October 23rd, 2011 by GarySchwitzer in Opinion
No Comments »
On the NPR Shots blog, Scott Hensley addresses, “Avastin For Breast Cancer: Hope Versus False Hope.” Excerpt:
Any day now FDA Commissioner Margaret Hamburg is expected to make a final decision on Avastin’s fate. Women who said Avastin helped their breast cancer were out in force at a June hearing of an appeal of FDA’s proposal. At this point, it would be a big surprise if the agency let the approval, granted on an accelerated basis back in 2008, stand.
Now, one of the cancer specialists on the expert panel, which Read more »
*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*
October 19th, 2011 by AndrewSchorr in Health Policy, Interviews
No Comments »
If you’ve read my blogs for a while, or look up some past blogs, you’ll see I have been frustrated at times with the FDA. Yes, they have a tough job protecting us from medical products that are unsafe and/or ineffective. But when it comes to cancer, where we have few “homerun” therapies, I wish they were a bit more liberal. A “bunt single” might be good enough. You may have read how I have been critical of Dr. Rick Pazdur, the FDA leader for oncology drug approval. Some desperate patients and family members have referred to him as “Dr. No.”
Just the other day I interviewed a respected breast cancer survivor and patient advocate who has high respect for Dr. Pazdur. Musa Mayer of New York City is a 22-year breast cancer survivor and author of three books about breast cancer. She’s devoted her life to educating other patients about cancer and also playing a role in public policy. She has become a favorite patient representative on FDA cancer advisory boards and regularly weighs in when breast cancer drugs are being considered.
In my interview with Musa, she explained Read more »
*This blog post was originally published at Andrew's Blog*
August 16th, 2011 by Elaine Schattner, M.D. in News, Opinion
2 Comments »
Last Sunday’s New York Times featured an op-ed by Dr. Ezekiel Emanuel, on the oncology drug shortage. It’s a serious problem that’s had too-little attention in the press:
Of the 34 generic cancer drugs on the market, as of this month, 14 were in short supply. They include drugs that are the mainstay of treatment regimens used to cure leukemia, lymphoma and testicular cancer.
Emanuel considers that these cancer drug shortages have led to what amounts to an accidental rationing of cancer meds. Some desperate and/or influential patients (or doctors or hospitals) get their planned chemo and the rest, well, don’t.
Unfortunately, Read more »
*This blog post was originally published at Medical Lessons*
August 19th, 2010 by Debra Gordon in Better Health Network, Health Policy, News, Opinion, Research
No Comments »
Time to get back up on my soap box.
Next month the FDA is supposed to consider taking the unique, first-time-ever step of revoking a drug’s indication not because it’s dangerous, but because it doesn’t work well enough to offset its risks. Never mind that it costs about $8,000 a month.
The drug is Avastin (bevacizumab), a targeted monoclonal antibody that prevents tumors from creating and maintaining their own blood supply, a process called angiogenesis. Without oxygen and nutrients from blood, tumors can’t keep growing.
Avastin is the world’s best-selling cancer drug, approved for use with chemotherapy to treat lung cancer and metastatic colorectal and breast cancer. It is also being investigated (and, likely, being prescribed off label) for numerous other cancers. The problem comes with breast cancer. Read more »
*This blog post was originally published at A Medical Writer's Musings on Medicine, Health Care, and the Writing Life*