An interesting article came out this week at the San Diego Union-Tribune by Cheryl Clark discussing the new advisory regarding ovarian cancer symptoms. This advisory was issued in June from the Gynecologic Cancer Foundation, the Society of Gynecologic Oncologists and the American Cancer Society. The advisory lists four symptoms as possible signs of ovarian cancer: bloating, pelvic or abdominal pain, frequent or difficult urination, and feeling full quickly or having difficulty eating.

Clark addresses physician reaction to this advisory, which is varied. Some doctors believe that the symptoms are vague and usually harmless and this advisory may cause overtesting or unnecessary anxiety. For example, Dr. Philip Young of Vista, CA said, "This isn't going to save any lives because the symptoms are far too vague." In addition, he and other physicians in the article note that even if these symptoms are reported, the disease is probably in an advanced stage at that point anyway.

Dr. Barbara Goff, a gynecologic oncologist at the University of Washington, who helped write the advisory, disagrees.

The Human Papillomaviruses (HPV) vaccine called Gardasil can protect from the infection of four types of the HPV virus. Two of these types cause up to 70 percent of all cases of cervical cancer.

Recommendations were released by the Advisory Committee on Immunization Practices (ACIP) regarding the use of Gardasil. The FDA approved Gardasil in June 2006.

The role of ACIP is to advise the Director of the Centers for Disease Control and Prevention (CDC) and the Secretary of the Department of Health and Human Services (HHS) about vaccine usage and vaccine-preventable diseases.

The recommendations published by the ACIP:

• Recommended age for routine vaccination of girls is 11-12 years.
• The vaccine can be given to girls as young as 9 years.
• Catch-up vaccination is recommended for girls and women between the ages of 13 and 26 years who were not vaccinated previously or who did not complete the full vaccine series (the vaccine is administered in three separate doses).
• Routine cervical cancer screening remains important following vaccination.

The ACIP's recommendations can influence policy and practice, but are not directly linked with school and daycare entry laws. These laws are made by individual states.

Reuters has just issued an update on Eli Lilly's announcement that the U.S. Food and Drug Administration, FDA, approved the use of Gemzar in the treatment of recurrent ovarian cancer, questioning why the company omitted information that the FDA approval goes against the advice of an FDA advisory panel earlier this year that strongly recommended against approval of the drug for this use.

The FDA approved use of Gemzar in combination with carboplatin, in chemotherapy treatment for women with advanced ovarian cancer that has relapsed at least six months after initial therapy. The reason the FDA advisory panel voted against the approval of the use of Gemzar in combination with carboplatin, were due to questions raised about Lilly's trial data and the way the company conducted the 356-person clinical study. The panel was concerned that patients in the late-stage clinical trial failed to survive longer than those taking carboplatin alone. The FDA went ahead and approved it after the drug company provided additional information.

What needs to be made clear is that Gemzar does not seem to prolong the life of women with recurrent ovarian cancer, and the drug company is only stating that Gemzar provides longer progression-free survival than patients taking carboplatin alone. Progression-free survival measures the time before the disease recurs or worsens.

According to Reuters, when a spokesperson for Lilly was asked why they did not mention in its release that the FDA advisory panel had voted against the approval of Gemzar, or the drug's failure to prolong life, he said, "I'm not sure that needed to be the focus."