AMA Morning Rounds: FDA approves Genzyme's Lumizyme to treat patients with Pompe disease

The AP (5/26) reports that the Food and Drug Administration "approved Genzyme's drug to treat a muscle development disease." The drug, called Lumizyme (alglucosidase alfa), has just been approved to treat patients with Pompe disease in the United States and is currently manufactured in Belgium, where it is known as Myozyme.

The Boston Globe (5/26, Weisman) reports, "The decision represents the most important US drug approval for the Cambridge biotechnology company since 2003, when regulators signed off on Fabrazyme [agalsidase beta], a treatment for Fabry disease. Genzyme hopes Lumizyme will become a blockbuster, with worldwide sales of at least $1 billion annually."

The Boston Herald (5/26, McConville) reports, "The Cambridge biotechnology company said the drug will be sold in a box that warns users of potentially life-threatening anaphylactic reactions, severe allergic reactions and immune-mediated reactions." According to the company, it "will only give the drug to patients who are eight or older and enrolled in a risk mitigation program."

Potential ALS Drug Fails in Study

The AP (5/18) reports, "Teva Pharmaceutical Industries Ltd. said Monday its potential Lou Gehrig's disease treatment," talampanel, "failed to meet a key goal in a midstage study." The drug failed to meet its effectiveness goal in a study of 559 patients, although it did meet its safety goals.

Your voice needed in SGR survey

Please take a short survey designed by the AMA to determine how threatened cuts to Medicare physician payments and instability in the Medicare program are affecting physician practices. The survey will be open through close of business May 21, and results will be used in advocacy efforts to reform Medicare's current physician payment formula.

AMA Morning Rounds: Physicians using novel procedures for pain management.

Laura Landro writes in the Wall Street Journal (5/11) The Informed Patient column that peripheral-nerve stimulation, a procedure which allows a physician to implant a tiny, battery-operated generator, is one of a growing number of treatments for people who endure chronic pain, and who have been unable to find relief from drugs, physical therapy, or even acupuncture. The procedures typically cost between $15,000 and $50,000. Data show that about 76 million Americans suffer from chronic pain. Notably, the CDC has said that over eight million Americans use pain management drugs.

AMA Morning Rounds: Several medical groups say new financial regulations aimed at Wall Street are too broad

The Hill (5/3, Brush) "On the Money" blog reported that several "of the nation's largest healthcare associations," including the American Medical Association, "are warning Congress that they would fall under sweeping new financial regulations aimed at Wall Street." The association, in a letter, "said the scope and reach of a new consumer financial protection office are too broad and that they would face new regulations designed for banks and other financial companies."