“Death Panels” Back in the News
Is 5½ months of improved quality of life worth $88,000? An FDA panel says “no”:
Roche’s Genentech unit charges as much as $88,000 annually for an Avastin breast cancer regimen, reflecting the costs of development and production… As for survival, Avastin hasn’t been shown to extend life on average…
Yet a clinical trial showed a 52% median improvement in “progression-free survival,” which measures the time women live without their disease spreading or worsening. In practice, this means delaying the growth of tumors by about 11 months in combination with chemotherapy—five and a half months longer than chemo alone.
Full Wall Street Journal editorial on the FDA vs. Avastin. UK Telegraph on “death panels” coming to the U.S. here.
Suppose we were talking about automobiles and I asked you is $88,000 too much for a top-of the-line Lexus? Your response should be, it’s too much for some, about right for others and possibly too little for real fans. In a free society, we don’t have to live with same-decision-for-all rules. We can each decide for ourselves.
I’m with Ken. Why should the FDA have the power to prevent us from making choces like this????
Many scientists believe that an advanced cancer combo drug, that uses multiple pathways to fight cancer, is our best hope. Taking multiple drugs in combination with each other has made a huge difference in fighting AIDS. However, the FDA makes it harder to test and approve a drug that contains more than one pathway until each individual compound has been shown to be safe and effective. Drug companies are afraid to collaborate — believing getting their respective drugs approved individually is the easier route. That could essentially force patients to take three expensive drugs rather than one expensive drug that is made up with three compounds.
Whose life is it anyway? The FDA thinks your life isn’t yours.
This WSJ editorial is a gross misrepresentation of the research on Avastin. If anything, Avastin made breast cancer patients worse, not better. Here are quotes from an accurate account.
“For some of us, the core question at that time was whether or not women had a better quality of life during that period of extended progression free survival, even if the drug did not increase the length of their days. The thinking was that even if total survival wasn’t improved, at least if they had better function and less pain, it would still be worthy to consider the drug effective. Unfortunately, the studies were not designed to give an answer to that question.
Now come the two new studies, and the news wasn’t particularly impressive that bevacizumab made a real difference in the treatment of the women in the trials.
According to an FDA report, although the drug was effective in increasing the progression free survival, the duration of that effect was around 0.82 to 0.88 months in one study and 1.2 months in the other. When looking at survival, there was no real difference in women who received bevacizumab compared to those who did not. In fact, if anything, the data suggested (but did not prove) that women who did not get bevacizumab lived longer than those who did.
The safety review of the drug also showed many more severe adverse side effects when bevacizumab was added to the treatment regimens”
http://www.cancer.org/AboutUs/DrLensBlog/post/2010/07/20/The-FDA-and-Avastinc2ae-Breast-Cancer-Patients-Are-Thrown-Another-Curve-In-An-Ongoing-Saga.aspx
The initial study which is quoted here, was not deemed appropriate fro reaching any conclusions. The follow up studies show what artk notes above. The drug, which works well for other cancers, does little for breast cancer.
I spent the morning doing mastectomies with a breast cancer researcher. He will not be using Avastin on his patients as the follow up studies confirm his clinical experience. No improved survival and lots of side effects making those last days more miserable.
Frankly, I dont see how anyone with a sense of ethics and knowledge of health care issues could write this piece without mentioning the follow up studies designed to look specifically at Avastin and breast cancer.
Steve
steve sez: “I dont see how anyone with a sense of ethics and knowledge of health care issues could write this piece”
I can answer that. By distorting the facts, it fit an uber free market government is always bad narrative.
Nothing about the safety or efficacy of this drug, or any other drug, has anything to do with a free market. In a free society, people are free to consult the evidence and make their own decisions. They don’t have to ask permission from a regulatory agency. There will always be drugs that are safe for some purposes and not safe, or at least risky, for others.
As a factual matter, economists have concluded that the FDA appears to do more harm than good. But that is another issue.
I agree with John, I believe the FDA does more than good. Such an organization could be replaced by other private professional organizations and ratings companies that can do a much better job assessing the safety and efficacy of drugs.
[…] illustration of Carroll’s Law? John Goodman’s post “Death Panels Back in the News”. It discusses this editorial in the Wall Street Journal: The Avastin mugging is really an attempt […]
Because we have a serious challenge here to the Wall Street Journal editorial, I have invited Genentech to respond – either in a comment or in a regular post.
Sure John, you can be sure that with 6 billion dollars a year in Avastin sales, Genentech will give you a completely unbiased response.
“Nothing about the safety or efficacy of this drug, or any other drug, has anything to do with a free market. In a free society, people are free to consult the evidence and make their own decisions.”
Then you should present the evidence, not just one study. As I am sure you know, that study was thought inconclusive so follow up studies were done. Those should be mentioned. God forbid someone with breast cancer read this and think that Avastin is actually a good drug for breast cancer.
Steve
Genentech declined our comment to defend themselves at this blog, but they did offer a defense in USA Today (http://bit.ly/bm7qV5), in response to the newspaper’s own editorial attack (http://bit.ly/9CVXNz).