The recent controversy leading up to and resulting from the FDA’s Oncologic Drugs Advisory Committee’s decision to withdraw its approval of Roche/Genentech’s drug Avastin for the treatment of some advanced breast cancers, seems to me, to be a perfect example of what sometimes happens when science and emotion collide.
And as so often is the case in collisions, the real victims are innocent people, in this case women with advanced HER2-negative breast cancer.
First some very basic background.
In February 2008, the FDA granted accelerated approval for the use of Avastin in treating certain advanced breast cancers. Since then it’s primarily been used in combination with paclitaxel (commonly used chemotherapy drug) for the treatment of advanced HER2-negative breast cancer.
This accelerated approval was in and of itself not without controversy. Dissenters claimed insufficient data existed to properly establish that benefits outweighed the risks.
Wasn’t this an immediate red flag?
Avastin’s use for the treatment of certain advanced breast cancers none-the-less moved forward offering hope to patients with few options remaining on the table for them.
Notably, Avastin is one of the most expensive and widely marketed cancer drugs in the world, bringing in around $6 billion annually. Roche stands to lose $1 billion of this figure if sales of Avastin for breast cancer treatment are suspended.
Avastin is the trade name for Bevacizumab and is generally given to a patient to stop or slow tumor growth by preventing formation of new blood vessels which feed the tumor. It also inhibits the function of a natural protein called vascular endothelial growth factor, or VEGF-A, which stimulates new blood vessel growth as well as healing and repairing of the vascular system. Avastin has been used to treat other metastasized cancers such as colon and lung since 2004 when it was first approved.
This leads us to one of the greatest problems/side effects of Avastin, that being interference with normal function of blood vessels. Inhibiting growth is good in regard to tumors, but not when it inhibits normal growth and maintenance of blood vessels throughout the body. This can lead to coronary heart disease as well as a host of other problems.
Other adverse side effects include hypertension, heightened risk of bleeding and bowel and nasal perforation to name a few.
Some such side effects have been extreme, even resulting in death.
Another issue with Avastin is the data has been inconclusive as to what exactly is benefiting the patient, the Taxol or the Avastin.
Does the Avastin boost Taxol’s effectiveness?
Who cares about any of this you might ask, especially if you are a woman living with stage IV HER2-negative breast cancer and presently taking Avastin?
What do you do when you have no other options?
This is where the recent emotional testimonies came into play. Women pleaded, some with tearful testimony, trying to make the case for keeping Avastin an option for them. Heartbreaking stories were told; stories from real women, stories about life, death and few other options.
This is where separating painful testimonial and scientific fact becomes excruciatingly difficult.
The main fact coming into play in this case was that Genentech/Roche was unable to prove patients’ overall survival (OS) or quality of life improved, not just progression-free survival (PFS), meaning tumor growth was slowed.
Admittedly, this part bothers me. Should short-term PFS be enough?
Apparently, weighing this fact and others, together with the serious potentially deadly side effects, was enough for the FDA to withdraw its approval for Avastin.
Shouldn’t the FDA know what’s best? I sure hope so.
The manner in which all of this has been handled makes me skeptical, but ultimately, I do support this decision. I have to side with science.
In my opinion, there is also potential danger here in parading patients around, who may or may not be in a vulnerable state of mind, in front of the media to promote a position. I think there is danger of patient exploitation here. It’s a fine line.
A couple of important points seem to be missing from the recent conversations. One being that a patient and his or her doctor can still opt to use Avastin regardless of the ruling. Also, Medicare has said it will continue covering the cost, at least for the time being, for women already on the drug.
These are important points, because no matter what, the final decision regarding continuing to use Avastin or not must be made on an individual basis by the patient and her doctor.
But, what about the women who want to continue on Avastin and are not on Medicare? Will insurance companies continue to cover this cost? Again, I’m skeptical, although with pressure being put on them to do so, they may be forced to. I hope so.
How long will sorting all this out take?
Many patients taking Avastin don’t have the luxury of having lots of time to spare.
I don’t think this controversy is ending any time soon. The final decision will be made by FDA Commissioner Margaret Hamburg, MD, who as I understand it, can support or reject the committee’s recommendation.
In my opinion, this whole process of getting a new drug to the patient needs improvement, including better accountability, so this kind of fiasco doesn’t happen when a new drug comes down the pipeline.
We need more and better research, including more and better designed clinical trials. We need heavier emphasis on safety and the development of treatments with less debilitating side effects.
We need more and better everything for women with metastatic breast cancer.
We need to do better.
Cancer patients deserve better.
We all deserve better.