Some commentators are claiming that the FDA’s review of its earlier approval of the chemotherapy drug Avastin for the treatment of metastatic breast cancer is “death panel” rationing. I don’t think we know that–at least based on the Washington Post report about the controversy. From the story:
Federal regulators are considering taking the highly unusual step of rescinding approval of a drug that patients with advanced breast cancer turn to as a last-ditch hope. The debate over Avastin, prescribed to about 17,500 women with breast cancer a year, has become entangled in the politically explosive struggle over medical spending and effectiveness that flared during the battle over health-care reform: How should the government balance protecting patients and controlling costs without restricting access to cutting-edge, and often costly, treatments? The Food and Drug Administration is reviewing the recommendation of influential scientific advisers to revoke authorization of the drug to treat metastatic breast cancer. Contrary to initial research, new studies indicate that the benefits of the drug, which costs $8,000 a month, do not outweigh its risks, the advisory panel concluded.
The monthly cost is irrelevant to its effectiveness. But the cost doesn’t seem to really be the issue:
Citing a dearth of evidence of the drug’s effectiveness, its potential toxic side effects, and its high cost, many cancer experts, patient advocates and others are welcoming the prospect that Avastin’s authorization for breast cancer might be repealed. But the possibility is alarming other cancer specialists, women taking the drug, some members of Congress and advocates for giving patients as much access to as many treatments as possible.
This–meaning efficacy–is a factual question and should be reviewed if there is a meaningful question that it really works for breast cancer like it unquestionably does for other cancers. Indeed, that’s the FDA’s job. The cost issue has to do with whether health insurance and Medicare will cover the drug for use in breast cancer if FDA withdraws approval. The FDA should not take that matter into account one way or the other.
Bottom line: If approval is withdrawn because it doesn’t work–that’s not rationing. If approval is revoked based on cost/benefit–even though it does extend lives–that would be rationing. So, let’s chill until we find out. We don’t want to be the Little Boy who cried, “Wolf!”
August 16th, 2010 | 8:57 pm
[...] This post was mentioned on Twitter by Vince Humphreys, Fuisz Report. Fuisz Report said: SHS: Let’s Not Rush to Judgment About FDA Rationing Avastin http://bit.ly/dDbKpq #tcot http://bit.ly/bWKzRb [...]
August 16th, 2010 | 9:32 pm
I don’t know, Wesley. Sounds like rationing to me. It doesn’t matter what the side effects are-if they approved it before and are thinking about rescinding the approval due to the yearnings of some people who want to enact their own brand of health care reform, it sounds politically motivated.
Wesley J. Smith Reply:
August 16th, 2010 at 9:36 pm
We’ll see. I am saying let’s wait before judging. If it isn’t really a good drug, e.g., doesn’t extend life for breast cancer, while causing terrible side effects, it shouldn’t be used for that purpose–and false hope isn’t a justification. We will have efforts at rationing if Obamacare sticks. I don’t want to get our powder wet fighting something that may not be rationing. We need to see what develops.
August 17th, 2010 | 5:38 am
You guys should stop complaining cuz one the health care we have now isnt as good as it was supposed to be. also the law has just been signed give it a try u guys are too hard on democrats they went to college and we voted for most of these people.so if u want to say u have the right to choose tell that to ur congress men or state official. as for obama people are just tryin to make it look like america made a mistake he has done things to help us and we had a full 8 years of a terrible president and i will be so as happy as ever when a obama fixes bush’s mistakes. You can find full medical coverage at the lowest price from http://bit.ly/9fDY7U . obama has to put up with the world judging his every move and trying to fix the mess we are in we are lucky anyone wants to be our president. STOP COMPLAINING AND GIVE HIM A BREAK. i wanna see one of yall do what he has done. some people are just so ignorant.
Wesley J. Smith Reply:
August 17th, 2010 at 12:30 pm
jaydenro: None of that has anything to do with the post. Did you even read it?
August 17th, 2010 | 10:06 am
In my experience with a love one with cancer, Avastin does not offer a cure and thus could not be said to be any kind of “death panel” rationing. Avastin is mainly used for those who are in the late stages of metastatic cancer whose life, maybe, can be extended a month or two. That’s it! And Avastin runs the risk of makes holes in the tissues of your organs if not dosed properly.
According to Jules Berman, MD, Avastin only offers 4 months of life extension for ‘responsive’ patients. There is no cure for advanced cancer and likely will never be. Only removing precancers (polyps, lumps, moles, tobacco use, etc.) has resulted in any real avoidance of death. Therefore, denying pap smears, colonoscopies, skin exams, breast exams, etc. would be the only real “death panel” rationing. See Jules Berman, MD, PhD, Precancer: The Beginning and the End of Cancer (2010).
