Most pages of my copy of Nuland's How We Die sport underlinings and check marks. On page 72, though, I drew a big question mark in the margin beside a paragraph that preceded another that earned a "great insight!"
The case of the FDA revoking approval of Avastin for the treatment of breast cancer is complicated by the urgency of the need for better therapies. We’re not talking about treatments to decrease the sniffles of the common head cold. At issue is a drug to help patients who are suffering -- and dying -- from metastatic breast cancer.
Now let's look at the players who influenced the FDA's decision to revoke approval of Avastin for breast cancer. The complex process requires a book-length manuscript to fully explain. Rather than abandon my effort, here are the bare bones:
In my last post I shared my response to a reader who was upset by the media reports of a new study. The commenter expressed ambivalence about discussing it with her physicians: "I don't know if it would be healthy or not to ask my doctors...if [knowing what we know today] I would have been spared this surgery."
On my recent post about clinical trials, commenter Steve Walker wrote, "The Phase III trial is being run primarily to satisfy the rigid, formulaic and in many cases scientifically obsolete requirements imposed by the FDA's Office of Oncology Drug Products for most cancer drugs...."
Recently, I've pointed out the clashes between business and ethical considerations and beween clinicians' obligations to their individual patients and to the method that leads to advances. What if researchers can find ways to satisfy both the science and today's patients?
Sunday's NYTimes ran an article tackling a complex ethical dilemma in cancer care: The witholding of treatment in clinical trials. Because I was treated in 3 clinical trials in the 1990s, the topic is close to my heart.
Patients wanting to learn about their illness used to search high and low for a few drops of patient-centered information. The dilemma for modern patients has become how to sort through the flood of information available on the Internet.
How did I go from rattled to relaxed in a matter of hours after learning about my risk of carotid disease due to radiation therapy I received 18 years ago? First, by putting the piece of information in perspective, as outlined in my last post. Second, by making a plan of action.
But then he explains that the new drug -- ipilimumab -- improves life expectancy from 6 months to 10 months. And it works well in only 20-30% of patients, the other 70-80% of patients showing no benefit at all. And it carries serious side effects, such as colitis and rheumatoid arthritis.
Your doctors evaluate your pain and conclude it is due to something benign (i.e., you don't have cancer, a broken bone or other health-threatening condition). Then they give you a prescription for a placebo. Should you sue these doctors? Or thank them?
In the May 2010 issue of Ladies Home Journal,Susan Crandall begins her article, "When Wendy Harpham, MD, learned she had non-Hodgkin's lymphoma 19 years ago, her first thought was for her kids. She was only 36, but as a doctor she knew the scary stats: Her life expectancy was only about seven years. ...But advances in medicine transformed her prognosis and her future. Harpham is a member of a small but growing contingent of cancer patients who live with metastatic or otherwise-incurable disease for years, even decades."