Awesome Opinion on FDA, Crohn's and Osiris

Written by Gideon J. Sofer- University of California, Berkley student - from WSJ

Right now there are millions of individuals whose lives are directly dependent on the rate at which new drugs come to market. I'm one of them. I'm fighting for my life.

To date, half of my intestine has been removed to manage Crohn's disease. Last year, at age 23, I enrolled in a clinical trial for a treatment that could save my life: an adult stem-cell therapy that helps damaged intestinal tissue regenerate from the relentless inflammation and scarring caused by Crohn's.

The sponsor, Osiris Therapeutics, reported that Crohn's patients in the therapy's Phase II trial all experienced clinical improvement after receiving the cells. A Phase III trial for the treatment is now nearing completion, but Food and Drug Administration (FDA) approval could be years away, despite its FDA "fast track" designation.

In accordance with antiquated FDA policies, the Phase III trial is randomized with three groups of patients, and double-blinded, which means neither the doctors nor patients are told what treatment is being administered. One group received full-strength stem cells, another received half-strength, and a third got a placebo (the proverbial "sugar pill"). It appears I got the placebo.

Foregoing all other treatments, I received the four scheduled infusions, and yet my disease progressed with a vengeance. In a matter of weeks, I became dangerously malnourished. I've since been readmitted to the hospital countless times, as my doctors continue to plead with Osiris for information. But Osiris has refused, citing adherence to FDA protocol.

I am now a lab rat. I have no right to know what happened to me in the study, nor do I have a right to try the promising treatment as my health deteriorates. It doesn't have to be this way.
Under the Fifth Amendment's guarantee that "No person shall be deprived of life, liberty or property without due process of law," a critically ill patient should have access to a potentially lifesaving drug that has been deemed safe for human consumption, if the patient agrees to bear the risks involved. But earlier this year, the Supreme Court refused to hear a case on the issue, denying countless patients their right to pursue life.

Thankfully, some members of Congress have stepped in to ensure our rights as patients. In May, Sen. Sam Brownback (R., Kan.) and Rep. Diane Watson (D., Calif.) introduced the Access, Compassion, Care and Ethics for Seriously Ill Patients Act. If passed, this bipartisan legislation will begin to restore the rights of millions of patients by widening access to promising investigational drugs.

Human clinical research is an intricate scientific and moral process, but it does not justify taking immoral advantage of patients. Tragically, FDA and Osiris think it does.

Typical approval protocols almost always guarantee patients taking the placebo access to the actual drug -- at the very least -- after the study has ended. But in what appears to me a deliberate act of cruelty, Osiris hung its patients out to dry without any recourse, refusing to confirm which patient got what. The FDA has endorsed Osiris's decision by enabling it to proceed with the study.

Withholding a potential cure is just as bad -- if not worse -- than the potential death sentence of a serious illness. If patients like myself have the audacity to put their lives on the line for the betterment of science and those in their predicament, their decision should not only be embraced, it should be rewarded.

Furthermore, trials without ethical recourse can lead to inadequate and incomplete data, compromising the integrity of the study. If trial patients are treated like lab rats, they won't feel obliged to cooperate unconditionally and report accurate data -- something the FDA and the drug industry rely on heavily, but have failed to consider.

Everyone agrees it is a fundamental right for patients to dictate their course of treatment with FDA-approved drugs. So why do the rules evaporate at the most critical moment, when the only life-preserving options are highly promising investigational drugs?

Crohn's Disease, Stress and Losing your job!

Yeah, so how is this for a recipe for a Crohn's Disease Flare Up:
Holidays + Financial Issues + Ending Stem Cell Study Due to Ineffectiveness + Losing your job 3 days before Christmas. So yeah, I will be again testing the theory of stress causing a Crohn's Flair up!

Awesome, yes my stress level just rose again. I just lost my job 3 days before Christmas. Anyways, should give me some more time to write some informative and entertaining posts for my Crohn's Disease Blog! Update coming soon. Merry Chistmas to you all. God bless and say healthy.

Oh, and if anyone needs any website work or online marketing, let me know and I can send you a portfolio or we can chat!

Done with Osiris Prochymal Stem Cell Experiment

So yeah, my round 2 of my Osiris Prochymal infusions didn't go so well. My Crohn's has been flaring even worse since the second phase started. Literally hours after the infusion I started flaring and haven't been right all week. Tremendous pressure in my stomach and gas (signs of a potential blockage). So I am abandoning the final infusion and assuming this round I got rerandomized as a placebo. It happens with trials, but not worth a couple more hours of sugar water. Got a script for Entocort steroids to try to quell the Crohn's flare up. I should be frustrated, but I honestly am not. It's all part of God's plan and I am just gonna keep rollin on. Back to the drawing board when I visit Dr. Shafran on Monday.

