Showing posts with label treatment. Show all posts
Showing posts with label treatment. Show all posts

Wednesday, November 13, 2013

FMT & How This Treatment Will Evolve

Another report on poop that's not that shitty.  The only stuff that smells in this article is the way the AMA and FDA have responded (or lack thereof) to FMT's.  This post is about good ol' FMT's or otherwise known as - Fecal Matter Transplant's, if you're not familiar with the abbreviation. I prefer FMT when talking about this.  
So yeah, this is an article that I found on a local CA online publication. It provided a lot of information, so I decided to do a blog on this.  I read a lot of articles about FMT's, with some that have produced study data and some that do not. There's not much data out there to be found, that's probably why.  All of the articles that I have read however, have been on the positive side in regards to the results with FMT's. This is the first article that I have read to date that reports an extensive {if you want to even go that far as to call it "extensive"} follow-up with patients who had received a FMT.  This information is super important in order to show the effectiveness of the procedure and to give people the confidence to consider such a treatment.  People get grossed, they just do. It's the way our culture handles stuff like this. The point I want to make here is that because of the lack of testing and trials for FMT's, being able to know if this procedure is effective and safe, is to follow-up with patients that have been treated with FMTs. Those patients, in a sense, will provide helpful and needed information that cannot be found in clinical trial data because the data doesn't exist.   This procedure is so new {well,to us Westerners that like to deny and refuse anything "natural"} and not tradition, the patients receiving this treatment are essentially the trial subjects. Seriously, there should be a consent that patients must sign before they receive this treatment that allows the doctors to use their information anonamously, especially follow up data, so it can be published for learning purposes.  To have that information available is crucial.  We are talking about working with US FDA here! As we have seen and continue to see, the FDA doesn't always make the most logical/reasonable decisions in the best interest of the people.  To be able to show data that makes a difference, will make this life saving treatment available to people that would otherwise die. There is no reason why there should be  hundred of thousands of people suffering from c-diff, thousands who end up dying and BILLIONS of dollars spent on ineffective treatments!  That's insanity when there's a treatment that has shown to be 90% effective.  
A patient that suffered from c-diff states the following -  "It's a beast that keeps storming back," he said. "It affects the mind and emotions, too — 90 percent of serotonin is in the gut. You worry quite a lot."  The doctors in this article state that the infection disrupts a person's life.  Doctor Stollman states that FMT's are "the most patient-driven treatment he's encountered in his twenty-plus years of practicing medicine".  It's not surprising that when you have a condition that won't go away, no matter how many rounds of treatment you take, that people end up seeking out the strange and unusual if it means being healthy again.  
The AMA needs to make a billing code !  Doctors need to get paid for treating people AND  doctors need to consider offering FMT's as an option that they know they will get paid for.  After all, the FDA has allowed people with a difficult case of c-diff to get treated with this procedure.  Which means = if you're most likely going to die from c-diff, THEN you can receive the treatment. *smh* Yup, only if you have suffered long, spent a lot and have no more fight in you, will you be able to get an effective treatment.  Does this make any sense whatsoever?  
One last point.  The 4 patients out of the 77 that were followed up with after the FMT who had developed one of the health issues listed (I highlighted the paragraph in purple), in my opinion probably has no relationship to the FMT.  People could have other health issues brewing that just happen to appear after this procedure.  The 4 health conditions are all very different from each other which also leads me to believe that these illnesses weren't brought on by the FMT.  I just feel that as long as the sample donor is screened and cleared for all the diseases that could make a donor  not qualified, then the chances of something negative happening is probably very low.  It's like receiving blood.  The benefit of getting it is high (because if you're getting a blood transfusion, there's a need for it) and the risk is low. Whether it's in a form of transplant or pill, if  it makes people better, this should start to be considered THE most effective treatment rather than the alternative when all else fails.  That's my take on it. 

