YourLawyer.com® 1-800-LAW-INFO (1-800-529-4636)
Group Calls For Study Of Arthritis Drugs
Jul 1, 2009 | Parker Waichman Alonso LLP
Arthritis and other autoimmune medications have made recent headlines over a variety of issues including links to serious opportunistic fungal infections and cancer. Now, as part of President Barack Obama’s health care overhaul, a review of arthritis medications manufactured by Wyeth, Abbott Laboratories, and Johnson & Johnson (J&J) might warrant some additional scrutiny, reports Bloomberg.com.
Recently, we reported that federal regulators ordered the makers of Humira, Cimzia, Enbrel, and Remicade to strengthen the existing warnings about opportunistic fungal infections linked to the drugs. At least 45 people are known to have died from such infections. The U.S. Food & Drug Administration (FDA) ordered the new labeling under authority it was granted with the passage of its Amendments Act of 2007.
Drugs used to treat autoimmune disorders were also under investigation by federal regulators amid concerns they might be linked to cancer in children and young people. The drugs are known as tumor necrosis factor (TNF) blockers, and are used to treat various forms of arthritis including juvenile idiopathic arthritis and Crohn’s disease. Enbrel, marketed by Wyeth and Amgen and Remicade sold by Schering-Plougshare among these drugs which are TNF blockers and which impede the action of a substance made by the body’s immune system called TNF. People with an autoimmune disease, such as rheumatoid arthritis, have too much TNF in their bodies.
Arthritis drugs generated nearly $17 billion in 2008 for drug giants Amgen, Wyeth, Abbott, and J&J, noted Bloomberg. Advisors external to the Department of Health and Human Services (HHS) said studies should compare drug efficacy for Remicade (J&J) and Enbrel (Wyeth and Amgen), specifically, said Bloomberg.
As part of the health system overhaul, President Obama has slated a little over $1 billion under the U.S. economic-stimulus plan to study medical treatment efficacy, said Bloomberg. According to a report just issued by the Institute of Medicine—an arm of the National Academy of Sciences—it recommends how approximately $400 million of the allocation to HHS should be used, according to Bloomberg. Last year, the U.S. spent $2.4 trillion on health care, which is greater than any other industrialized nation, said Bloomberg, noting that the U.S. also has the highest rates of both chronic disease and infant mortality, citing the report.
It has long been known that people taking TNF blockers run a risk of developing opportunistic infections, and the prescribing information for the drugs has included this information. But the FDA says that current warnings are inadequate. The labeling order came after the FDA reviewed 240 reports of histoplasmosis; an infection caused by the fungus Histoplasma capsulatum, in patients treated with Enbrel, Humira, or Remicade. In at least 21 cases, health care professionals did not initially recognize histoplasmosis, antifungal treatment was delayed, and 12 patients died.
The FDA also reviewed TNF blockers over a possible link to cancer. Last June, the agency said it was investigating about 30 reports of leukemia, lymphoma, and other cancers in children and young adults. Approximately half of the reports were lymphomas, cancer of the immune system cells, which were both Hodgkin’s and non-Hodgkin’s based. In April, the FDA had Amgen and Wyeth include a new black box warning on the Enbrel label stating that the drug has been associated with serious infections, including tuberculosis (TB) in some patients. The Enbrel black box warning was prompted by global studies of over 20,000 patients taking Enbrel, in which TB was observed in about 200 people.
