Last week I had an ultrasound guided needle aspiration of a breast cyst. Everything is just fine, garden variety cyst, but since nothing is too personal to blog about, I wanted to share the experience with my devoted reader.
My boob was pumped full of Novacain so I didn't feel anything, and was able to watch the whole procedure on the ultrasound monitor. The doctor sucked the cyst fluid out with a syringe, and then because of some indistinguishable gray blobs on the screen, took some tissue samples, too. When I did look down at the end, gah, glad I didn't look down before because it was bloodier than I thought it would have been and also the implement the doc used to take the tissue samples looked like a caulk gun.
The coolest part was watching the needles, which appeared like a thin white line on the monitor, pierce the wall of the black blob of a cyst, and deflate it in the blink of an eye. The cysts walls stay, and though there's a chance that it will fill up again, the good news is that it will always be benign. I felt just the littlest bit sick when he showed me the teeny worms of tissue floating in a jar and the syringe full of yellowish fluid to be sent off to the lab. All that remains is a small puncture wound surrounded by a bruise and that, as they say, is that.
A day after this, the FDA approved the use of Avastin for breast cancer. Already approved for colorectal and lung cancer, Avastin brought in 2.3 billion last year in the United States alone for its creator, Genentech. So far sounds like good news for women, especially those living with breast cancer, waiting for the next drug. But there's a slight catch: the FDA approved the drug against the recommendation of its own advisory panel. In studies, Avastin had slowed the growth of tumors, but not increased survival rates. Here's the text from the committee:
Many committee members agreed that Progression Free Survival is a clinically meaningful endpoint but had issues with how best to measure this endpoint. Although the overall survival (OS) endpoint was not met, most felt that no progression is better than progression in the minds of patients. The committee also reaffirmed that if PFS is to be used then studies must also be powered for survival to ensure that benefit out way the risks. One committee member mentioned that an overall survival requirement in 1st line breast cancer is difficult to achieve due to
challenges with monitoring.
Please see the transcript for detailed discussion.
2. Summary results:
• Estimated 5.5 month improvement in median PFS claimed by Genentech
• No improvement in OS
• Increased toxicity/toxic death
• No effect on PFS or OS in 2nd and 3rd line MBC
Are the data provided sufficient to establish a favorable risk/benefit analysis for the use of bevacizumab plus paclitaxel for first-line treatment of patients with metastatic breast cancer ? (Voting Question)
Vote : Yes=4 No = 5 Abstain = 0
Not all advocacy groups are pleased with this new option. The National Breast Cancer Coalition opposes the move, saying that the FDA has "lowered the bar" by approving a drug that is not shown to be effective or safe. You can read NBCC's thoughts about Avastin here.
This is a tricky one. Even if the drug approval is ultimately pulled, as was the case with AstraZeneca’s lung cancer drug, Iressa, when trials showed it did not prolong survival, Genentech stands to makes buckets of money from the increased prescriptions that will accompany expanded FDA approval. But, it also means that many more women will have another treatment option available to them, since many insurers will not pay for "off label" prescriptions.
Of course what lies at the very root of this issue is that the American health care system does not meet the needs of most Americans, the line between science and industry is way too permeable and neither Clinton, who offers mandated insurance with penalties for those that don't comply, nor Obama, whose refusal to mandate health insurance could still see more than 15 million people uninsured, seem to offer options that are really what we need, truly universal healthcare.
Happy Monday!