User:Crohnie/Sandbox

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[edit] Read and learn

Regards CD and pregnancy, note that WP:MEDRS applies and popular press should not be linked. Pubmed has lots of information (i.e. [2]) and a simple search with Crohn and pregnancy turned up 58 articles, each with an abstract. Each pubmed article is also accompanied by a pubmed number (next to the PMID) which can be used to generate a citation template very easily using diberry's citation generator. Also the Google scholar autocitation, a google-style search engine and reference generator, is very useful when the article doesn't have a pubmed number (old, social sciences or humanities). Also, wikipedia is not a how to manual, so information on how to read bloodwork isn't really appropriate (and I don't think http://www.bloodbook.com meets MEDRS). Crohn's disease is a valid medical diagnosis, so it's important to provide the best medical information available from the most reliable sources. Accurate and reliable information is the most useful thing for wikipedia's readers, and that is available primarily from peer-reviewed journals. WLU (talk) 19:36, 13 February 2008 (UTC


http://en.wikipedia.org/w/index.php?title=Wikipedia:Administrators%27_noticeboard/Incidents&curid=5137507&diff=194629446&oldid=194629393#Vandals_flooding_RfB_with_self-noms.21 --CrohnieGalTalk 16:11, 28 February 2008 (UTC) http://en.wikipedia.org/wiki/Wikipedia_talk:RFA

http://en.wikipedia.org/wiki/Wikipedia:Administrators%27_noticeboard/Incidents#Wrong_Planet_on_autism_articles_again --CrohnieGalTalk 04:06, 23 March 2008 (UTC)


[edit] From Natalizumab archive 1

http://en.wikipedia.org/wiki/Talk:Natalizumab/Archive_1#.22compare_the_drug_with_others_in_its_class.22_-_per_MEDMOS

  1. "compare the drug with others in its class" - per MEDMOS

MEDMOS / drugs - http://en.wikipedia.org/wiki/Wikipedia:MEDMOS#Drugs - guides that Drug pages be written - "For example, a long list of side effects is largely useless without some idea of which are common or serious. It can be illuminating to compare the drug with others in its class...." Accordingly:

- Multiple Sclerosis DMD class

  • Avonex - mention of liver side effects confined to single sentence in the middle of "Overview" section, despite Primetherapeutics; no mention of PML, even though the 2 patients who got PML in the N trials were on Avonex; no mention of any safety issues in the lead.
  • Rebif - same as above, (with the exception that PML has not been linked to it).
  • Betaseron - speaks only of beneficial effects, liver issues not mentioned anywhere
  • Glatiramer acetate - issues are confined to a single section; nothing in lead
  • Mitoxantrone - side effects in sngle section; despite absolute limit on usage due to cumulative heart damage - no mention in lead

- Crohns Disease DMD class

  • Infliximab - despite black box and multiple FDA warnings, safety issues confined to a single section, and nothing in lead. Although linked with PML, this is not even mentioned. Article is generally glowing, which it should, given the versatility.
  • Adalimumab - despite black box and FDA warnings, safety issues confined to a single section, and nothing in lead.

- Drugs linked to PML

  • Rituximab - despite black box and multiple FDA warnings, safety issues including PML confined to a single section. Nothing in lead. Interesting becase this is the best hope for a PPMS treatment.
  • Chemotherapy - obviously countless die from it's toxocity, but no mention of safety is lead. Immunosuppression and myelosuppression titles a sub-section.
  • Corticosteroids - this is class of drugs with inevitable serious side-effects - but nothing in lead, and very little mention on page - no meniton of PML anywhere.
  • Tacrolimus - thousands die post-transplant from immune suppression, but no mention of safety is lead. Immunosuppresion following transplantation titles a sub-section.
  • Avonex - see above.

- Conclusion - of 11 comparables, none of their Wiki pages seem close to the layout of the N page - this supports my thesis of WP:NPOV / WP:UNDUE problems.....io-io (talk) 20:01, 22 March 2008 (UTC)

2. Here is a alphabetized list of ten other drugs that were also withdrawn from market, with short explanations of how this important fact was handled in those articles:

  • Alosetron: Withdrawal from market mentioned in first paragraph. One-third of short article is about withdrawal and serious side effects.
  • Cerivastatin: Second sentence. Entire third and fourth paragraphs (amounting to more than two-thirds of entire article).
  • Cisapride: Withdrawal and warnings featured "above the scroll" (seventh and eighth sentences).
  • Fen-phen: Every single sentence in the entire article, except the first one, is about side effects and withdrawal from market.
  • Rapacuronium: Third of three sentences: one-third of stub about withdrawal.
  • Rofecoxib: Entire third paragraph. Enormous section on side effects, plus sections on withdrawal from market and lawsuits.
  • Tegaserod: First (and only) section after the lead is entirely about withdrawal from market.
  • Thalidomide: Entire lead, except first sentence. In fact, the overwhelming majority of the article is about its withdrawal from market.
  • Troglitazone: Second sentence in lead about side effects. Third (out of only seven sentences) is withdrawal from market.
  • Zimelidine: Second paragraph entirely about withdrawal from market.


