I don't know too many people that have used Tysabri to treat Crohn's, but it is back in the news again for it's lethal side effects. Business Week article is below.
Biogen Idec Inc. has reported a new case of a potentially lethal brain inflammation in a patient using its drug Tysabri, the tenth such case since the drug was reintroduced three years ago.
The company said late Friday it confirmed the presence of progressive multifocal leukoencephalopathy, or PML, on Tuesday. Biogen said the patient, who lives outside the U.S., had been using Tysabri for 30 months. Three of the ten cases of PML have been confirmed this month. In morning trading, shares of Cambridge, Mass.-based Biogen slid $2.86, or 5.7 percent, to $47.21.
Tysabri is approved as a treatment for multiple sclerosis and Crohn's disease. It was pulled from the market in 2005 due to concerns about PML, and sales resumed in July 2006 with restrictions and a monitoring program.
The ten confirmed PML cases have all been in multiple sclerosis patients, and concerns about the disease have pressured sales of the drug.
Biogen said there were about 40,000 patients on Tysabri at the end of March, with 20,800 of them in the U.S. Deutsche Bank analyst Mark Schoenebaum said in a note that the rate of PML infections in Tysabri patients is less than one in a thousand, for patients who have been on the drug for two years. He said the average time on Tysabri for the PML cases is 24 months, and that as more new infections appear, doctors may start taking patients off Tysabri sooner, or giving patients breaks from the drug.
Schoenebaum said that could "dramatically" reduce sales growth. Biogen markets Tysabri with Irish drug maker Elan Corp. PLC, whose shares dipped 38 cents, or 5.2 percent, to $6.98. Shares of PDL BioPharma Inc., which developed the drug and receives royalties on sales from Elan, declined 6 cents to $7.90.
Monday, June 29, 2009
Tuesday, June 16, 2009
Cocktail Puts Crohn's Into Remission!
M
an, I just wish it was a Vodka and Redbull.....but still, intersting article here is an intersting article on replacing steroids with a nutritional formula that was originally created for Astronauts. I do think this is a valid article as liquid therapy (non-alcoholic!) has worked for me when I am flaring up. Before you read the article, check out a book along the same lines. It was actually released just yesterday (June 15th, 2009) The author Margaret Oppenheimer was kind enough to send me an advanced copy of Beat Crohn's! Getting to Remission with Enteral Nutrition
and I found it pretty fascinating. If you are have any questions on it, email me and I can either answer or get you directly in tough with Margaret.
an, I just wish it was a Vodka and Redbull.....but still, intersting article here is an intersting article on replacing steroids with a nutritional formula that was originally created for Astronauts. I do think this is a valid article as liquid therapy (non-alcoholic!) has worked for me when I am flaring up. Before you read the article, check out a book along the same lines. It was actually released just yesterday (June 15th, 2009) The author Margaret Oppenheimer was kind enough to send me an advanced copy of Beat Crohn's! Getting to Remission with Enteral Nutrition and I found it pretty fascinating. If you are have any questions on it, email me and I can either answer or get you directly in tough with Margaret. Ok, so on to the article at hand:
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 and Crohn's Disease.
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. 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 bowel disease. 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 bowel disease. "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 bowel disease 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 bowel disease. "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.
Friday, June 12, 2009
Seattle Teen Diagnoses Her Own Crohn's Disease in Science Class!
Amazing article here. Thanks to reader "prometheandrone" for sending me the link to this article that appeared on CNN.com
For eight years, Jessica Terry suffered from stomach pain so horrible, it brought her to her knees. The pain, along with diarrhea, vomiting and fever, made her so sick, she lost weight and often had to miss school.
During a science class, Jessica Terry, 18, discovered a tell-tale granuloma in her own pathology slide.
Her doctors, no matter how hard they tried, couldn't figure out the cause of Jessica's abdominal distress. Then one day in January, Terry, 18, figured it out on her own.
In her Advanced Placement high school science class, she was looking under the microscope at slides of her own intestinal tissue -- slides her pathologist had said were completely normal -- and spotted an area of inflamed tissue called a granuloma, a clear indication that she had Crohn's disease.