Sunday, October 06, 2013

REDHILL BIOPHARM - News -> RHB-104 - Possible Breakthrough Treatment for Crohn's Disease


I get so excited when I read about this possible treatment, RHB-104, for Crohn's!  I've been watching this drug for over a year now.  This is a  treatment that if approved by the FDA, I will be jumping on it as soon as it becomes available.  No doubt!  This is the kind of treatment we need.  Everything else just treats symptoms.
So, why is this so exciting?  If you read current research about what causes Crohn's disease, you will see that researchers are leaning away from considering Crohn's disease an autoimmune condition.  They have found that there is an underlying cause for the immune response to activate.  Crohn's is said to be caused by a combo of 3 factors - Immune system abnormalities, environmental influences and bacteria.  I just wiki'd Crohn's disease and this is what is said about what is believed to be the cause - "Crohn's disease is caused by interactions between environmental, immunological and bacterial factors in genetically susceptible individuals.[4][5][6] This results in a chronic inflammatory disorder, in which the body's immune system attacks the gastrointestinal tract possibly directed at microbial antigens.[5][7] While Crohn's is an immune related disease, it does not appear to be an autoimmune disease (in that the immune system is not being triggered by the body itself)."
What this means is that people that have Crohn's disease do not have the immune system capabilities to destroy a form of bacteria that have been introduced into the body at some point in time.  As research has indicated, a large number of people with Crohn's disease happen to have the MAP bacteria in their body somewhere.  The exact location of the bacteria is not known at this time.  Who cares where it is, as long as a treatment is available that will destroy it is my opinion.
See why this makes me super hopeful?  If Crohn's is caused by this MAP bacteria & if this new combination antibiotic eradicates the MAP bacteria from people with Crohn's disease, this could be the answer to the Crohn's disease epidemic!  Can someone say CURE :)
Wouldn't that be glorious?  

Clinical trial for a new antibiotic therapy for Crohn’s treatment started:
Crohn’s disease is an inflammatory bowel disease which may affect gastrointestinal tract from mouth to anus, and has a wide variety of symptoms. Mycobacterium avium subspecies paratuberculosis (MAP) is believed to be associated with Cronh’s disease. Professor Dr. Saleh Naser, UFC College of Medicine, believes that MAP is the cause of the disease. He said, "Crohn's disease affects more than 750,000 Americans, yet traditional treatments only address the symptoms of inflammation and not the cause." He further added, "I have seen case studies where patients' lives have been restored following treatment, which removes MAP. I have high hopes that this clinical trial may lead to finding a cure." Dr. Saleh Naser will soon conduct clinical trials on a new antibiotic therapy acquired by RedHill Biopharma for curing the disease. 240 participants will be recruited for this double blind clinical trial.
http://health-beauty-2468.blogspot.com/2013/09/clinical-trial-for-new-antibiotic.html

Monday, September 23, 2013

NEW TREATMENT OPTION - SIMPONI® Receives Approval in UK for the Treatment of Ulcerative Colitis/ #UC

I just read that today Simponi was approved for the treatment of ulcerative colitis in the UK.  This may be a successful treatment option for people that have not been able to obtain remission with mainstream treatments for the disease.  Some people, like myself, have tried them all with no improvement.  It's very frustrating to hit that wall and run out of effective treatments..... actually, safe effective treatments.  If you just can't seem to get the inflammation and toll taking symptoms under control and you've taken into consideration the risks vs. the benefits, some people may find relief with this new drug.  This particular article does include the potential health risks from TNF-blocking therapies, toward the end of the article.  

If you are considering Simponi (or any immunesuppressing drug), please know everything about it before agreeing to the treatment.   Everyone should know what the risks are versus the benefits before beginning any kind of treatment like this.  Your doctor will not tell you everything about these drugs and from personal experience, most doctors down play the risks and don't even look at  family history/genetics when deciding if these treatments are appropriate.   It's disturbing when you know that the information you completed for your file, (providing family history) and screams *HIGH RISK*, and the doctor recommends the treatment anyway.   Sadly, it's probably because the doctor didn't even scan over this little piece of information that says a lot.  Another reason is because TNF-blocking therapies have become the conventional prescribing treatments for IBD now, despite their high side-effect profile.   

