The Food and Drug Administration is reporting shortages of leucovorin calcium, used to enhance the effectiveness of 5-FU (fluorouracil) in treating colorectal cancer.  The reason the FDA gives for the shortage is “Manufacturing Delays.” Leucovorin is supplied by Teva Pharmaceuticals and Bedford Laboratories, and the FDA directs consumers to contact them for more information.

According to a bulletin from the American Society of Health System Pharmacists (ASHP), “Leucovorin calcium lyophilized powder is on back order and the company cannot estimate a release date.” In addition, ASHP has been told, “The manufacturers will not provide a reason for the shortage.” ASHP updated their information with personal communications with the manufacturers on December 8, 2008.

Calls from to the FDA, Teva, and Bedford from patient advocates on December 12 provided no new information about what was causing the problem or when it might be resolved.

The shortage not only affects thousands of colon and rectal cancer patients who are being treated with 5-FU and leucovorin, it impacts over one hundred clinical trials in the United States where leucovorin is part of treatment protocols.  Read the rest of this entry »

Robin Toner 1954-2008

Robin Toner, the first woman chief national political writer for the New York Times, died of colon cancer on December 12, 2008 at her home in Washington.  She was 54.

Toner covered five Presidential campaigns and numerous Congressional and state elections.  She also wrote extensively about health policy including covering the Clinton health care reform initiative. Read the rest of this entry »

Tina at 2008 Call-on Congress

C3 was dealt yet another blow in our fight against colorectal cancer. One of our advocates, Tina Kiser, passed away from this terrible disease over the weekend. I had the pleasure of meeting Tina at last year’s Call-On Congress. Her passion to end the pain and suffering felt by everyone touched by colorectal cancer was extremely visible in everything she did. Whether it was walking the halls of Congress or recruiting people to make phone calls during the Congressional Butt-In, Tina was determined to get things done.

Two of Tina’s fellow C3 advocates, Marilia Sardinha and Suzanne Lindley, remember their time with her:

Read the rest of this entry »

On November 11, 2008 the Food and Drug Commission issued an alert about the safe use of bowel cleansing products that contain oral sodium phosphate. The FDA is requiring that the manufacturers of prescription Visicol® and OsmoPrep® put Black Box warnings on the labels for these products.  In addition, the FDA intends to change labeling for over-the-counter oral sodium phosphate bowel preps including Fleet Phospho-Soda.

New FDA labeling for over-the-counter sodium phosphate products will say that they should not be used for bowel cleansing and will address their safe use as laxatives.

The alert follows more than 20 reports of acute phosphate nephropathy, a kidney injury that can cause permanent kidney damage, after the use of OsmoPrep.

Visicol, OsmoPrep and over-the-counter Fleet Phospho-soda are frequently used to clean the bowels in preparation for colonoscopy or other procedures. Read the rest of this entry »

Former Senator Tom Daschle (D-SD)

President Elect Barack Obama formally announced former Senator Tom Daschle as his pick for Secretary of Health and Human Services (HHS) on Thursday. Daschle is also expected to serve as the Director of the White House Office of Health Reform. Read the rest of this entry »