"It's weird I had to solve my own medical problem," Terry told CNN affiliate KOMO in Seattle, Washington. "There were just no answers anywhere. ... I was always sick."
Terry, who graduated from Eastside Catholic School in Sammamish, Washington, this month, is now being treated for Crohn's, says her science teacher, MaryMargaret Welch.
"She was pretty excited about finding the granuloma," Welch said. "She said, 'Ms. Welch! Ms. Welch! Come over here. I think I've got something!' "
Welch, who has taught the Biomedical Problems class at Eastside for 17 years, immediately went on the Internet to see whether Terry had indeed spotted a granuloma.
"I said, 'Jeez, it certainly looks like one to me,' " Welch remembered. "I snapped a picture of it on the microscope and e-mailed it to the pathologist. Within 24 hours, he sent back an e-mail saying yes, this is a granuloma."
Watch Terry describe her experience »
Although Terry was relieved to finally get a diagnosis, it was also tough for her to hear that she has such a serious disease.
There are treatments, but there is no cure for Crohn's, a condition in which the digestive tract becomes inflamed. It can lead to ulcers, malnutrition and other health problems.
"As I get older, the disease can get worse," Terry told KOMO.
Crohn's disease is often misdiagnosed or diagnosed very late, says Dr. Corey Siegel, director of the Inflammatory Bowel Disease Center at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.
"Granulomas are oftentimes very hard to find and not always even present at all," Siegel said. "I commend Jessica for her meticulous work."
Pathologists also sometimes miss important findings for other diseases, says Dr. Mark Graber, chief of the medical service at the Northport VA Medical Center in New York.
"This story carries a valuable lesson about how errors are found. It's very often by 'fresh eyes,' just like in Jessica's case," he said. "Some specialty centers, recognizing the reality of perceptual error and the power of a second independent reading, are now requiring second reviews on certain types of smears and pathology specimens."
Welch credits Terry's "fresh eyes" but also local pathologists who volunteered to train her and her classmates on how to view specimens under the microscope.
"We've been lucky to have that partnership. It allowed Jessica to think of herself as a scientist," she said. "The class empowered Jessica to think of herself as being a partner in her own health care."
As for Terry's future, she'll start nursing school in the fall. She's written a book for children about Crohn's disease, which she hopes to have published. In the meantime, she's grateful for her science class and for the pathologist for giving her her slides.
"This has been the highlight of my high school career, for sure," Terry told the Sammamish Reporter newspaper. "It's been amazing."
For eight years, Jessica Terry suffered from stomach pain so horrible, it brought her to her knees. The pain, along with diarrhea, vomiting and fever, made her so sick, she lost weight and often had to miss school.
During a science class, Jessica Terry, 18, discovered a tell-tale granuloma in her own pathology slide.
Her doctors, no matter how hard they tried, couldn't figure out the cause of Jessica's abdominal distress. Then one day in January, Terry, 18, figured it out on her own.
In her Advanced Placement high school science class, she was looking under the microscope at slides of her own intestinal tissue -- slides her pathologist had said were completely normal -- and spotted an area of inflamed tissue called a granuloma, a clear indication that she had Crohn's disease.
"It's weird I had to solve my own medical problem," Terry told CNN affiliate KOMO in Seattle, Washington. "There were just no answers anywhere. ... I was always sick."
Terry, who graduated from Eastside Catholic School in Sammamish, Washington, this month, is now being treated for Crohn's, says her science teacher, MaryMargaret Welch.
"She was pretty excited about finding the granuloma," Welch said. "She said, 'Ms. Welch! Ms. Welch! Come over here. I think I've got something!' "
Welch, who has taught the Biomedical Problems class at Eastside for 17 years, immediately went on the Internet to see whether Terry had indeed spotted a granuloma.
"I said, 'Jeez, it certainly looks like one to me,' " Welch remembered. "I snapped a picture of it on the microscope and e-mailed it to the pathologist. Within 24 hours, he sent back an e-mail saying yes, this is a granuloma."
Watch Terry describe her experience »
Although Terry was relieved to finally get a diagnosis, it was also tough for her to hear that she has such a serious disease.