[edit] Clinical trial results

http://www.ccfa.org/printview?pageUrl=/about/news/trialupdates Many companies have been releasing news about the results of the clinical trials they have been conducting on various new therapies for Crohn's disease and ulcerative colitis. Here are some of the latest trial results.

ALICAFORSEN (ISIS 2302) Results of the trials for alicaforsen (also known as ISIS 2302) have been released by Isis Pharmaceuticals. The drug shows definite promise in ulcerative colitis. Three separate Phase II studies were done to measure activity and duration of response, and to determine the appropriate dose for a larger, Phase III trial. The studies — one a placebo-controlled study, one to test how the drug performs in the body, and one to compare it to the effects of mesalamine — found that patients who received an alicaforsen enema each night for six weeks and responded to the initial treatment were able to keep that response for up to six months. Also, the alicaforsen enema treated patients had improved mucosal healing, decreased rectal bleeding and decreased stool frequency. In the trial where alicaforsen was compared to a mesalamine enema, it was found to achieve improvements in the disease equal to or better than mesalamine for a longer period of time. A recent small open-label trial also showed that alicaforsen enema improved clinical symptoms and pouchoscopy appearance among patienst with chronic, unremitting, pouchitis. The drug was found to be well-tolerated in all the trials. Alicaforsen belongs to a new class of antisense drugs which act by being mirror images of the messenger RNA or building blocks which the body uses to produce various inflammatory proteins or molecules. This drug inhibits a molecule known as ICAM-1 that plays a key role in intestinal inflammation. Unfortunately, alicaforsen was shown not to induce remission in Crohn's disease, but Isis is committed to developing the drug for ulcerative colitis. Remember — keep visiting the CCFA Clinical Trials section for the latest information on the Phase III ulcerative colitis trial.

NATALIZUMAB (FORMERLY ANTEGREN) The FDA recently approved natalizumab (formerly known as Antegren) for the treatment of multiple sclerosis. Natalizumab is now known as Tysabri,® and is currently undergoing Phase III trials in Crohn's disease. In September of 2004, Elan Pharmaceuticals filed for approval of natalizumab with the European equivalent of the FDA for use in Crohn's disease, based on a completed Phase III study for induction and maintenance of remission. The large initial induction study known as ENACT-1, which enrolled 905 patients with Crohn's disease, did not show significant benefit over placebo, possibly due to a higher than expected response rate among those patients assigned placebo. However, the subsequent maintenance study known as ENACT-2 showed significant benefits among patients who received 300mg infusions every 4 weeks in terms of clinical remission, response and ability to stop steroids. A second Phase III study is ongoing, and once those results are available, natalizumab may undergo FDA review and approval. This drug is an antibody that inhibits a specific 'adhesion' molecule on certain immune cells, preventing them from migrating from the blood stream into the intestines and adhering to the intestinal lining, which is a major cause of inflammation in Crohn's disease.

MESALAMINE (High Dose Asacol) Results of the first trial confirming that larger doses of mesalamine would be effective for patients with moderate ulcerative colitis was reported at the American College of Gastroenterology Annual Meeting held in early November. A new tablet formulation of mesalamine (Asacol®) 800 mg, instead of 400 mg, will allow patients to take only six tablets a day instead of 12, once it is approved by the FDA. "This was really the last phase of data needed to move forward with a higher and more convenient dose for the patient," says Dr. William Sandborn, one of the investigators of the study. The study, sponsored by Procter & Gamble Pharmaceuticals, was a multicenter clinical trial of 268 patients with moderately active ulcerative colitis.

ADHESION BARRIER (Seprafilm) Patients who undergo abdominal surgeries run the risk of having adhesions. Adhesions are basically scar tissue that sticks to another organ or other tissues. For IBD patients, these adhesions can lead to small bowel obstructions after colorectal surgery. Genzyme manufactures a bioabsorbable membrane known as Seprafilm® to be used in abdominal surgeries, and recently concluded a trial to determine whether or not the use of Seprafilm® could reduce the risk of complications from adhesions. The study found that by using this membrane during an initial surgery, the relative risk of small bowel obstruction due to adhesion could by reduced by 47 percent.

Some of the trials listed here were featured in CCFA's Clinical Trials section. More than 80 new therapies are being developed in the pipeline for inflammatory bowel disease. Click here to check the trials section frequently to keep up to date. Although it can sometimes take a long while before trial results can be accurately reported, only your participation can help develop these new therapies!

[edit] Tysabri approved for treatment of Crohn's disease, with restrictions

http://www.ccfa.org/reuters/tysabriapproved

Last Updated: January 15, 2008 (Reuters Health)


WASHINGTON (Reuters) - Biogen Idec and Elan Corp won U.S. approval on Monday to market their drug Tysabri (natalizumab ) for treating Crohn's disease.

The drug is already sold for treating multiple sclerosis with tight restrictions and a strong warning about a potential for progressive multifocal leukoencephalopathy. The companies must put similar limits on sales for Crohn's disease, the Food and Drug Administration said.

