Editor’s note: After a diagnosis of Stage III rectal cancer in 2000, Deborah Kanter embarked on major life changes including earning a Masters Degree in Holistic Health Studies, and becoming active with C3. Last month she participated in her first Call-on Congress. During this advocacy experience she discovered some surprising connections with her Congressman and his staff.

“I’m from Paterson; I can handle anything,” Rep. Bill Pascrell, Jr. (D-NJ, 8th) informed the crowd of mostly seasoned politicos and health advocates at a March 21 question and answer breakfast. “I’m from Paterson; I can handle anything, including colorectal cancer,” I informed Pascrell, as I introduced myself. I followed with a 30 second summary of key funding and screening points. I trust he will remember; we are Paterson people–Great Falls, textiles, good bagels; that New Jersey toughness, that New Jersey heart.

As I surveyed the room prior to meeting Rep. Pascrell and trading advocacy concerns with others attending, I wondered if I would find my way among this group of seasoned politicos and advocates. This was my premier C3: Colorectal Cancer Coalition advocacy stint. Would I be heard among this group of well-versed advocates? Yes! I relied on knowledge, passion and commitment to this life important cause. How glad I was that Joe Arite, C3 Policy and Grassroots Manager, also attended this breakfast!

Prior to Rep. Pascrell’s arrival, I spoke with his assistant, Charla Penn-McManus, who listened and responded intently. Upon learning that I was from Montclair, she said, “You should meet our Chief of Staff who is also from Montclair.” Later, the Chief of Staff, Benjamin Rich, walked in. My “second favorite moment,” then intensified. Benjamin and my son used to tuba jam years ago when they were both in high school!

No, I did not remind Benjamin Rich about youthful tuba days; however, a new connection was forged. I did remind him about the need for increased funding for the National Institutes of Health and the National Cancer Institute and the boost to the Centers for Disease Control and Prevention. We compared the cost of a colonoscopy to a chemotherapy session. Our conversation made sense. He listened, I listened to his summary of Rep. Pascrell’s health efforts and added that if I need anything, to email or call. I will.

This experience solidified my commitment to advocacy. I found so many connections in one room and a new favorite moment to join the rest during this most exciting, energizing Call-on Congress. These moments will evolve into hours; I am ready for more!

Leaving small 6 to 9 millimeter polyps in place after screening CT-colonography and repeating  the test in three years will result in more deaths from colorectal cancer than removing them immediately during a follow-up colonoscopy.  In addition, significantly more colorectal cancers will develop during that wait.

While there is agreement that polyps 10 millimeters and larger found during CT colonography (so-called virtual colonoscopy) should be removed, it has been unclear what to do about smaller polyps.  One strategy is to remove them immediately during a regular colonoscopy.  Another suggestion is to leave them in place and repeat CT colonography in three years.

Researchers at Massachusetts General Hospital and Harvard Medical School built a computer model to predict outcomes for both strategies for small polyps found in average risk patients.  Values for the model were found in published literature and SEER (Surveillance Epidemiology and End Results) data.

The computer model predicted that an immediate colonoscopy and polyp removal would result in 14 deaths from colorectal cancer per 100,000 patients.  The wait and repeat strategy would result in 79 deaths per 100,000.

Removal of polyps immediately would mean 39 cancers for every 100,000 patients compared to 773 cancers if a repeat CT colonography was done after a three-year wait.

Chin Har’s team concluded:

Managing smaller polyps detected on a screening CTC with another CTC examination 3 years later likely will result in more deaths and cancers than immediate colonoscopy and polypectomy.

SOURCE: Har et. al. Clinical Gastroenterology and Hepatology,Volume 5, Issue 2, February 2007, Pages 237-244

Novartis has agreed with the FDA to a voluntary withdrawal of Zelnorm® from the market.  New information has shown an increased risk of serious cardiovascular events including heart attack, chest pain, and stroke in patients using Zelnorm.

After reviewing data from a pooled analysis of nearly 30 short-term randomized clinical trials comparing Zelnorm (tegaserod) to placebo, the FDA decided that its risks outweighed its benefits and asked Novartis to voluntarily withdraw the drug on March 30, 2007. 

Over 18,000 patients were involved in the trials, 11,000 on Zelnorm and 7,000 on placebo.  Although the risk for adverse cardiovascular events was small, it was significantly higher in those patients who were taking Zelnorm.

The FDA is telling patients and doctors:

Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.

Patients who are taking Zelnorm should seek emergency medical care right away if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a heart attack or stroke. 

Physicians who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate to their symptoms and need.

Zelnorm was approved by the FDA for women with constipation associated with irritable bowel syndrome (IBS).  Irritable bowel syndrome causes lower abdominal pain, cramps, bloating, and constipation or diarrhea.  Zelnorm was not appropriate for IBS-associated diarrhea, and there was no evidence that it was effective in men.

In 2004, the FDA warned about severe diarrhea, dehydration, and ischemic colitis associated with Zelnorm use and changed labeling to include warnings about its use in patients who already were experiencing diarrhea.  Changes to the patient information  told them to stop the use of Zelnorm and contact their doctors if they experienced worsening stomach pain, rectal bleeding, or bloody diarrhea — all symptoms of ischemic colitis.

The FDA will work with Novartis to allow access to Zelnorm as an investigational drug in cases where there is no other option for treating IBS with constipation and where the benefits may outweigh the risks.

More information:

• FDA Public Health Advisory on Zelnorm
• More questions and answers about the Zelnorm withdrawal from the FDA.
• FDA news release.
• Novartis press release
• 2004 questions and answers regarding diarrhea and ischemic colitis.

German surgeons reviewed all patients in a Berlin hospital who had a second surgery to remove colon or rectal cancer that had spread to their livers (hepatectomy).  Of 811 patients who had liver resection, 94 had an additional surgery when cancer recurred again in their livers.

Researchers found that surgical complications were similar to those in initial resections.

In addition, outcomes were good.  Nearly 25 percent were still alive after ten years. 38 percent survived 5 years and 89 percent of patients lived at least one year after the surgery.

A. Thelen and colleagues from the Charité Universitaetsmedizin Berlin concluded:

Repeat hepatectomy is a safe and effective treatment for recurrent liver metastases from colorectal cancer. Perioperative risk and long-term survival were similar when compared to the results obtained during the initial resection. Achieving a curative resection is the most relevant prognostic factor for a favourable prognosis after repeat liver resection.

SOURCE: Thelen et. al., European Journal of Surgical Oncology, Volume 33, Issue 3, April 2007, Pages 324-328.

Schering-Plough has made their polyethylene glycol (PEG) laxative Miralax® available over-the-counter in the same strength as the original prescription version.  Taken once a day, Miralax works by drawing water into the bowel.

A 2005 review of medical literature found good evidence to support the use of PEG laxatives to relieve constipation, assigning a Grade A. The only other agent with a Grade A rating, tegaserod or Zelnorm® has recently been removed from the market.  Grade B or moderate evidence was found for psyllium, and lactulose.  The reviewers found very little data on the use of commonly used laxatives including milk of magnesia, senna, bisacodyl, and stool softeners.

Writing in the American Journal of Gastroenterology, Ramkumar and Rao concluded,

There is good evidence to support the use of PEG, tegaserod, lactulose, and psyllium. Surprisingly, there is a paucity of trials for many commonly used agents. These aspects should be considered when designing trials comparing new agents with traditional therapies because their use may not be well validated.

Cancer patients often face constipation from chemotherapy and from the need for opiates to treat pain.