Personally, I would never consider being treated with an immune suppressing drug of this potency because of the numerous possible health problems that could result.  It's not worth it to me to put my entire body at risk of developing something life altering (conditions worse than what I'm treating) with the awareness that there are life changes that I can make that will encourage healing and repair of my digestive tract.  It takes determination to make the changes that are necessary and it takes longer to heal, but in my opinion, it's my overall health that I care about.  You will get there, I did.

Most doctors will say that diet is not a big contributor to IBD however,  it infact makes a huge difference in respects to your success with reaching remission. What foods you choose to eat WILL affect your health negatively or positively, it's a decision that you can control that will have a significance on your overall quality of life.  If you struggle with diet and need some guidance, send me an email.  Years ago I was clueless about what to eat and what not to eat.   I was blessed to have connected with a few very knowledgeable people that helped me in the area of diet.  I'm always willing to help people that need some support and suggestions, so feel free to contact me if you need some support.     



-- First and Only Subcutaneous Biologic Treatment Administered Every Four Weeks Approved for Ulcerative Colitis

Thursday, February 14, 2013

#LDN as treatment- 4 #Fibromyalgia - Positive Results in Trial

Published in February 2013, study to determine the effectiveness of naltrexone in low doses for fibromyalgia has again displayed positive results as a good treatment option for this condition.  Low Dose Naltrexone showed significant reduction in baseline pain, improvement with general quality of life and also mood improvement.  

Abstract of study is below.


Low-dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels.



 2013 Feb;65(2):529-38. doi: 10.1002/art.37734.

Younger J, Noor N, McCue R, Mackey S.

Source

Stanford University School of Medicine, Palo Alto, California. jarred.younger@stanford.edu.

Abstract

OBJECTIVE:

To determine whether low dosages (4.5 mg/day) of naltrexone reduce fibromyalgia severity as compared with the nonspecific effects of placebo. In this replication and extension study of a previous clinical trial, we tested the impact of low-dose naltrexone on daily self-reported pain. Secondary outcomes included general satisfaction with life, positive mood, sleep quality, and fatigue.

METHODS:

Thirty-one women with fibromyalgia participated in the randomized, double-blind, placebo-controlled, counterbalanced, crossover study. During the active drug phase, participants received 4.5 mg of oral naltrexone daily. An intensive longitudinal design was used to measure daily levels of pain.

RESULTS:

When contrasting the condition end points, we observed a significantly greater reduction of baseline pain in those taking low-dose naltrexone than in those taking placebo (28.8% reduction versus 18.0% reduction; P = 0.016). Low-dose naltrexone was also associated with improved general satisfaction with life (P = 0.045) and with improved mood (P = 0.039), but not improved fatigue or sleep. Thirty-two percent of participants met the criteria for response (defined as a significant reduction in pain plus a significant reduction in either fatigue or sleep problems) during low-dose naltrexone therapy, as contrasted with an 11% response rate during placebo therapy (P = 0.05). Low-dose naltrexone was rated equally tolerable as placebo, and no serious side effects were reported.

CONCLUSION:

The preliminary evidence continues to show that low-dose naltrexone has a specific and clinically beneficial impact on fibromyalgia pain. The medication is widely available, inexpensive, safe, and well-tolerated. Parallel-group randomized controlled trials are needed to fully determine the efficacy of the medication.
Copyright © 2013 by the American College of Rheumatology.
PMID:
 
23359310
 
[PubMed - in process]

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Low-dose naltrexone for the treatment of fib... [Arthritis Rheum. 2013] - PubMed - NCBI:

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Friday, January 18, 2013

Uceris Approved for Active Ulcerative Colitis #UC #IBD

Uceris sounds just like a drug that has been around for a while, Entercort (spelling?).  It works the same exact way Uceris works; it's a form of a steroid and releases in the colon.  Wonder what the difference is?/


