car lots all around America, but every deal is a special deal.”

At least for now, the database isn’t especially easy to use. It’s just an Excel spreadsheet listing the hospitals by state along their charges for the 100 procedures. The Washington Post created a nifty interactive tool that you can use to look at charges in your state for 10 conditions. Choose your state and the tool shows how its hospitals stack up against the national average, as well as the highest and lowest charges for these ten procedures. Expect other creative apps incorporating this information to be coming along soon.

If you decide to dive into the data, be aware—especially if you have private insurance (not Medicare)—that appearances can be deceiving. It may look like Hospital A charges more than Hospital B, but that may not be so. Your insurer and Hospital may have actually agreed on a lower payment. So the data don’t necessarily say what your insurance company is actually going to pay.

A few weeks ago, I finally finished reading “Bitter Pill,” Steven Brill’s extraordinary Time magazine article on the crazy cost of healthcare in America. I say “crazy” because, according to Brill, how hospitals set their prices has little rhyme or reason. The database from the Centers for Medicare and Medicaid Services reinforces that notion.

Publishing this information is one small step toward making the cost of healthcare more transparent. While it will be a long time before most of us will be able to figure out how much an operation or a hospital stay costs, the database could nudge hospitals with exorbitant charges to bring them in line.

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Gene Therapy Shows Early Promise for Heart Failure

By Amy Norton

HealthDay Reporter

THURSDAY, Feb. 21 (HealthDay News) -- When it comes to treating heart failure, the ultimate hope is to develop a therapy that repairs the damaged heart muscle.

Now, an early study hints at a way to do that by harnessing the body's natural capacity for repair.

Heart failure is a chronic, progressive condition where the heart cannot pump blood efficiently enough to meet the body's needs, which leads to problems like fatigue, breathlessness and swelling in the legs and feet. Most often, it arises after a heart attack leaves heart muscle damaged and scarred.

In the new study, researchers were able to use gene therapy to modestly improve symptoms in 17 patients with stage III heart failure -- where the disease is advanced enough that even routine daily tasks become difficult.

What is novel about the tactic, the researchers said, is that the gene therapy is designed to attract the body's own stem cells to the part of the heart muscle that's damaged. The hope is that the stem cells will then get some repair work done.

The findings, published Feb. 21 in the journal Circulation Research, are preliminary, and much more research needs to be done.

"This is a proof-of-concept study," explained lead researcher Dr. Marc Penn, a professor at Northeast Ohio Medical University in Rootstown, and director of research at Summa Cardiovascular Institute in Akron. But Penn and other heart failure experts said they were cautiously optimistic about the therapy's potential for at least some patients.

Stem cells are primitive cells that can develop into different types of body tissue. Adults have the cells in their bone marrow, and they give rise to blood cells. Researchers have also found that individual organs in the body, including the heart, have their own pools of stem cells.

Those stem cells may try to repair damaged tissue, but they are not all that successful, Penn said. So his team sought to give the stem cells a helping hand. They infused patients' heart muscle with three different doses of a drug that carried a gene for SDF-1, a natural protein in the body believed to recruit stem cells to sites of tissue damage.

Lab research has suggested that after a heart attack, SDF-1 activity in the heart goes up -- but only for a short time, Penn said. The goal of the experimental therapy is to enhance SDF-1 and draw more stem cells to where they are needed.

The initial results are promising, Penn said. The approach seemed safe, with no major side effects linked to the treatment. Two of the study patients died within a year, but the deaths were deemed not to be connected to the treatment.

Among the 15 patients who were alive one year later, there were improvements in their symptoms and walking ability.

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Surgical Delivery of Drug Shows Promise Against 'Bleeding' Stroke

Title: Surgical Delivery of Drug Shows Promise Against 'Bleeding' Stroke
Category: Health News
Created: 2/7/2013 2:36:00 PM
Last Editorial Review: 2/8/2013 12:00:00 AM

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Drug Shows Promise for Lupus Skin Conditions

BySalynn Boyles
WebMD Health News Reviewed byLouise Chang, MD

Dec. 7, 2012 -- A drug related to thalidomide may be more potent and less toxic than thalidomide, which is often used to treat lupus skin conditions.

In a small study from Spain, lupus patients showed dramatic improvements in skin lesions while taking the drug, lenalidomide (Revlimid), and most relapsed soon after they stopped taking it.

Thalidomide’s Infamous Past

Thalidomide is best known as the drug that caused thousands of children to be born with missing limbs and other birth defects in the late 1950s and early 1960s.

In more recent years it has been brought back to the market to treat a number of serious conditions, but its use is monitored closely to ensure that it is not taken by women who are pregnant or who might become pregnant.

Dermatology professor Andrew G. Franks Jr., MD, of the NYU Langone Medical Center, says thalidomide is very effective for treating people with lupus skin conditions who do not respond to standard treatments such as steroids and antimalarial drugs.

He says about 75% of patients with affected skin will go into remission with these standard treatments.

“The question has been, ‘What do you do with the rest?’” he says.

Franks says thalidomide can help an additional 75% of patients achieve remission. But side effects are common and some, including nerve damage in the hands and feet, can be permanent.

Lenalidomide Highly Effective in Small Study

The lenalidomide study included 15 women with lupus skin conditions; six had lupus in other areas of the body, too. They all were followed for seven to 30 months.

All had received standard treatments, and 14 had been treated with thalidomide previously.

The majority of the patients (60%) had the most common subtype of lupus-related skin disease, known as discoid lupus erythematosus, which is characterized by red, scaly patches that can scar.

One patient withdrew from the study after one week due to digestive system side effects. All the other patients showed improvement, and the rash cleared up in 86%.

The researchers note that the study dose was “generally well-tolerated.” No new nerve symptoms were reported.

Similar to treatment with thalidomide, most of the patients had a relapse of their skin problems within weeks of stopping the drug.

No Progression to Full Disease

Several earlier small studies raised concerns that treatment with lenalidomide may be linked to an increased risk of progression to full-blown lupus, not just lupus limited to the skin.

Josep Ordi-Ros, who led the Spanish study, says this was not seen in the latest study, which was published Dec. 6 in the journal Arthritis Research & Therapy.

But Cynthia Aranow, MD, of the Feinstein Institute for Medical Research in Manhasset, N.Y., says larger studies will be needed to determine if the drug is truly safe and effective for patients who do not respond to other treatments.

She adds that the drug appears to have a similar risk for birth defects as thalidomide, so it will need to be monitored just as carefully.

“There are many questions that remain,” she says.

Lenalidomide is available as Revlimid to treat people with multiple myeloma and myelodysplastic syndromes. According to the manufacturer’s site, the cost of Revlimid at the doses used in this study would be about $440 a pill.

View Article Sources

SOURCES:

Cortes-Hernandez, J. Arthritis Research & Therapy, Dec. 6, 2012.

Andrew G. Franks, Jr., MD, director, Skin, Lupus & Autoimmune Connective Tissue Disease Center; clinical professor of dermatology and medicine (rhematology), NYU Langone Medical Center, New York.

Cynthia Aranow, MD, researcher, Feinstein Institute for Medical Research, Manhasset, N.Y.

News release, BioMed Central.

Revlimid web site: "Information for Prescribers of Prescription Drugs."

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