July, 2007

Subcommittee Allocates FY08 Funds to FDA

Yesterday the House of Representatives’ Agriculture Appropriations
Subcommittee marked up its Fiscal Year 2008 Appropriations bill. The appropriations bill allocates funds to the Food and Drug Administration. Chairwoman Rosa DeLauro (D-CT) stated that she recognized there is a resource problem at the FDA and made a commitment to multi-year funding.

The FDA is funded at $1.7 billion, $121.5 million (7.7%) above Fiscal Year 2007 and $55 million (3.4%) above the President’s budget request.

Though not as high as hoped for, this is the best FDA budget in recent years.

Posted by Joe Arite on July 13th, 2007
Posted in: Policy & Advocacy News | No Comments »

NCI wants to interview women caring for people with cancer

The National Cancer Institute and the George Washington School of Public Health want to talk to women who are caring for a family member or friend with cancer. They want to learn more about the caregiving experiences and how caregivers cope.

The study wants to reach

Women
Between the ages of 31 and 80
Currently providing care for someone over the age of 20 with cancer, OR
Provided care for someone over the age of 20 with cancer at end-of-life within the last year

Study participation involves a 15-20 minute telephone interview. Some eligible caregivers will be asked to provide additional information about their experience during a follow-up 45-60 minute phone call.

To participate call

1-888-249-0029
Monday to Friday, 9am-5pm EDT

Posted by Kate Murphy on July 11th, 2007
Posted in: Research & Treatment News | 1 Comment »

FDA rejects health claims that tomatoes and lycopene reduce cancer risk

The United States Food and Drug Administration has refused to allow health claims that tomatoes or lycopene reduce the risk of getting cancer. For such claims to appear on the labels of food products or dietary supplements, the FDA must approve them before they are marketed.

According to a review in the Journal of the National Cancer Institute, the FDA found

No credible evidence that there was an association between lycopene intake and a reduced risk of prostate, lung,colorectal, gastric, breast, ovarian, endometrial, or pancreaticcancer.
No credible evidence for an associationbetween tomato consumption and a reduced risk of lung, colorectal,breast, cervical, or endometrial cancer
Verylimited evidence to support an association between tomato consumptionand reduced risks of prostate, ovarian, gastric, and pancreaticcancers.

In 2004 the FDA received two petitions for qualified health claims supporting the association between tomatoes, lycopene, and the risk of certain cancers.

In an accompanying editorial, Paul M. Coates from the Office of Dietary Supplements at the National Institutes of Health points out the difficulties of finding strong evidence to support tomato and lycopene claims. Many studies were preclinical, small, or based on observation. However, he defends the importance of clear and transparent evidence-based reviews and points out that such reviews can be updated if new information becomes available.

A second editorial writer, Edward Giovannucci, from the Department of Nutrition at the Harvard School of Public Health points out that studies supporting an association between tomato sauce, lycopene, and prostate cancer were done before PSA testing became common in the United States. More recent studies don’t agree. However, he believes that there may be a connection between more advanced prostate cancer and tomatoes that should be studied further, along with possible genetic associations and combinations of tomatoes, lycopene and other antioxidants.

More information is available in a JCNI press release.

SOURCE: Kavanaugh et. al, Journal of the National Cancer Institute, advance access, July 10, 2007.

Technorati tags: lycopene, colorectal cancer risk

Posted by Kate Murphy on July 11th, 2007
Posted in: Research & Treatment News | No Comments »

Weighing complications and survival in treating pelvic recurrences of rectal cancer

Even after successful surgery to remove rectal cancer, pelvic recurrences can happen. Surgery to remove the cancer offers a possibility of cure, but also has risks.

Surgical oncologists at Fox Chase Cancer Center in Philadelphia retrospectively reviewed surgeries to remove pelvic recurrences after rectal cancer surgery from 1988 through 2003 where the goal was curing the cancer.

Studying outcomes for 90 patients, they found

4 (4.4%) died during surgery
53 percent had surgical complications
5-year survival rate was 40%
51 of 86 patients had another recurrence: 15 locally, 16 to distant organs, and 20 both locally and distant

Carcinoembryonic antigen level (CEA) before surgery and clear surgical margins helped predict successful treatment.

Writing in the Annals of Surgical Oncology, Leonard B. Henry, MD, concluded,

The resection of pelvic recurrences after colorectalsurgery for cancer can be performed with low mortality and goodlong-term outcome; however, morbidity from such procedures ishigh. Low preoperative carcinoembryonic antigen and negativemargin of resection predict improved survival.

SOURCE: Henry et. al. Annals of Surgical Oncology, Volume 14, Issue 7, July 2007.

Technorati tags: rectal cancer, surgical resection, recurrence

Posted by Kate Murphy on July 9th, 2007
Posted in: Research & Treatment News | No Comments »

Anti-cancer virus shows early promise for colorectal cancer

Early information shows that a genetically engineered virus is safe and shrinks colorectal cancer tumors. The specially modified version of the herpes simplex virus is designed to attack and destroy cancer cells while leaving healthy tissue unaffected.

Once inside the cancer cell, the virus begins to divide and grow killing the cell and shrinking the tumor.

Dr. Axel Mescheder, from the Munich-based biotech company MediGene, presented safety information and a patient case study at the ESMO Conference in Lugano, Switzerland (ECLU). Describing the virus, called NV1020, Dr. Mescheder said,

It doesn’t replicate in normal, healthy cells, so our hope is that it will help fight cancers without causing side-effects in the rest of the body.

In the current study, the scientists are testing the treatment in patients with colorectal cancer that have not responded to chemotherapy and where the cancer has spread to the liver. We are hoping to extend overall survival.

Led by Dr. Tony Reid, the Phase I and II clinical trial is underway at seven cancer centers in the United States. Eligible patients include those who have

colorectal cancer that has spread to the liver
the liver as the major metastatic site
progressed on standard chemotherapies

In his poster presentation at ECLU, Dr. Mescheder described a patient in the trial who had extensive colorectal cancer tumors in his liver and several tumors in the lungs. Six months after treatment, the liver metastases had nearly disappeared. The patient lived for 12 months.

More information about the trial is available from:

MediGene Incorporated