Every time I think we’re past this, someone wheels it out again. Seems like I can’t turn around without someone smacking me in the face with “death panels”.
Godwin’s law states that whenever someone making an argument brings up Adolf Hitler or the Nazis, that person effectively forfeits the argument.
I’d like to propose Carroll’s Law. Here it is: When anyone discusses health care policy, it becomes increasingly likely that someone will bring up “Death Panels”. When that happens, that person immediately forfeits the argument.
The Avastin mugging is really an attempt to undermine regulatory modernization like accelerated approval that offends the FDA’s institutional culture of control and delay. It is also meant to discourage innovations like Avastin that the political and medical left has decided are too costly, with damaging implications for the next generation of cancer drugs.
What’s this all about?
Let’s review. There was a recommendation made by the FDA’s independent advisory panel, which came out 12-1 on July 20 to recommend the revocation (kudos to the Wall Street Journal for their timely efforts to discuss this). The panel was only talking about using Avastin for breast cancer, not treatment of other cancers, for which the drug continues to enjoy approval:
The FDA in 2008 approved Avastin for breast cancer patients based on a trial showing it extended the amount of time until the disease worsened by more than five months. The decision was considered controversial by some cancer doctors because the drug had not been shown to extend patients’ lives…
“The study shows there’s very little benefit to patients with significant toxicity risks and no clear survival benefit,” said Natalie Compagni Portis, the panel’s patient representative.
I think it’s worth noting that as part of these panels, they always make sure the public is represented by a patient representative. Ms. Portis is a breast cancer survivor, and a past board member of Breast Cancer Action. Does the WSJ think she’s running the death panel for breast cancer patients?
I know there’s the temptation to make everything politics. But it is possible, especially in things like independent advisory panels, for decisions to be made for reasons that have nothing to do with a party’s agenda. Especially when so much of what they do is public. Here’s how the FDA independent advisory panel came to its decision:
In trial results submitted to the FDA by the drug’s U.S. maker, Genentech Inc., use of Avastin (bevacizumab) did boost the progression-free survival of women with advanced breast cancer by an average of 5.5 months, when combined with the chemotherapy drug paclitaxel. Progression-free survival refers to survival without any advancement of the malignancy.
However, the same Genentech study of 722 patients showed that patients reaped no gain in terms of their overall survival after taking Avastin.
Another company-funded trial, this time including 462 patients with advanced breast cancer, showed similar results, with Avastin having no effect on overall survival.
At the same time, the FDA said, the drug has “major safety issues,” including hypertension, clotting events, left ventricular heart dysfunction, heart attack, gastrointestinal perforation and proteinuria (excess protein in urine). A special FDA staff review of the data found that rates of grades 3 to 5 toxicities rose by more than 20 percent when cancer patients received Avastin on top of regular chemotherapy.
FYI, here is Breast Cancer Action’s letter supporting the panel’s decision. I assume the WSJ will be attacking their motives as soon as possible.
A woman named Roberta Gelb offered testimony to the committee. Ms. Gelb is a breast cancer surviror and a member of SHARELeaders, which is a group of breast cancer patient advocates who have completed the National Breast Cancer Coalition’s science course. You can read her testimony in its entirety here:
The general consensus of SHARELeaders is that Avastin should not be approved as first line treatment for metastatic breast cancer.
The members of SHARELeaders advanced several different lines of argument for their decision. The first is that the trials subsequent to accelerated approval failed to demonstrate a clinically meaningful benefit, that is either an improvement in overall survival or a sufficient magnitude of progression free survival together with improved quality of life. Therefore Avastin should not be approved.
Another line of argument raised by SHARELeaders, although not directly relevant to the more narrow issue at hand, is whether progression free survival should ever serve as a credible endpoint in breast cancer research. We survivor advocates strongly believe that overall survival without compromising quality of life must remain as a primary goal of research; some believe it is the only goal. We want drugs that extend our lives and not merely the length of time until progression of our disease. Overall survival as an endpoint also enables us to know what late toxicities may arise in longer term use of the drug or even after the drug is no longer being used.
While overall survival is clearly a research goal, some SHARELeaders argue that a meaningful progression free survival time frame combined with few toxic side effects and better quality of life, could be an acceptable endpoint particularly in metastatic disease.
The Avastin results failed to show either overall survival nor any clinically meaningful progression free survival; there were critical, toxic and unacceptable side effects and little quality of life data. Any risk-benefit analysis would strongly suggest that Avastin should not be approved at this time.
Will the WSJ be attacking Roberta Gelb and SHARELeaders as death panels?
Let’s be clear. It’s proven, and no one is denying, that the drug has serious side effects. It is uncertain that it’s doing any good. So the independent advisory panel recommended that its previous approval – contingent on specific outcomes that did not occur – be revoked. I’m curious what results would have to occur for the WSJ to oppose the drug.
I have no problem with debate and discussion. That’s why the independent advisory panel exists. And remember, Avastin is still approved for the cancers it has been proven to help. I don’t think it’s crazy or immoral to think it’s not a good idea for us to take drugs in situations where they are known to hurt us and not known to help us. Can we manage to talk about that without wheeling out death panels?
Now back to me. I really like this Carroll’s Law thing. Please help me make it a reality!