“With this disappointing decision, the FDA has chosen to place itself between patients and their doctors by rationing access to a life-extending drug. . . We can’t allow this government takeover of health care to continue any longer.”
That quote, courtesy of this morning’s Washington Post, incensed me to such a degree that I am writing this blog despite the two deadlines I have today. The speaker is Sen. David Vitter (R-La). The “disappointing decision” he refers to: The FDA’s decision to remove the breast cancer indication for Avastin (bevacizumab).
I wrote about this earlier, and you can read the post here, but that was before yesterday’s decision. I’m not going to comment here on the benefits or risks of Avastin. . . except to say that I’m sure there are individual women who are alive today because of it, and, quite possibly, individual women who are dead today despite it. But that’s not how we do medical science, based on individual patients. We do medical science based on large clinical studies (which are often designed with and approved by FDA officials). It’s not a perfect system, but it’s the system we have.
For more than 50 years, that system has included the role of the FDA in approving drugs for marketing based on two things: their clinical efficacy and their risks. Which tips the scales higher? Are there other options available with better efficacy and fewer risks? If this is government takeover of health care, than I say. . . bring it on.
I don’t know about you, but I’ve got enough on my plate what with earning a living, nagging the 18-year-old about college and scholarship applications, advising the 14-year-old on girlfriend issues, figuring out tonight’s dinner, making sure my husband feels appreciated and loved, keeping up the house, and tossing the ball for the puppy to add “assessing risk/benefit ratio of pharmaceutical compounds” to my to-do list.
I also appreciate the government “interfering” in health care when it requires that medical professionals meet certain requirements for licensing; that hospitals and other healthcare facilities follow certain rules and regulations for safety and quality; and that drugs be manufactured according to good manufacturing guidelines. I’m only 48, but when I’m 65 and get my Medicare card, I think I’m also going to embrace that form of government “interference” in my healthcare.
Your thoughts?
5 Responses to “Quote of the Day”
Carolyn Thomas
Call me cynical, but I can't help but wonder if Sen. David Vitter's opinion on the FDA's “disappointing decision” might be ever-so-slightly colored by any conflicts of interest? Any undisclosed campaign contributions by Big Pharma companies like Genentech, Inc.- (manufacturers of Avastin)? Any company stocks/shares held? Any friends in powerful drug marketing lobby circles?
What on earth could otherwise cause a politician such disappointment in reaction to evidence-based science?
Lori
The National Comprehensive Cancer Network lists 10 single agent chemotherapy regimens and 8 combination regimens as preferred first-line treatments for metastatic breast cancer. For HER2-positive MBC, there are 4 trastuzumab-based regimens.
Avastin was being used in combination with chemotherapy for HER2-negative disease because there are currently no other targeted therapies for these patients. However, the data just don't support that adding Avastin to the chemotherapy regimen adds value.
We have multiple chemotherapy options for HER2-negative MBC. It would be wonderful to find a targeted therapy to add to these regimens to further increase survival relative to chemotherapy alone. However, that agent is not Avastin, or at least no clinical trial to date has been able to demonstrate that. Even the less difficult to demonstrate endpoint of progression-free survival is not clearly and consistently improved when Avastin is added to chemotherapy.
As a taxpayer, knowing that Medicare pays for a lot of cancer therapy in this country, I can't support the indiscriminate use of Avastin in MBC at this point in time. There are numerous phase III clinical trials underway with novel agents in this setting that people could participate in to try to move the field forward. Plus, Avastin is on the market for other uses; people who feel strongly that they want to receive it can pay out of pocket, just like they do for other unproven, off-label therapies.
DayBreak Ventures
The reality is many people in the United States are diagnosed each year with an advanced cancer that is not curable. For these individuals, there is clearly a need for multiple treatment choices.
Assisted Living In San Antonio
Deb Gordon
oooh, Lori, you make a lot of arguments I wish I'd thought of! Thanks so much for posting and for reading.
I think one of the frustrating things right now with clinical trials is that they are not designed to identify the patients for whom a drug might work; it's an all or nothing approach. I see this particularly in lupus.
Deb
Lori
Bravo, Deb! I was incensed all day yesterday too. And I wonder how strongly David Vitter has come out about the denial of organ and marrow transplants happening in Arizona right now based on nothing more than a patient's ability to pay? Oh, right, Republicans in AZ are behind that one, so nothing to see there.
I've worked in oncology for the last 20 years, and I agree with the FDA decision in this case. Avastin does not extend life in metastatic breast cancer (ie, women who receive it do NOT live longer than those who do not receive it). One study suggested it extends progression-free survival by a few months, but subsequent studies could not confirm even that less compelling outcome. It has side effects, which become less acceptable in the absence of clear clinical benefit.
So my take? We need more research. Yes, yes, that sounds like a cop-out. But one of the biggest issues with Avastin today is that we can't identify in advance who might benefit, which we can for other “targeted” therapies. We know women with estrogen receptor-positive breast cancer benefit from tamoxifen and aromatase inhibitors. We know those with HER2-positive disease benefit from trastuzumab. What we need to find out is whether there are subsets of patients with breast cancer, an incredibly heterogeneous disease, who benefit from Avastin so that we can study its use in that population and then prescribe only to those who are most likely to benefit.
The FDA decision is actually evidence-based medicine at its best. Given the ballooning federal deficits, you'd think the party that says its concerned about debt would be happy not to spend millions of Medicare dollars on an ineffective therapy, but then, that doesn't make for very good political theater.