Osiris Prochymal Round 2, Treatment 2

Going back to Dr. Shafran today for my second treatment in round 2 of my Osiris Prochymal stem cell treatment for Crohn's. I don't feel so hot after the one I had Monday so we'll see what happens. I guess when you get a few million stem cells you are bound to feel a bit different. Keep your fingers crossed and thanks for the support!

New David Garrard Crohn's Interview

From Bob Sansevere of TwinCities.com
Jaguars quarterback David Garrard has learned to live and play pro football with Crohn's disease

It was the offseason, and he was losing weight. He didn't know what was wrong. It was 2004 and, even after being told he had Crohn's disease, Jacksonville Jaguars quarterback David Garrard wasn't sure what that entailed. He learned soon enough he was dealing with a bowel disease in which the lining of one's digestive tract becomes inflamed, causing severe diarrhea and abdominal pain.

This season, Garrard is taking part in the "In the Zone For Crohn's" program, which involves a $10,000 donation to the Crohn's & Colitis Foundation of America for every touchdown he scores or TD pass he throws. I talked Tuesday with Garrard about living with Crohn's.

BS: How is your life affected by the disease?
DG: Right now, I'm doing great. I don't have any signs or symptoms or anything. I can pretty much lead a normal life. The medication I'm on and the surgery I had four years ago have helped keep me symptom free.

BS: How would you deal with Crohn's if it acts up during a game?
DG: It's been four years now, and I go in and get a wonderful colonoscopy every year. It's been clear every year. I don't worry about it anymore. I'm not going to let it have control over my life. If it comes back, I'll have to do something else about it.

BS: Did you ever worry the disease could keep you from playing in the NFL?
DG: When I first heard about it, I didn't know it was anything. I thought the doctor would give me some pills and I'd be done with it. I learned it was more severe. After me and my wife started researching it, and people heard I had it and started sending me information. I started to get concerned. It's not something you can play with if you deal with it on a day-to-day basis. I lost about 40 pounds. I said I want to do whatever it takes to heal myself and get the disease out of me. Having surgery and medication helped.

BS: What was involved in the surgery?
DG: They removed about a foot of my intestines. There's no cure for Crohn's. Crohn's can come back. After six months, Crohn's was coming right back. I went on a medication, Remicade, and I haven't had anything since. I've been normal.

BS: You were losing a lot of weight. Before you knew what the problem was, were you afraid you were dying?
DG: Definitely. When I lost all that weight was when I was just trying medicine to heal it. It was so far advanced. The body has disease on the inside of the intestines.

BS: Is Crohn's a disease that people need to learn not to be embarrassed about?
DG: That's why I feel the Lord has blessed me with it. I'm not afraid about it. I'm not shy about it. But a lot of people are shy about it. It's tough being in middle school and high school and having to go to the bathroom a lot or vomiting a lot. Kids are not comfortable with that. Adults are not comfortable, either. If you say cancer or AIDS, everybody knows what you're talking about. If you say Crohn's, people don't know what you're talking about. I've met a lot of kids who are dealing with it. I met a kid last week from Make-A-Wish, and he wanted to come down from New York to meet me.

BS: A little football talk: There was talk that last week's game against Tennessee was a make-or-break game for the Jaguars. You lost that game. So what does that make Sunday's game against the Vikings?
DG: We're pretty much in playoff mode right now. We've got to win every game from here on out to give ourselves a shot to go to the playoffs

BS: As you know, your assistant head coach/tight ends used to be the Vikings' coach. How is Mike Tice to work with?
DG: He's great. He really understands the game. He knows exactly what he's talking about. He's a fun guy. He's very, very helpful. He wants to help every position.

BS: What helpful advice has Mike Tice given you?
DG: Just be myself and play my game. Not try to go outside of what I normally do. He had Daunte Culpepper, a quarterback he loves to death. He always talks about him. He said Daunte would do what he could do and not try to please everybody. Just get the job done.

7 Natural Solutions to Contolling Crohn's Disease - Living with Crohn's

7 Steps to Controlling Crohn's Disease

For people with digestive issues, life tends to revolve around what you can and can't eat and how far away from the nearest bathroom you dare to venture. That's certainly the case with Crohn's disease, which along with ulcerative colitis is one of the two most common forms of inflammatory bowel disease. Symptoms include wrenching stomach pain soon after eating (typically in the lower right side) and relentless diarrhea. It's relatively rare, but a new research finding suggests that people with Crohn's are seven times more apt to carry bacteria that cause a related gastrointestinal disease in cattle. The bacteria -- Mycobacterium avium subspecies paratuberculosis or MAP -- has been found in milk in American supermarkets, and some studies have found it in meat and cheese, raising the possibility that it may be passed up the food chain to people.