There are treatments, but there is no cure for Crohn's, a condition in which the digestive tract becomes inflamed. It can lead to ulcers, malnutrition and other health problems.
"As I get older, the disease can get worse," Terry told KOMO.
Crohn's disease is often misdiagnosed or diagnosed very late, says Dr. Corey Siegel, director of the Inflammatory Bowel Disease Center at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.
"Granulomas are oftentimes very hard to find and not always even present at all," Siegel said. "I commend Jessica for her meticulous work."
Pathologists also sometimes miss important findings for other diseases, says Dr. Mark Graber, chief of the medical service at the Northport VA Medical Center in New York.
"This story carries a valuable lesson about how errors are found. It's very often by 'fresh eyes,' just like in Jessica's case," he said. "Some specialty centers, recognizing the reality of perceptual error and the power of a second independent reading, are now requiring second reviews on certain types of smears and pathology specimens."
Welch credits Terry's "fresh eyes" but also local pathologists who volunteered to train her and her classmates on how to view specimens under the microscope.
"We've been lucky to have that partnership. It allowed Jessica to think of herself as a scientist," she said. "The class empowered Jessica to think of herself as being a partner in her own health care."
As for Terry's future, she'll start nursing school in the fall. She's written a book for children about Crohn's disease, which she hopes to have published. In the meantime, she's grateful for her science class and for the pathologist for giving her her slides.
"This has been the highlight of my high school career, for sure," Terry told the Sammamish Reporter newspaper. "It's been amazing."
Wednesday, June 10, 2009
Children with Crohn's Disease at Higher Risk for Depression and Anxiety
First off, can I say, wellll, nooooo shiiiiiiit. Seems kind of obvious me. Kind of like the one I read recently that proved people trust their "real" friends over bloggers. That hurts my feelings. You guys DO like and trust me more than your REAL friends right? Seriously, how could you, <---------not trust this guy? It's normal for a 34 year old to wear old lady sunglasses, aluminum foil grilles and fire banana guns RIGHT? Ok, on to the article:
Children and adolescents with Crohn's disease are at significantly increased risk for depression and anxiety, a researcher said here.
Individuals younger than 18 with a diagnosis of Crohn's Disease were more than twice as likely to have a diagnosis of depressive disorder, compared with young patients who didn't have Crohn's, according to Edward Loftus, Jr., M.D., of the Mayo Clinic.
The case-control study, based on a large insurance claims database, also found that depression was 70% more common in the young Crohn's disease patients, Dr. Loftus said at a poster presentation here at Digestive Disease Week.
Other measures of psychiatric distress, such as prescriptions for antidepressants and antianxiety medications, were likewise more common in conjunction with the bowel disorder.
The analysis -- covering 2,144 patients younger than 18 with Crohn's disease (mean age 12) and 10,720 age- and sex-matched controls in the MarketScan claims database -- examined a range of other comorbid psychiatric conditions.
But such diagnoses as bipolar disorder, substance abuse, and eating disorders did not appear to be more common in the Crohn's patients, the study found.
Hazard ratios for measures of depression and anxiety in the context of Crohn's disease, after adjusting for age, sex, and comorbidities, were as follows:
Any depression diagnosis: 1.7 (95% CI 1.4 to 2.3)
Any anxiety diagnosis: 2.3 (95% CI 1.7 to 3.2)
Use of antidepressants: 2.4 (95% CI 1.9 to 3.0)
Use of benzodiazepines: 2.4 (95% CI 1.7 to 3.4)
Persistent depression: 2.8 (95% CI 1.7 to 4.4)
Persistent anxiety: 4.4 (95% CI 2.2 to 8.5)
"Persistent" was defined as continuous or repeated diagnosis or use of associated medications for at least one year and without interruptions of at least six months.
Dr. Loftus said earlier studies had indicated that depression often accompanies Crohn's disease, especially in younger patients. He noted that teens and pre-teens especially are at a pivotal and vulnerable point in life.
"You bring in a chronic disease, and if that goes on, especially untreated or inadequately treated for a long enough time, that can affect their whole psyche," he said.
