Monthly Archives: February 2008

ESAs: The Evidence Mounts They May Be Harmful

A research paper in today’s issue of the Journal of the American Medical Association provides unfortunately impressive evidence that erythropoiesis-stimulating agents, or ESAs, are in fact dangerous to the health of cancer patients.


 


The drugs, known by their trade names Procrit and Aranesp, have been the focus of intense scrutiny by patients, patient advocates, researchers, the press, politicians, the Centers for Medicare and Medicaid Services and others for much of the past year.


 


The current report, authored by a group of researchers from many well-regarded universities, shows that without a doubt ESAs lead to a much higher incidence of venous thromboembolism when patients treated with these drugs are compared to those who are not treated with ESAs.


 


The paper also reports that survival is shortened for cancer patients treated with ESAs, although the results are not quite as dramatic.


 


ESAs have been important drugs in the treatment of patients with cancer. 


 


They first came to market in the early 1990s.  For those of you who aren’t familiar with cancer treatment at that time, we had great concerns about the safety of the blood supply.  Transfusions will always have risks, but … Continue reading →

Avastin In Breast Cancer: The FDA’s Dilemma

The FDA’s decision late Friday afternoon to provide “accelerated approval” for the use of Avastin in the first line treatment of HER-2 negative metastatic breast cancer was the culmination of a lot of handwringing and head scratching on the part of many people.


 


From my vantage point, the FDA made the right decision in a difficult situation.  That said, this is not the end of this story.


 


I have previously written about Avastin and the decision of an FDA advisory panel several months ago to (closely) vote not to approve the drug for this indication.


 


That decision by the panel members had to be a difficult one.  Metastatic breast cancer is a disease that is treatable, but not considered curable.  Every time we have a new drug that may offer benefit to women in this circumstance, it is important that we make certain that we are providing an effective therapy that will indeed help those in need.


 


The Avastin situation is of interest for a number of reasons.


 


When determining if new cancer drugs are effective, the FDA generally wants to see evidence that the group treated with the drug lives … Continue reading →

A Paradox: Cancer Deaths Are Up And Rates Decline

Every year around this time the American Cancer Society publishes its annual “Cancer Facts and Figures.”  This year, the report is being released today, February 20th


 


You may not know the name of the publication, but you may well be familiar with its content.  This is the report that is so frequently quoted in the media as the source of a statement which is something to the effect, “According to the American Cancer Society, “x” number of people will be diagnosed with (type of cancer) in the United States in 200x, and “y” number of people will die from that disease.”


 


The reason this report is so important is that it provides us with an update in how we are doing in our nationwide fight against cancer.  It provides an estimate of the incidence and deaths of cancer in 2008, based on the best available information from years past.



This report also provides us an opportunity to get a sense of where we are headed in our efforts to eradicate cancer as a fatal disease.  And, each year, we select a particular topic to focus on which will provide us … Continue reading →

What Do The Warnings About Chantix Really Mean?

Last Friday the Food and Drug Administration (FDA) announced there is an increasing probability that the smoking cessation drug Chantix is associated with the onset of new, serious psychiatric symptoms.  That raises a number of questions that could impact the use of this effective medication.


 


I can’t say that I am surprised.


 


Chantix—also known by its generic name varenicline—was approved by the FDA in May 2006 to help smokers quit. 


 


Unlike other medications used to help people stop smoking (such as nicotine replacement products in the form of patches, gums and sprays, or an anti-depressant called Zyban–also known as Wellbutrin), Chantix works in a unique way by blocking nicotine receptors in the brain.


 


The initial research reports in the Journal of the American Medical Association indicated that Chantix was more effective in helping smokers quit when compared to placebos and Zyban.


 


When studied in over 1000 “generally healthy smokers” who took Chantix for the prescribed 12 week course, 21.9% of the people who used Chantix were still not smoking at one year compared to 16.1% of the participants who took Zyban and 8.4% of the people who used a placebo.


 Continue reading →