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 Park, Illinois.

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

BOSWLLIA Herb Reduces Inflammation - Helps Crohn's,arthritis, colitis, more....

Here's the Article....Boswellia Reduces Inflammation
The ancient herb boswellia (Boswellia serrata) has been used for thousands of years to treat conditions that, in recent years, have been found to be caused by inflammation. Originating in Africa, China, and the Middle East, boswellia herbal extract is derived from the sappy resin of the boswellia tree. In the 1970s, German scientists discovered that boswellia produces therapeutic effects similar to those of the non-steroidal anti-inflammatory (NSAID) compounds ibuprofen and aspirin. Unlike boswellia, however, NSAIDs work by inhibiting the cyclooxygenase-2 (COX-2) enzymes. Unfortunately, medications that inhibit COX-2 often inhibit COX-1, which is needed to maintain a healthy stomach lining and common side effects include gastrointestinal bleeding.
Boswellia differs from the NSAIDs in its mode of action. Boswellia has been shown to reduce inflammation in both osteoarthritis and rheumatoid arthritis, inflammatory bowel disease, and other autoimmune conditions by blocking the lethal pro-inflammatory enzyme 5-lipoxygenase (5-LOX). A number of immune system chemicals released during the inflammatory response contribute to the chronic inflammation seen in atherosclerosis, osteoarthritis and certain autoimmune diseases. Blocking these pro-inflammatory chemicals reduces symptoms of inflammation and helps taper the autoimmune mechanism.

The Actions of Boswellia
Although the benefits of boswellia are similar to those of the non-steroidal anti-inflammatory drugs, boswellia works by blocking 5-LOX, which is the first enzyme released in the metabolic pathway leading to the synthesis of the immune system cytokines known as leukotrienes. Leukotrienes are harmful inflammatory substances thought to directly influence the disease process in a number of different disorders, including rheumatoid arthritis, cancer, and asthma.
The active ingredients of boswellia, the boswellic acids, decrease the activity of another pro-inflammatory enzyme known as human leukocyte elastase (HLE). HLE and leukotriene levels are increased in many inflammatory diseases and allergic reactions. To date, boswellia is the only substance known to reduce levels of both HLE and leukotrienes. In 2005, researchers found that boswellia works in part by altering the expression of the cytokine tumor necrosis factor alpha (TNF-α), another integral component in inflammation. An excess of TNF-α promotes chronic inflammation. Applying boswellia to cells has been shown to decrease the TNF-α-induced expression of cell adhesion and matrix metalloproteinase proteins, which are biochemicals related to endothelial dysfunction, cancer metastasis (spreading), arthritis, and other disease processes.

Benefits in Arthritis and Crohn's Disease
Researchers have found that boswellia helps prevent the deterioration of cartilage and joint tissue. This suggests that boswellia may relieve symptoms in arthritis by inhibiting the breakdown of connective tissues that is caused by tumor necrosis factor-alpha-induced expression of matrix metalloproteinase enzymes. Studies in both humans and dogs show after as little as two weeks of boswellia therapy include reduced pain, stiffness, and lameness.
In patients with rheumatoid arthritis and Crohn's disease, boswellia can help reduce the immune cells that promote inflammation while increasing the number of immune cells that inhibit inflammation (anti-inflammatory cells). In studies of patients with inflammatory bowel disease, ulcerative colitis and Crohn's disease boswellia reduced gastrointestinal inflammation and tissue damage.

http://www.suite101.com/blog/daisyelaine/boswellia_reduces_inflammation