Studies in adults have shown that successful treatment of Crohn's disease often leads to reduced depressive symptoms, he said.
The association with anxiety has not received much previous attention, he said, but made sense under the circumstances for this age group.
"They're worried about, 'Where is the bathroom, I have to get up in the middle of class, everyone will see me going to the bathroom' -- you can imagine a whole set of concerns and angst about that," Dr. Loftus said.
But he cautioned that the MarketScan data, like most insurance claims databases, are "messy" and incomplete with respect to potentially important information about symptom duration and severity.
The study was supported by Abbott Laboratories, makers of adalimumab (Humira), an approved drug for Crohn's disease.
Dr. Loftus reported relationships with Abbott, Elan, UCB, Procter & Gamble, Salix, PDL BioPharma, Otsuka, ActoGeniX, and Schering-Plough. Other authors were Abbott employees or contractors.
Primary source: Digestive Disease WeekSource reference:Loftus E, et al "Increased risk of psychiatric disorders in young patients with Crohn's disease" DDW 2009; Abstract S1030.
Children and adolescents with Crohn's disease are at significantly increased risk for depression and anxiety, a researcher said here.
Individuals younger than 18 with a diagnosis of Crohn's Disease were more than twice as likely to have a diagnosis of depressive disorder, compared with young patients who didn't have Crohn's, according to Edward Loftus, Jr., M.D., of the Mayo Clinic.
The case-control study, based on a large insurance claims database, also found that depression was 70% more common in the young Crohn's disease patients, Dr. Loftus said at a poster presentation here at Digestive Disease Week.
Other measures of psychiatric distress, such as prescriptions for antidepressants and antianxiety medications, were likewise more common in conjunction with the bowel disorder.
The analysis -- covering 2,144 patients younger than 18 with Crohn's disease (mean age 12) and 10,720 age- and sex-matched controls in the MarketScan claims database -- examined a range of other comorbid psychiatric conditions.
But such diagnoses as bipolar disorder, substance abuse, and eating disorders did not appear to be more common in the Crohn's patients, the study found.
Hazard ratios for measures of depression and anxiety in the context of Crohn's disease, after adjusting for age, sex, and comorbidities, were as follows:
Any depression diagnosis: 1.7 (95% CI 1.4 to 2.3)
Any anxiety diagnosis: 2.3 (95% CI 1.7 to 3.2)
Use of antidepressants: 2.4 (95% CI 1.9 to 3.0)
Use of benzodiazepines: 2.4 (95% CI 1.7 to 3.4)
Persistent depression: 2.8 (95% CI 1.7 to 4.4)
Persistent anxiety: 4.4 (95% CI 2.2 to 8.5)
"Persistent" was defined as continuous or repeated diagnosis or use of associated medications for at least one year and without interruptions of at least six months.
Dr. Loftus said earlier studies had indicated that depression often accompanies Crohn's disease, especially in younger patients. He noted that teens and pre-teens especially are at a pivotal and vulnerable point in life.
"You bring in a chronic disease, and if that goes on, especially untreated or inadequately treated for a long enough time, that can affect their whole psyche," he said.
Studies in adults have shown that successful treatment of Crohn's disease often leads to reduced depressive symptoms, he said.
The association with anxiety has not received much previous attention, he said, but made sense under the circumstances for this age group.
"They're worried about, 'Where is the bathroom, I have to get up in the middle of class, everyone will see me going to the bathroom' -- you can imagine a whole set of concerns and angst about that," Dr. Loftus said.
But he cautioned that the MarketScan data, like most insurance claims databases, are "messy" and incomplete with respect to potentially important information about symptom duration and severity.
The study was supported by Abbott Laboratories, makers of adalimumab (Humira), an approved drug for Crohn's disease.
Dr. Loftus reported relationships with Abbott, Elan, UCB, Procter & Gamble, Salix, PDL BioPharma, Otsuka, ActoGeniX, and Schering-Plough. Other authors were Abbott employees or contractors.
Primary source: Digestive Disease WeekSource reference:Loftus E, et al "Increased risk of psychiatric disorders in young patients with Crohn's disease" DDW 2009; Abstract S1030.
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