A new drug has been approved to help sufferers of Crohn’s disease, the U.S. Food and Drug Administration announced today. Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn’s disease who have not responded to conventional therapies. This product was approved with a Medication Guide.

Crohn’s disease is a chronic, inflammatory bowel disease that affects more than 1 million men and women worldwide. It has no cure and its cause is unknown. Crohn’s can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs.

“Crohn’s is a debilitating disease that disrupts the quality of life for its sufferers,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA’s Center for Drug Evaluation and Research. “This drug works to reduce the signs and symptoms of Crohn’s, but it also carries risks that will require patients on it to be closely monitored by their physicians or other health care professionals.”

Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.

The most common side effects of Cimzia are headache, upper respiratory infections, abdominal pain, injection site reactions and nausea.

Patients taking Cimzia are at increased risk for serious adverse effects, including serious infections that can lead to hospitalization or death. Because Cimzia affects the immune system, it can lower the body’s ability to fight infections, such as tuberculosis and other opportunistic infections. Cimzia is a blocker of TNF (tumor necrosis factor) and may cause lymphomas (a form of cancer) and other malignancies. Although an increased risk of tumors was not seen in studies of Cimzia, the modest size and relatively short duration of the controlled studies prevents any firm conclusion. Post-marketing studies and clinical trials will be required to obtain long-term safety data.

Patients taking Cimzia should be educated about how to identify an infection and be instructed to contact their health care professional at the first sign of infection while on Cimzia. In cases of serious infections, the drug should be discontinued immediately.

Cimzia is manufactured by UCB, Inc., Smyrna, GA.

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Dear Friends-

To mark the one year anniversary of my surgery, Kate and I will once again be walking with the Crohn’s & Colitis Foundation of America to raise money and awareness for Crohn’s Disease. CCFA is such an important organization to the millions of people fighting IB Diseases, like me. We are thrilled that I have come full circle from last year, and we hope you will join us in supporting the CCFA to keep me on the path to a cure.

We will be walking by the beach in Belmar, NJ this year on June 1^st and hope to raise $1000. Please click here to make a donation on our webpage. Thanks so much for your support!

Dave & Kate  

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NESS CITY, Kansas (AP) — A man whose girlfriend authorities say spent nearly two years in a bathroom in their house, sitting on the toilet so long that the seat adhered to her body, has been charged with mistreatment of a dependent adult.
Kory McFarren, 37, was charged Monday in Ness County District Court.

McFarren called the Ness County Sheriff’s Office in late February to say something was wrong with his girlfriend. When authorities arrived at the home, they found Pam Babcock, 35, stuck to the toilet, which they think she had sat on for about a month.

McFarren told authorities that Babcock feared leaving the bathroom and may not have left it in two years, although said he was unsure how long she was in there. He said that he took her food and water daily, and that he repeatedly asked her to come out but that she usually replied “maybe tomorrow.”

“The only thing I am guilty of is I didn’t get her help sooner,” McFarren told The Associated Press nearly a week ago.

Ness County Attorney Craig Crosswhite said the mistreatment charge most closely fit the situation.

“I looked at the statutes and spoke to the attorney general’s office,” he said. “This was a very unusual set of circumstances, and this is the law that most closely applied to the situation.”

Authorities said Babcock sat on the toilet so long that open sores developed and caused her to become attached to the seat. Sheriff Bryan Whipple has said that he used a pry bar to remove the seat from the toilet, and that the woman was taken to the hospital with the seat still attached.

“She would have to be sleeping on the toilet,” Whipple said.

Doctors at a Wichita, Kansas, hospital where Babcock was taken told McFarren that an infection in her legs had damaged her nerves and could leave her in a wheelchair. She was still at the hospital Wednesday night.

McFarren’s first court appearance will be in April, Crosswhite said

I just can’t even comprehend how this could ever seem right in anybodies head. If Kate refused to leave the bathroom after an hour I’d be on the phone with 911. There is no reason anybody should want to spend any amount of time on the toilet; let alone saying they’d get off it, “Maybe tomorrow.” Beyond Pam needing serious mental help, Kory in my books has just won the dumbest man alive award.

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For a competitor who loves the long races, Kalyn Keller is in for what will likely be the most challenging race of her life. Keller, a 2004 Olympian and former NCAA champion, is reportedly retiring from the sport after recently being diagnosed with Crohn’s disease.

Keller says she plans to move home to Arizona with her parents, leaving Club Wolverine where she’s trained since January. Keller, who’d competed along with her brother Klete at the 2004 Olympic Games, had recently made the transition to Open Water Swimming. She won the USA’s first ever Open Water Swimming medal at the 2007 Fina World Championships, taking home a silver in the women’s 25k.

According to a report in the Detroit Free Press (read the full article here), Keller says she started feeling sick in mid-July after a fourth place finish in the women’s 10k open water race at Pan-Ams in Brazil. After finishing fourth at the U.S. open-water 10k trials in Florida this past October, Keller was no longer in the running to qualify for Beijing in 2008.

Keller tells the Detroit Free Press that she’s got to go home now and “do what I have to do to get healthy.” For a swimmer who’s taken to the most gruelling of races, she is likely in for a gruelling struggle.

Crohn’s disease is essentially a type of bowel disease where the lining of the digestive tract becomes inflamed. It’s not clear what causes it, but the disease can be both painful and debilitating. According to the Mayo Clinic’s website, it typically strikes people between the ages of 20 and 30 and those who have a close relative with the disease are much more likely to develop it. There is no known cure, but there are therapies that can help people live a normal life, even put the disease into life-long remission.

