http://online.wsj.com/article/SB1000142 ... lenews_wsj
"The Avastin Mugging"
This is an editorial decrying the FDA decision to de-approve Avastin Rx for breast cancer, noting, "The decision betrays a bias that puts costs above treatment, and unless the FDA leadership overrules its own experts, the 40,000 women killed by breast cancer each year will be denied an important clinical option."
Oh nelly. Here's what's wrong with their thinking:
"Roche's Genentech unit charges as much as $88,000 annually for an Avastin breast cancer regimen, reflecting the costs of development and production."
So it's insanely expensive, agreed. But why? If you agree with their logic please go read: http://www.slate.com/id/2264116/
They go on to admit Avastin does not prolong life, only progression free survival. In other words, your breast cancer appears the same size a bit longer, then kills you at the same time it would have without the drug. Why does this matter? For:
"minimizing psychological suffering and offering hope."
Hope that you won't have your life extended? How about... an antidepressant (essentially free)? A spiritual counselor (you can have your own, full time, for 90k a year!)? Wait, how much time are we talking about?
"Critics claim these effects are worthless because they translate into only one to three extra months before tumors worsen."
That's it: 4-12 weeks of not being told your cancer got worse. Know how else you can accomplish that? SKIP A CT SCAN. Many cancer patients get serial scans just so we can tell them their tumor is shrinking or growing; they experience no change in symptoms from this. Unless a scan is absolutely required for treatment decisions, skip em. We know that imaging costs especially for cancer are skyrocketing. We're spending billions giving people drugs and scanning them often just so we can comment on tumor size and progression when these scans and drugs offer no meaningful benefit to patients. Super! What else you got, editorialist?
"The median overall survival benefit for one subgroup of 496 patients between the ages of 40 and 64 was an additional 5.7 months of life. Some individuals gain years. At any rate, even the 31% reduction in the risk of disease progression or death is better than the status quo."
Ah, I love being lied to. Here, they're pulling one subgroup out of one trial and inflating that mortality benefit as a bit of hope cancer patients can fixate on. There may be mortality benefits to some and not other patients, but the same editorialists admit,
"Patients did not live longer."
The summary experience is that it doesn't prolong survival. Because of random variation, especially in subgroup analyses, there may appear to be signal when there is just noise. OVERALL, what do we know, what do they admit? No prolongation of life. Why, if they claim some patients get another half year? Well, some breast cancer patients life many many years with metastatic disease. Without Avastin. Avastin can't claim credit for a few long term survivors; that's just cancer. And further, Avastin has
"...safety issues such as toxic side effects. The latter can include severe bleeding and other life-threatening complications, though they are manageable."
So guess what? Even if we assume they're right that some people live longer because of Avastin, there is an equal and opposite harm from life threatening (I would say life ENDING) effects. That's why "no overall surivival benefit"). You are spending 90k a year to prolong life as much as you shorten it.
Now, I'm not totally against approving this drug, and letting doctors and their patients decide the risks, but the editorial notes,
"But private insurers and Medicare are reluctant to cover treatments that aren't recommended by the FDA."
No Sheet! I would NEVER propose that medicare or private insurance go towards a therapy that extends "progression free survival" and not survival for 1-3 months at a cost of 90k a year. THAT expense, let's remember, is between $360,000 and $1,080,000 for year a patient goes without hearing their cancer is worse on a scan without any difference to their clinical outcome.
Do we have $360-1080k to spend on a year of progression freedom? NO!
Do we have $360-1080k to spend on a year of SURVIVAL benefit (with metastatic cancer)? NO!
Do we have $360-1080k to spend on even a QALY (a QUALITY year of life)? NO!
If you think about it, there is simply no way an average American can contribute enough to the medical resoures we have to spend to receive this therapy. Treatments this expensive are NOT sustainable; we will NOT be paying for them in the future, as we will either decide not to (we will give up on our "any expense" rescue fantasies for dying patients and focus on more cost effective therapies that prolong quality years, prevent disease, and treat ill people more efectively) OR we will be forced not to pay for these things because we can't (I wonder if Greece is paying for Avastin these days, hmmm). A more reasonable limit for a QALY is like 50 to maybe $100,000 (note: topic of bitter debate). IF this medicine were approved, it would be terribly unwise to require medicare or insurers to pay for it. Perhaps people who want such terribly inefficient healthcare could pay double or triple rates IN ADVANCE for this protection, just as they may pay more for "replacement cost" or "no deductible" home or car insurance. But we must not demand these things.
This is really pathetic. If and when we are really sick, we can think about more than ourselves and also about the state of the system we'll be leaving behind (in this case, at the same time of departure). And know that if a therapy is denied for being marginally useful, it's not a big deal anyway: it's a marginal therapy. THAT kind of reason in the face of illness will never come about while we're reading editorials like these. *I* for one am more worried about what I can do for the length and quality of my life (living right) than I am about such barely useful treatments I may need when terminally ill. Most people would live longer if they spent their time on a brisk walk than on moaning to the FDA about this.