Fight Colorectal Cancer

The FDA has informed companies that manufacture or distribute trimethobenzamide suppositories for relief of nausea to stop making and marketing them.  It has also withdrawn the New Drug Application (NDA) for Tigan suppositories originally granted in the 1970′s.

FDA has found no evidence that the trimethobenzamide containing suppositories are effective. 

The suppositories are currently on the market under such names as Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz.

The ruling does not affect oral capsules or injectable drugs containing trimethobenzamide, which have been FDA approved.

The Federal Register Notice published on April 7, 2007 completes a long process involving trimethobenzamide suppositories which began in 1979 when the FDA found that there was no evidence for their effectiveness treating nausea and vomiting in either adults or children.  At that time one of the companies holding an NDA for the suppositories requested a hearing.  Over the years, manufacturing companies were acquired by others and the hearing issue was not resolved, nor was additional information on effectiveness received.

At this point, the FDA has withdrawn the NDA and told any company that is marketing trimethobenzamide suppositories to stop doing so because there is no evidence that they are effective and, therefore, not FDA approved.  The Federal Register Notice applies to “any drug product that is identical, related, or similar to Tigan Suppositories and is not the subject of an approved NDA.”

The FDA tells consumers who have purchased or are using the suppositories to discuss the issue with their health care provider.

People with inherited familial adenomatous polyposis (FAP) develop hundreds of polyps in their colons and, without intervention, one hundred percent of them will eventually develop colon or rectal cancer.  In addition to colon cancer, they are at risk for cancers and benign tumors outside the intestinal tract including thyroid cancer.

In an attempt to find out how common thyroid cancer was among FAP patients, researchers at Massachusetts General Hospital reviewed charts of over 50 patients who had been diagnosed with FAP at that hospital. Six women (12%) also had thyroid cancer.  Their cancers were found at an average age of 33 with an average tumor size of 12 millimeters.

However, all had additional malignant spots in their thyroids smaller than 9 millimeters, and none were evident on ultrasound examination.

Twenty-two (79 percent) of 28 patients who had screening ultrasound had small nodules in their thyroids, almost all had several.  Two screened patients had thyroid cancer.

Maite Herraiz from the Thyroid Unit at Massachusetts General Hospital and the research team write in the Journal of Clinical Gastroenterology and Hepatology:

The 12% prevalence of thyroid cancer in this series of FAP patients is significantly higher than in previous reports. Among patients undergoing screening ultrasound, 7% had thyroid cancer. Nodular thyroid disease is very common in FAP. Because small nodules (<9 mm) might also be malignant, close follow-up with ultrasound and fine-needle aspiration might be warranted.

Familial adenomatous polyposis or FAP is inherited directly from parent to child.  It is caused by a mutation in the APC tumor suppressor gene allowing cells to grow unchecked.  FAP patients develop hundreds and sometimes thousands of small precancerous polyps in the intestinal tract, usually at an early age.  Not only are these individuals at inevitable risk for colorectal cancer, they also risk other cancers.

Children and teens whose parents have FAP should be tested early for the gene and watched carefully for the polyps and cancers.  Usually their colons are removed in adolescence or early adulthood, but they remain at risk for cancers outside of the colon and need careful follow-up.

SOURCE:  Herraiz et. al., Clinical Gastroenterology and Hepatology, Volume 5, Issue 3, March 2007, Pages 367-374.  

Eddie Leigh woke up in his bathroom in a pool of blood, not knowing why he had passed out or what was causing his pain.  His two and a half year struggle to find the reason for abdominal pain, nausea, fatigue and severe rectal bleeding is explored on Mystery Diagnosis on the Discovery Health Channel.

Eddie is a colon cancer survivor and motivational speaker who uses humor to raise awareness of colorectal cancer.  He speaks regularly to the public as part of the Trauma to Triumph tour and writes an e-newsletter for people living with cancer.  His colon cancer was diagnosed in 1999 and today he is healthy and cancer-free.

He shared his story with Katie Couric on the Today Show and has been interviewed on MSNBC. The Mystery Diagnosis program is a reenactment of his experiences.

• Mystery Diagnosis
• Discovery Health Channel
• Monday, April 9, 2007
• 10 p.m. (Eastern)
• Repeats:  April 15 at 6 p.m. and April 29 and 8:00 p.m. and 11:00 p.m.

Eddie writes,

I am working hard to raise awareness of colon cancer. When I had the rectal bleeding, I never thought of colon cancer. That is why we must get the word out about colon cancer, so people can take charge of their healthcare. We have to talk about this disease that no wants to talk about!

Colorectal Cancer Prevention Fund Part of California Tax Check-Off Program

Governor Arnold Schwarzenegger declared April 5 as the first annual Checkoff California Day. Checkoff California is a unique collaboration of 12 funds representing a wide range of causes that have come together to raise awareness and giving through California’s voluntary tax check-off program that appears on the state’s tax form.

One of the 12 funds is the California Colorectal Cancer Prevention Fund (CCCP Fund). Money from this fund goes towards financing research, prevention, and educational programs in the community targeting individuals and families. Funds also assist in providing early screening for the detection of colon and rectal cancer.

Click here for more information about California’s Tax Check-off Program.

Click here for a message from Gov. Schwarzenegger about Checkoff California Day.

Click here for a press release about the bill which established the CCCP Fund.

New Hampshire Considers Funding Colorectal Cancer Detection and Screening Programs

The New Hampshire General Court (the state legislature) is considering a bill (SB 213) which would establish a comprehensive cancer plan fund as well as a board to oversee the fund. The bill proposes to appropriate over $4 million for the fiscal years 2008 to 2011 towards a variety of cancer-related programs. Early detection and screening programs for colorectal cancer would receive $710,000.

A comprehensive cancer plan oversight board would be established to oversee the Department of Health and Human Services’ allocation of moneys from the fund. The bill requires two seats be filled by members of the public who are cancer survivors appointed by the American Cancer Society. This is an opportunity for colon and rectal cancer survivors to get a seat at the table.

The bill is scheduled for a Senate floor vote on April 12. There is no House action as of this writing. Go here to check the current status of the bill. If you are a resident of New Hampshire contact your state Senator and Representative and urge them to vote for SB 213.

Can alpha-lipoic acid (ALA) prevent peripheral neuropathy caused by cisplatin or oxaliplatin?  

People with colon and rectal cancer are often treated with oxaliplatin, and tingling, numbness, and pain in hands and feet associated with it can seriously interfere with being able to complete treatment.  While most peripheral neuropathy caused by oxaliplatin eases after treatment ends, it can continue up to 18 months.  In some patients it remains indefinitely.

Alpha-lipoic acid has been effective in treating peripheral neuropathy caused by diabetes.  It is an antioxidant, available as a nutritional supplement.

Led by Dr. Ying Guo, from M.D. Anderson Cancer Center in Houston. a randomized Phase III clinical trial will study the potential for alpha-lipoic acid to prevent chemotherapy caused peripheral neuropathy or reduce its severity.

Patients who are scheduled to receive either cisplatin or oxaliplatin chemotherapy regimens are eligible for the trial if they do not already have symptoms of peripheral neuropathy.

They will be randomized to take:

• Oral ALA three times a day for at least 24 weeks unless there is unacceptable toxicity.
• A placebo on the same schedule.

The study is double-blinded — neither patients nor their doctors will know if they are getting ALA or placebo.

The clinical trial will be conducted in centers across the United States.  Contact information is available on the NCI Clinical Trials website or by calling 1-800-4-CANCER, the NCI Cancer Information Service.

The trial is featured in the April 3rd NCI Bulletin.