IT'S GUT WRENCHING
Whether or not bacteria such as MAP cause disease in the intestinal tract is largely a matter of threshold, explains Daily Health News contributing editor Andrew L. Rubman, ND. A person with a healthy, intact digestive tract will likely be able to resist infectious bacteria. But the large intestine is the body's center of immunity, and when the digestive tissue becomes damaged and inflamed, it becomes more susceptible to invasive microorganisms, be it MAP or the increasingly infectious species of E. coli, Salmonella, and other causes of food poisoning. If the balance of healthy versus harmful bacteria is disrupted and/or tissue is damaged, people become less able to resist disease and it becomes more difficult to treat. Dr. Rubman and I talked more about Crohn's disease in general, and about natural support for people with this problem. What causes Crohn's Little is known about the causes of Crohn's disease, although family history, an overactive immune system and inflammation response, and environmental triggers are all believed to play a role.

It differs from ulcerative colitis (which causes similar symptoms) because inflammation is deeper in the intestinal wall and also potentially affects the entire gastrointestinal tract from mouth to anus. Ulcerative colitis primarily affects the colon and small intestine. There's no known cure for Crohn's and remedies offered by conventional medicine are riddled with problems. In September 2008, the FDA ordered stronger warnings for common Crohn's drugs -- infliximab (Remicade), adalimumab (Humira) and certolizumab pegol (Cimzia) -- after an association with the risk of developing fungal and yeast infections such as Candidiasis was found. Because conventional treatments have significant side effects -- even when they work, and they don't always -- more than half of people with Crohn's disease turn to natural therapies.

NATURAL SOLUTIONS

Since Crohn's disease affects different people in different ways, Dr. Rubman individualizes treatment for each patient, working in collaboration with his/her gastroenterologist -- a strategy he suggests for all Crohn's patients since a combination of natural and mainstream treatments seems to be most effective. Dr. Rubman's natural solutions include...

1. Probiotics.
Health requires maintaining a balance between good and bad bacteria in the digestive tract. Poor diet, stress or a digestive disorder such as Crohn's can result in a takeover of the system by "bad" bacteria, resulting in symptoms such as diarrhea and gas. To restore a proper floral balance, Dr. Rubman frequently prescribes a seven- to 10-day course of a probiotic supplement composed of Lactobacillus acidophilus and Bifidobacterium bifidus. However, he notes that it is important to have a stool test before treatment, in order to ensure the proper probiotic formula is administered.

2. Fish oil.
A small British study found that fish oil taken with antioxidants may help reduce the inflammation associated with Crohn's disease. Eat fatty fish such as salmon, mackerel or sardines two or three times a week. In addition, Dr. Rubman often prescribes one or more grams of an EPA-DHA fish oil capsule or liquid daily.

3. Vitamin B-12.
When the bowel has been damaged by Chron's disease, it may no longer effectively absorb B-12. If you are tired and rundown, ask your doctor to test you. Dr. Rubman prefers to prescribe sublingual B-12 rather than B-12 shots. "It's as effective, less expensive and certainly more comfortable," he notes.

4. Acupuncture.
Acupuncture has traditionally been used to treat inflammatory bowel disease in China and is meeting with increasing mainstream acceptance in the US. A small German study suggests that acupuncture may help improve quality of life and general well-being in people with Crohn's disease by modulating symptoms and may even result in a small decrease in inflammatory markers in the blood. Find an acupuncturist in your area at the Web site of the American Association of Acupuncture & Oriental Medicine at http://www.aaaomonline.org/45000.asp.

5. Focus on whole foods, fresh fruits and vegetables.
A diet that contains lots of processed and fast foods -- like white bread, sugary desserts, etc. -- stresses the bowel and may trigger inflammation and worsen symptoms of Crohn's disease. Disease-causing microorganisms thrive on foods like these. Many people with Crohn's report that they feel better when they eliminate or significantly cut back on processed foods and place a greater emphasis on whole foods, fresh fruits and vegetables and moderate amounts of protein. Avoid milk and dairy products as well as trans fats, as they can also irritate the intestinal track.

6. Decompress.
Many people with Crohn's find that their symptoms worsen during stressful periods. If you find this to be the case, take steps to effectively manage stress. Do whatever works best for you -- whether that is yoga or meditation or dancing or tennis.

7. Stay away from colonics.
Many people are tempted to turn to this "quick fix," but Dr. Rubman warns that colonics can backfire and worsen symptoms. The large intestine requires a healthy balance of microorganisms to function properly, and colonics indiscriminately wipe out the good with the bad under the thinly supported premise of detoxification. To feel more in control of your disease and your life, learn more about Crohn's and connect with others who are going through the same things you are. Join message boards, chats, blogs and support groups (online or offline) at Web sites such as http://www.ccfa.org/, or those listed at http://www.crohns-disease-and-stress.com/support.html and http://ibdcrohns.about.com/od/onlinesupport/a/supportgroups.htm. Acknowledging that a diagnosis of Crohn's disease is never good news, Dr. Rubman urges those who have the problem to be optimistic -- it can often be controlled without drastic drugs or a draconian diet, and quality of life need not suffer.
Source(s):
Andrew L. Rubman, ND, director, Southbury Clinic for Traditional Medicines, Southbury, Connecticut.
American Society for Microbiology, http://www.asm.org/