Uceris Approved for Active Ulcerative Colitis

Santarus announced that the FDA has approved Uceris (budesonide) extended-release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.
Uceris contains budesonide in a novel oral tablet formulation that utilizes proprietary MMX multi-matrix system technology, which is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Budesonide is a corticosteroid known to have localized anti-inflammatory effect.
Uceris will be available in 9mg extended-release tablets in 30-count bottles. Uceris is expected be available in March 2013.
For more information call (858) 314-5700 or visit www.santarus.com

Uceris Approved for Active Ulcerative Colitis - MPR:


http://www.drugs.com/newdrugs/santarus-receives-fda-approval-uceris-budesonide-induction-remission-patients-active-mild-moderate-3638.html


FDA Approves Uceris

Santarus Receives FDA Approval of Uceris (budesonide) for the Induction of Remission in Patients with Active, Mild to Moderate Ulcerative Colitis
SAN DIEGO--(BUSINESS WIRE)--Jan 15, 2013 - Santarus, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Uceris (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. The company expects to commence the commercial launch of Uceris in March 2013.
“The FDA approval of Uceris provides an important new therapeutic option to patients and physicians for the treatment of active, mild to moderate ulcerative colitis,” said William J. Sandborn, M.D., chief, division of Gastroenterology, director, University of California San Diego (UCSD) IBD Center and professor of clinical medicine, UCSD Health System. “Specifically, Uceris is indicated for use in the induction of remission of active disease, an acute phase of the disease often characterized by cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements.”Uceris contains budesonide, a corticosteroid, in a novel oral tablet formulation that utilizes proprietary MMX® multi-matrix system colonic delivery technology. The approved dosing regimen for adult patients is one 9 mg tablet taken orally once daily in the morning for up to 8 weeks. Uceris was developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A.
Gerald T. Proehl, president and CEO of Santarus, said, “We are pleased to provide a new option for patients to treat the active phase of mild to moderate ulcerative colitis. With the incremental revenue from Uceris and continued growth in our marketed products, we anticipate another robust year of solid financial results for Santarus in 2013. We expect total revenues of $320 million to $325 million, representing significant double-digit growth over our 2012 revenue guidance."

Important Safety Information About Uceris

Uceris is a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis under control. Uceris is taken once daily in the morning with or without food for up to 8 weeks.
  • Do not take Uceris if you are allergic to budesonide or any of the ingredients in Uceris.
  • Before you take Uceris, tell your doctor if you have liver problems, are planning to have surgery, have chickenpox or measles or have recently been near someone with chickenpox or measles, have or had a family history of diabetes, cataracts or glaucoma, have high blood pressure (hypertension), decreased bone mineral density (osteoporosis), stomach ulcers, any other medical condition, are pregnant or plan to become pregnant, or breastfeed or plan to breastfeed.
  • Tell your doctor about all the medications you take, including prescription and over-the-counter vitamins and herbal supplements. Uceris and other medicines may affect each other, causing side effects.
  • Do not eat grapefruit or drink grapefruit juice while taking Uceris because these can increase the level of Uceris in your blood.
  • Long-time use of Uceris can cause you to have too much glucocorticosteroid medicine in your blood (hypercorticism). Tell your doctor if you have any of the following signs and symptoms of hypercorticism: acne, bruise easily, rounding of your face (moon face), ankle swelling, thicker or more hair on your body and face, a fatty pad or hump between your shoulders (buffalo hump), or pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms.
  • When Uceris is taken for a long period of time, the adrenal glands do not make enough steroid hormones. Tell your doctor if you are under stress or have any symptoms of adrenal suppression during treatment with Uceris, including tiredness, weakness, nausea and vomiting, and low blood pressure.
  • Uceris weakens your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases such as chickenpox or measles while taking Uceris. Tell your doctor about any signs or symptoms of infection, including fever, pain, aches, chills, feeling tired, or nausea and vomiting.
  • If you take certain other corticosteroid medicines to treat allergies (e.g., eczema, rhinitis), switching to Uceris may cause your allergies to come back. Tell your doctor if any of your allergies become worse while taking Uceris.
  • The most common side effects with Uceris are headache, nausea, decreased blood cortisol levels, stomach-area pain, tiredness, stomach or intestinal gas, bloating, acne, urinary tract infection, joint pain, and constipation.
Uceris is available by prescription only. For additional information, talk to your healthcare provider and see the Full Prescribing Information including Patient Labeling.

