Dr. Len's Cancer Blog

Now the committee is getting into the finer details as to how ESAs should be used, and what changes may have to be made to the FDA label regarding serious risks.

The next question in front of the committee is whether or not ESAs should be limited only to patients with small cell lung cancer, which is the only cancer where there is proof that the drug doesn't have serious adverse effects.

And the vote is...

And now we get to the meat of the matter at today’s hearings on the safety and effectiveness of ESAs: the opportunity for the committee to weigh in on the issue as to whether or not ESAs should be removed from the market for treating cancer treatment-related anemia (CTA).

Over the past number of years, medicine has tried to develop more evidence and science based rationales for the treatments we recommend.

The data currently being presented at the FDA Oncologic Drug Advisory Committee hearing today suggests that when it comes to ESAs (see previous blog), we still have a way to go in developing the evidence of their safety and risks.  The testimony currently being presented by the FDA representative shows genuine concern that when the evidence is carefully examined, the outcomes may not be what we would have expected

As I write this I am sitting in a meeting room in a hotel in Gaithersburg, Maryland attending a hearing in front of the FDA’s Oncologic Drugs Advisory Committee.   The purpose of the meeting is to review the data about the safety and effectiveness of drugs called ESAs, or erythropoiesis-stimulating agents.  You may know the drugs by their trade names, Procrit and Aranesp.

In plain English, these are drugs that have been used since 1993 to reduce the need for transfusions in patients on active cancer chemotherapy (there are other uses in other diseases but these are not the focus of today’s meeting).

What makes today so important is that the FDA has made one of its recommendations removal of these drugs from the market in the United States.

Today, the American Cancer Society released its latest recommendations for the prevention and early detection of colorectal cancer. 

The published guidelines offer a detailed roadmap on what works in colorectal cancer screening.  They include the same approaches that have been recommended in the past—including testing the stool for blood, sigmoidoscopy, colonoscopy and barium enema—and add two new approaches to the “recommended list” with the addition of CT colonography and stool DNA testing.

The experts who analyzed the data and made these recommendations made an important new distinction about tests used to screen for CRC by sorting the available screening tests into two categories: tests that are primarily used to detect colorectal cancer (CRC), and tests that have the potential to prevent colorectal cancer. 

They also indicated their preference was for tests that prevent this disease.

An article in today’s Journal of the American Medical Association (JAMA) is bound to add more confusion to the questions surrounding the impact of hormone replacement therapy (HRT) on the risk and incidence of breast cancer in post-menopausal women.

I have written several blogs previously on this topic, most of them discussing the reasoning behind the sudden and immediate drop in the incidence of breast cancer that was noted when the Women’s Health Initiative (WHI) study was discontinued in 2002.

Unlike previously published studies which showed a dramatic reduction in breast cancer incidence after the study was stopped and the use of post-menopausal HRT declined, the evidence in this report doesn't come to the same conclusion.  But, unfortunately, it also doesn't clarify the situation.