As a former swimmer and current coach, one thing that’s always touched me about this sport is it’s enduring sense of community and fellowship. No matter where or what you swim, we can all relate to each other at the most basic emotional and physical levels: Elation, exhaustion, pride, disappointment, surprise, and ecstasy. Most of us have been on the same type of roller coaster ride, whether that ride takes place at the Olympic Games or the Junior Olympics. And when the unexpected strikes any one of us, all of us can imagine how that person feels.

Kalyn Keller may be leaving the swimming pool and the open water behind, but she isn’t leaving the swimming community.

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Restroom access no joke for sufferers by Laura Berman of The Detroit News Online

Last week, I took a swipe at legislators who couldn’t pass a budget but had time to “hash out legislation that will require stores to open their restrooms to the public.”

My comment was a stream-lined bathroom joke, a cleaned-up way to suggest that a law about bathrooms has to be trivial.

I apologize.

In her six-year fight to write this legislation and get it passed, Jill Sklar has heard plenty of dumb, insensitive jokes about the Restroom Access Act and, as she wrote me, “I am sick of it.

“For some reason, you think it’s laughable when a legislator takes the time to finally get it right and do something for those of us who would otherwise suffer in silence.”

Battling Crohn’s disease

Sklar, a Huntington Woods-based writer who battles Crohn’s disease, did not intend to become an advocate for people with serious gastrointestinal disorders. But she has lived through five surgeries that truncated her colon and small intestine, “adopted all lifestyle modifications possible, all to no avail in trying to control this monster inside of me.”

One of the consequences of the disease is that when she needs to use a restroom, she doesn’t have a lot of time for exploration. “It is incredibly embarrassing,” when there isn’t time to find one, she says.

Six years ago, Sklar, 38, who runs a six-minute mile and keeps up with her 11-year-old son, approached her state representative, Andy Meisner, D-Ferndale, and asked for help in getting a law passed that would give people suffering from colitis, irritable bowel syndrome and similar disorders access to employee restrooms in stores when public restrooms weren’t available.

Last week, amid a few remaining jokes and winks, in Meisner’s final term, the House passed the bill. “I think as soon as people listened to the testimony and understood that these conditions are god-awful” they supported it, Meisner said.

Humiliation cited

A formal House Commerce Committee hearing last month went a long way toward proving the case, he said: Sklar and others testified, often with tears in their eyes, about facing humiliation that could easily be prevented.

By then, he’d redrafted the bill to lessen the burden on shopkeepers, requiring ailing customers to carry a prescription from a physician, making it more difficult for them to sue in case of injury, and allowing store owners with fewer than three employees to opt out.

The Michigan Retailers Association enthusiastically backed the bill. Three states have passed similar laws in the last year, without opposition.

Meisner says retailers like the bill, because it will enable people like Jill Sklar to shop in Michigan stores rather than at home, on the Internet.

“It’s pro-business and pro-human,” he says.

Next week, the state Senate will have its chance to pass the Restroom Access Act, a move that could effectively change some lives for the better, improve Michigan retailers’ business and end the potty jokes in one merciful vote.

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Yesterday I decided that Kate has dumbbells (other than myself and the two cats) in the house and I was going to make use of them.  I did a couple of things I remembered from the gym, however I am sure I did them wrong and or did too much work on a specific muscle group.  I also tried to do push-ups.  This was depressing as I know prior to Crohn’s I could do around 50 – 75 without a problem and now 10 makes me sweat.

My goal is not to be big and beefy, but I do need to be a bit more in shape.  I don’t feel the need for people to look at me and say, “Wow, that guy is in good shape” but I want to make sure I am as healthy as possible physically within my control as the Crohn’s will always be out of my control.

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By the time Dr. Burrill Crohn officially described the disease that bears his name in 1932, inflammatory bowel disease — an umbrella term for Crohn’s disease and the related condition known as ulcerative colitis — had afflicted sufferers for centuries.

Alfred the Great, considered the first king of England, ascended the throne in 871 and defeated the occupying Danes more than once, demanding equal rights for English citizens of Danish territory. He built towns and schools and was an accomplished diplomat who put limits on blood feuds and upheld strict penalties for oath-breakers.

And, if the suspicions are true, he had Crohn’s. A contemporary biographer reported that he suffered a chronic illness that caused him discomfort and embarrassment and pain when he ate. Ninth century explanations for what Alfred had included the curses of witches or divine punishment for his philandering.

President Dwight D. Eisenhower had Crohn’s, and his physicians prescribed a bland diet. But sometimes Eisenhower couldn’t resist forbidden foods such as pig knuckles and sauerkraut. He had surgery for bowel obstruction in 1956, months before winning his second term in office.

During the second half of the 20th century, understanding and treatment of inflammatory bowel disease has advanced considerably:

Until the 1950s, doctors thought it was psychological and, accordingly, treatment focused on psychoanalysis.

It wasn’t until the 1960s that scientists started to consider the immune system as a source for the disease.

Before the 1970s, doctors dismissed the fact that it runs in families as mere coincidence.

For decades, Crohn’s and colitis research was stymied by the lack of an animal model. Scientists tried, and failed, to induce colitis in animals with vitamin deficiencies and bacterial toxins.

Then, in 1981, scientists identified an animal that naturally develops human-like colitis: the cotton-top tamarin, a monkey found in Colombia. The first mouse model was developed in the 1990s, allowing research to progress at a faster rate.

– Amber Dance

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