Monday, May 28, 2012

Health Expert -Jake Wilson States Advantages of Taking Probiotics for: Acute diarrhea & more

The many benefits of taking probiotics regularly.  

Some Article Highlights:

"As a result from taking antibiotics, absorption of fatty acids and glucose are interrupted and osmotic diarrhea ensues along with the immune system’s efforts to flush out contaminants. With probiotics, the chance of suffering through the condition is lessened by 42%

 "the combination of multiple bacterial strains in probiotics have been guaranteed to lessen the duration of diarrhea as well as the frequency of defecation."
"Prolonged antibiotic treatment also makes folks susceptible to Clostridium difficile overgrowth – which is another major cause of digestive problems.
Introduction of Lactobacillus, for example, in the system is more than a welcome alternative to the usual protocols as it not only reduces the chance of antibiotic-associated diarrhea but also enhances the immune system and improves stool consistency"
I would recommend Metagenics for a trusted & high quality probiotic.  

 http://www.metagenics.com/

Wednesday, May 11, 2011

Abbott Labs -Just read 1st quarter global sales amount w/ Humira & almost puked!

Abbott's Humira is currently approved, either as a single therapy or in a combination, to treat rheumatoid and psoriatic arthritis in adults, and a type of juvenile arthritis affecting children. The drug is also approved to treat adults suffering from Crohn's disease, as well as severe chronic plaque psoriasis. Humira is a money spinner for Abbott, with first-quarter global sales improving 17.8 percent to $1.65 billion. Of this, U.S. sales grew 16.2 percent to $630 million.


In another article from RTTNews, Abbott Labs is working on getting Humira approved for Ulcerative Colitis, or UC for short.  The % of people that went into remission isn't very impressive.  It's significant, but barely.


According to the company, of the 248 patients treated with HUMIRA in the study, 16.5 percent achieved clinical remission compared to 9.3 percent on placebo at week 8. At week 52, 17.3 percent achieved clinical remission compared to 8.5 percent on placebo. These results were statistically significant compared to placebo.
HUMIRA is not approved for the treatment of UC. Abbott recently submitted applications to both the U.S. Food and Drug Administration and the European Medicines Agency seeking approval to market HUMIRA for the treatment of moderate to severe UC.

Saturday, May 07, 2011

A Short Article That Says A Lot About LDN


I like this short article because it covers the history of the drug LDN, how it started to get used for autoimmune diseases and why the FDA hasn't approved it for conditions other than drug addiction.  This article is from 2007 however, it's now 2011 and people still haven't heard about low dose naltrexone as an alternative treatment for many diseases.  I began doing research for SAFE and effective treatment for Crohn's Disease because I was on Remicade.  In my opinion, Remicade and other biologic drugs that weaken the immune system are not SAFE options.  Read the side-effect and safety indications for any of the biologics that are being used for many inflammatory diseases.  After reading this for yourself, you will understand why I consider this an unsafe treatment. Next, look up the side-effect and safety warnings for LDN/naltrexone.  
Now which one would you choose ?   