August 17th, 2010 | 6:38 pm
A balanced presentation! Bravo!
A good question for Breitbart’s Big Government, Hot Air, Red State and other components of the right-wing noise machine pushing this issue as rationing is “Why did the FDA allow the continued use of Avastin in colorectal, lung, kidney and brain cancer if their decision was based on costs?”. Why wouldn’t the FDA withdraw approval for all indications (and also block all off-label use)?
Avastin is not very effective in metastatic breast cancer, and can have serious side effects. The initial clinical trial, which was the basis for the original accelerated approval by the FDA, was not confirmed by subsequent trials. This is how the system should work.
The only rationing occurred when brains were distributed to right-wing bloggers. Next, they’ll calling for limits on the religious freedoms of Muslims.
Wesley J. Smith Reply:
August 17th, 2010 at 6:44 pm
Jeffrey, what others do is of no concern here. But your point about the other cancers is, I think, exactly the right point.
August 17th, 2010 | 6:58 pm
“Some commentators are claiming that the FDA’s review of its earlier approval of the chemotherapy drug Avastin… is rationing.”
The “commentators” in this case are Senator David Vitter (R-Hookerville), Andrew Breitbart and Mike Flynn at Big Government, the anonymous RedState Insider at RedState.com and Ed Morrissey at HotAir. This is becoming an increasingly common scheme amongst the hacks of the right-wing noise machine. A Republican misrepresents the truth, Andrew Breitbart (and Drudge, usually) amplifies it(ACORN, Shirley Sherrod etc) and it’s picked up by the lesser lights.
When one half of our citizens are led (and misled) by cynical dissemblers such as Vitter, Boehner, Inhofe, Breitbart, Beck and Limbaugh is their any hope for this nation?
August 17th, 2010 | 8:48 pm
From what I’ve been able to review, the initial FDA thumbs-up for Avastin was via an “accelerated approval”, a mechanism that allows for conditional approval of drugs based on encouraging preliminary evidence. This is a process we should be happy to have in place when the stakes are high (as with advanced cancers). It’s also a conditional mechanism, stipulating that definitive trials must be performed demonstrating effectiveness for a definitive endpoint. If a drug or treatment doesn’t show significant benefit in those, approval can be rescinded.
It might serve as some context to remember that the FDA’s accelerated approval of Avastin for breast cancer in 2008 was contrary to its advisory panel’s recommendation, based on what some deem controversial surrogate endpoints of efficacy, and was not without criticism within the oncology community.
It’s possible that cost focused attention on Avastin’s reappraisal, but despite the breathless expressions of outrage popping up in the blogosphere, I’ve not seen any hard evidence that the advisory committee’s recommendations were politically pressured. And there’s nothing in the panel’s briefing document about cost-effectiveness.
August 18th, 2010 | 7:54 pm
Unfortunately, should the FDA rescind approval of Avastin for breast cancer, there will be a great and most unjoyous noise–weeping, wailing, and gnashing of teeth. Avastin is almost never used as a single agent. In breast cancer, it is typically used with paclitaxel, docetaxel, or capecitabine–drugs of known efficacy in that disease. If a patient is doing well on the combination, there’s no way of knowing whether Avastin is contributing to that success. But the patients and their families will surely ascribe benefit to Avastin in that setting. They’ll rally political pressure on the
FDA, Medicare, private insurers, etc. Then we may expect to see what has long been predicted in the rationing debate: political interference in scientific decisions. The politicians don’t care about efficacy, safety, contraindications, statistical significance, etc. They care about votes, and aren’t too fussy about how they get them.
August 18th, 2010 | 10:42 pm
“Avastin is mainly used for those who are in the late stages of metastatic cancer whose life, maybe, can be extended a month or two. That’s it! And Avastin runs the risk of makes holes in the tissues of your organs if not dosed properly.
According to Jules Berman, MD, Avastin only offers 4 months of life extension for ‘responsive’ patients. There is no cure for advanced cancer and likely will never be. Only removing precancers (polyps, lumps, moles, tobacco use, etc.) has resulted in any real avoidance of death. Therefore, denying pap smears, colonoscopies, skin exams, breast exams, etc. would be the only real “death panel” rationing. See Jules Berman, MD, PhD, Precancer: The Beginning and the End of Cancer (2010).”
Two months or four months-they are months that the patient may want and would not otherwise have. It’s up to them, and it shouldn’t be up to anyone else.
August 19th, 2010 | 8:08 pm
safepres,
Is your last statement meant to imply that the FDA not regulate drugs?
September 1st, 2010 | 8:21 pm
[...] isn’t based on efficacy–which is being questioned by the FDA regarding the drug’s use for breast cancer–but pure cost/benefit and quality of life judgmentalism. (Can you imagine if an HMO did [...]
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