The FDA approved Tysabri for adults with moderate to severe Crohn's disease who have evidence of inflammation and have a poor response to, or cannot take, other therapies.

In one Elan-sponsored study, 60% of Tysabri patients responded to treatment after 12 weeks of therapy, compared with 44% who got a placebo.

Another study tested patients who initially responded to Tysabri, following them for an additional year. Fifty-four percent of Tysabri patients had a sustained response through 12 months, compared with 20% of placebo patients, Elan said.

Tysabri is an "important step" in treating Crohn's but "one that carries serious risks," said Dr. Joyce Korvick, deputy director of the FDA division that reviews gastroenterology drugs. "Health-care providers must carefully monitor patients for these risks," Dr. Korvick told reporters by telephone.

Sales of the drug were suspended in 2005 in response to three cases of progressive multifocal leukoencephalopathy, or PML. The drug returned to the market in 2006 with limits after the FDA decided MS patients were willing to accept the risks in light of possible benefits.

Dr. Korvick said the FDA ordered similar restrictions for Crohn's sales as it did for MS. Among them, patients must acknowledge risks and agree to be monitored for problems.

FDA reviewers in the past have estimated the risk of developing PML is 1 in 1,000 over 18 months of Tysabri use, but caution the calculation could change after more experience with the drug. There is no known treatment for PML, which is usually fatal within six months.

The companies expect Tysabri will be available to Crohn's patients by the end of February, Elan said in a statement.

European regulators have recommended against use of Tysabri for Crohn's disease. Biogen and Elan have said they expect a final decision from the European Commission during the first quarter of 2008.

Date Posted: January 18, 2008 Last Updated: January 15, 2008 (Reuters Health)

[edit] Notes

Other serious allergic reactions along with multifocal leukingephnalopathy (PML) include but are not limited to; hives, itching, trouble breathing, chest pains, dizziness, chills, rash, nausea, flushing of the skin, low blood pressure. Allergic reactions usually happen 2 hours from the start of the infusion but can happen anytime.

Other side effects;headaches, urinary tract infections, lung infections, pain in arms and legs, vaginitis, feeling tired, joint pain, depression,[diarrhea]], rash, and stomach pain.

(Personal note with my own health regarding these side effects, I wouldn't be able to know if I was having a side effect since I already have most of the listed side effects now do to my Crohn's disease, COPD and arthritis. At this point of my research, I have to say I would not try this medication until it has been in use for a much longer period of time.)

http://www.fda.gov/medwatch/safety/2008/Tysabri_dhcp_letter.pdf reported liver injury Hepatotoxic-signs of liver injury including marked elevated serum hepatic enzymes and elevated total bilirubin has occurred as early 6 days of the first dosing and even after multiple dosing.

After reintroducing natalizumab, the liver injury returned providing evidence that Tysabri (natalizumab) caused the liver injury. The combination of transaminase elevation and elevated bilirubin without evidence of a blockage is generally recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant. Patients should discontinue if signs of jaundice and/or laboratory test show problems occurring.


[edit] Remicade

http://www.remicade.com/remicade/assets/Med_Guide.pdf

http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a604023.html


[edit] FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01811.html

http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.htm


[edit] Possible info for IBD articles

[edit] Famous people with IBD-Crohn's specific

http://crohn-colitis.hu/eng/famous-people-with-ibd.php Famous people with IBD (Lord, find a better site than this. This is written horribly!) http://en.wikipedia.org/w/index.php?title=Talk:Crohn%27s_disease&curid=173689&diff=211887586&oldid=211886526

Look up each person and do research to see if and/or how it affected their abilities to continue on with their success.
Also, make sure it's Crohn's they are dealing with.
Make sure that any information follows the strict policies of WP:BLPN (of course other policies too but this is one I don't want to forget to think about.)
<quote> Obviously however, WP:NPOV requires neutral reporting, so it would have to reflect that the people have CD and not 'and look what they've done'; the only real detail I could see that could be included as an extra is how the disease has actually affected their personal or professional lives. WLU <end quote> If questions about BLP, Avb might be able to help, if not use the board and ask.
  • Research notes:

[edit] Crohn's disease and Chicken Pox

http://home.clear.net.nz/pages/ccsg/CpoxandCD.html CD and Chicken pox

  • research notes:

[edit] Check out talk page, maybe reactivate conversation to a consensus

http://en.wikipedia.org/wiki/Wikipedia:TOV

[edit] Talk:Chiropractic

http://en.wikipedia.org/wiki/Talk:Chiropractic#Improved_version_RfC

http://en.wikipedia.org/w/index.php?title=Talk:Chiropractic&curid=197022&diff=212732238&oldid=212730284#Recent_edits_made_without_discussion (Specific comment uncalled for? " I am typically against edit warring and I wouldn't ask you to participate in one, but I felt like QuackGuru was allowed to steamroll his version through, emboldened by supposedly "outside" editors (the usual gang of editors ready to do anything to bash CAM topics such as Chiropractic).")

http://en.wikipedia.org/wiki/User_talk:Dematt#NPOVing_Chiropractic (comments by CortiSpinal)