LDN - An Emerging Treatment - Article By Carl Frankel, Care2 Green Living contribution writer
If you’re one of the millions of people with auto-immune disease, there may be help for you. It’s a drug with a mouthful of a name—Low-Dosage Naltrexone, or LDN for short.
LDN is best known for its effect on multiple sclerosis. Thousands of people with MS are persuaded that it has halted the disease’s downward progression, and even reversed their symptoms. People with lupus, fibromyalgia, chronic fatigue syndrome, Crohn’s disease, and psoriasis also report benefits.
The good news doesn’t stop here. LDN is affordable—a bit over a dollar a day. Side effects——and many people don’t have them—are mild and short-term. It’s even FDA-approved, sort of. (It has “off-label” approval, meaning the FDA okayed it for a different purpose.)
The story of LDN is an intriguing saga of one man’s pioneering work, followed by a grass-roots, Internet-driven movement.
Naltrexone, without the “low-dosage” part, was developed by Dupont to treat drug addition, and approved in 1984 by the FDA for that purpose. The standard dosage was 50 milligrams, and it didn’t pan out as a treatment. Naltrexone blocks the opiate receptors in the brain. It works, in other words, by taking the fun out of taking opiates. The problem is, it takes the fun out of just about everything else, too. The result: People wouldn’t stay with the program.
Bernard Bihari, a Harvard-trained neurologist, began researching naltrexone and discovered something remarkable. When people took the drug in very low doses (3.0—4.5 milligrams instead of the standard 50 mg. dosage), it appeared to have a dramatic effect on auto-immune diseases. Bihari hypothesized that this essentially homeopathic dosage caused the body to manufacture more endorphins, which are centrally involved in supporting and regulating the immune system. He also came to believe it helped fight cancer and HIV.
Over the past 15 years or so, many thousands of people have taken LDN, to positive effect. The “anecdotal” evidence, so-called because it’s derived from stories, not studies, is overwhelmingly positive. It is also hugely persuasive, if you’re not the sort of person (your typical doctor, for instance) who requires clinical trials to be persuaded.
Where has the medical establishment been during this explosion of grassroots interest? Until recently, unmotivated and indifferent. Because the patent has expired and the drug is so inexpensive, there’s little money to be made from LDN, and therefore little reason to conduct clinical trials.
This can make it difficult to get a prescription for LDN. Because it hasn’t been clinically proven to be an effective auto-immune disease treatment, many doctors won’t prescribe it.
Recently, the medical establishment has started turning its attention to LDN, for a very simple reason: The anecdotal evidence is that overwhelming. Three national conferences on LDN have been held, and clinical trials have been launched in the United States and elsewhere. The first study to report results came out of Penn State University: “LDN therapy appears effective and safe in subjects with active Crohn’s disease.”
If you’re interested in learning more about LDN, a wealth of information is available at
www.ldninfo.org.
As for whether or not to try LDN, at the end of the day, there’s only one person who knows what’s right for you. And that’s you.
Carl Frankel is a journalist and author who has been writing about green business, green products, and integral living for the past 20 years.
More on Alternative Therapies (184 articles available)
More from Carl Frankel (12 articles available)


Read more: http://www.care2.com/greenliving/ldn-an-emerging-treatment.html#ixzz1LfORWCGV

Wednesday, May 04, 2011

Naltrexone - general info & other conditions it could possibly treat

So many people are clueless about this treatment... Thank you FDA, we love you too.
*Naltrexone is only FDA approved for the treatment of opiate/alcohol addiction in the US*  

Low doses of naltrexone can treat Crohn's, Colitis, MS, Cancer, AIDS & an array of other autoimmune diseases (this we know because the clinical trials say so & from personal experience ....  I'm feeling better and I've only been on it for 6 days!!!! YAYYYY)

This is just basic information about naltrexone.   Click on **Other Uses** and see the list of other conditions that Naltrexone can possibly treat.. I can't believe the list.  Autism to sexual dysfunction  Whaaaaaat?

http://en.wikipedia.org/wiki/Naltrexone
http://en.wikipedia.org/wiki/Naltrexone#Other_uses

 




Wednesday, April 27, 2011

Yuck = Biologic Drugs-Article states Humira causes permanent nerve damage


Abbott Labs Sued on Claim Humira Caused Lasting Nerve Damage


Abbott Laboratories (ABT) was sued on claims that its top-selling drug Humira caused permanent nerve damage in the feet of a Montana woman who took it for Crohn’s disease.
Two doctors who treated Kara Mae Pletan at the Mayo Clinic in 2008 said the nerve damage in her feet “was most likely due to Humira,” according to the lawsuit, which was filed today in state court in Chicago, near the company’s headquarters in Abbott ParkIllinois.
The complaint also alleges Abbott knew that Humira, which had 2010 worldwide sales of $6.5 billion, could cause peripheral neuropathy before it began marketing the drug to Crohn’s patients in 2007. Earlier this year, Abbott was sued by two arthritis sufferers in Texas andMassachusetts who claim Humira gave them cancer.
“Abbott has downplayed the risk of side effects, including the very real risk of permanent neuropathy,” Andy Vickery, Pletan’s lawyer, said in an e-mail.
Abbott initially sold Humira in 2003 as a treatment for rheumatoid arthritis. The U.S. Food and Drug Administration now approves Humira for the treatment of five additional autoimmune diseases, including Crohn’s.
Humira is expected to outsell Roche Holding AG (ROG)’s Avastin cancer medicine by 2016 to become the world’s most lucrative drug, according to a May 2010 forecast by research company EvaluatePharma.

Safety Data

“Humira has more than 12 years of clinical and safety data and best-in-class efficacy,” Adelle Infante, an Abbott spokeswoman, said in January, after the filing of the first lawsuit claiming Humira caused a Texas woman’s cancer. “The therapeutic risks associated with Humira are well known and documented in the prescribing label.”
Infante today declined to comment on the nerve-damage suit because Abbott hasn’t read the complaint.
Humira’s full package insert as of July 2004 warned that patients in clinical trials of similar types of drugs had developed more cancers than patients receiving other rheumatoid arthritis treatments. The class of drugs, known as tumor necrosis factor-blockers, prevent the body’s cancer-killing cells from working.
“The FDA has yet to focus in on the risk of neuropathy and other forms of neurological side effects, and Abbott has chosen to provide little if any information about these risks to either physicians or patients,” Pletan said in the complaint.

Issued Report

Doctors at Angers University in France issued a report in April 2006 suggesting that Humira could cause peripheral neuropathy, Pletan said in court papers.
“Abbott was actually aware of this article prior to the 2007 launch for Crohn’s,” she said.
In January, Gayathri Murthy, a Houston hospital worker, sued Abbott claiming she developed lymphoma while taking Humira for arthritis in 2005 and 2006. Earlier this month, a Massachusetts arthritis patient, Maureen Calisi, sued the company for allegedly causing her lymphoma after she took Humira from 2003 until 2008. Both cases are pending.
Both Murthy and Calisi are represented by Vickery, of Vickery, Waldner & Mallia LLP in Houston, who said he has “more than a dozen clients with legitimate legal claims involving Humira.”

Months of Injections

Pletan, 32, claims she developed small fiber peripheral neuropathy after receiving three months of Humira injections in 2008. The resulting “stabbing pains and hypersensitivity” in her feet forced her to give up outdoor activities and sell her family’s retail furniture store in Bozeman,Montana, when she could no longer work on her feet, she said in her complaint.
“The progression of the nerve damage seems to have stopped” after ceasing Humira injections, Pletan said in the filing. The nerve damage “appears to be permanent,” she said. Pletan is seeking both economic and punitive damages.
The case is Pletan v. Abbott Laboratories, 2011L004270, Circuit Court of Cook County, Illinois (Chicago).
To contact the reporters on this story: Laurel Brubaker Calkins in Houston atlaurel@calkins.us.com; Margaret Cronin Fisk in Southfield, Michigan, atmcfisk@bloomberg.net.
To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net