This drug went from being a 'candidate' molecule to having gold standard data and FDA approval in 5 years.
Five years! I know that's fast by industry standards. Why, it's only one more year than it took us to win World War II. Also, for a full measure of the OODA loop, you should start counting from when the target was discovered.
The way you conceptualise a cancer patient's plight is also insulting and grotesque. They are not nihilists willing to try anything, who we can gladly sacrifice in our pursuit of cure. They have family and friends, and they really want to go their granddaughter's wedding next month and if you harm them with loosely justified bullshit science, you haven't helped anyone.
"Insulting and grotesque" is apparently in the eye of the beholder. I actually find this attitude pretty insulting and grotesque.
Some patients, it's true, are very comfortable being paternalized. Both my grandfathers were killed by the present standard of care in prostate cancer, "watchful waiting." They were both men who would have died rather than challenge an authority figure. And die they did.
Honest question: would you be less bitter about your grandfathers' death if they had been given some unproven, entirely experimental risky drug...and then died immediately after because of said drug?
How would you feel about your grandparents being used as a few more numbers to confirm that a drug is not, in fact, effective or safe in treating prostate cancer?
Honest question: would you be less bitter about your grandfathers' death if they had been given some unproven, entirely experimental risky drug...and then died immediately after because of said drug?
I'd feel much better about it. Because I know that they'd have been killed in the front line by a shell - not in the Paris latrines by cholera.
My father's father fought in the Battle of the Bulge. They weren't pussies back then, you know.
How would you feel about your grandparents being used as a few more numbers to confirm that a drug is not, in fact, effective or safe in treating prostate cancer?
Typically when you're trying to "confirm" something it means you think you know it anyway. No, I don't think any p-value is worth dying for.
Your turn. Honest question: here's a story by a UK woman who jumped for joy to learn her cancer had spread, because it meant she could get into a trial:
No need to get hostile. My girlfriend's mother died from a very aggressive cancer just last year - I'm well aware of the painful reality of both cancer and treatment.
Regarding my comment about confirmation, there are always points in any experiment where you basically know the outcome, but just need a few more datapoints to pass that magical p < 0.05 number. At that point, they are technically just killing people and wasting time.
Of course that is a terribly cynical viewpoint. You could easily reword it to sound much more positive. But I think my original point still stands.
There are always going to cases like the woman's above - it is inevitable. You can't immediately clear everyone for every drug. Some drugs are only effective when the cancer has progressed to a certain point. But barring technical problems, there just simply isnt enough money to pay for everyone to have every experimental treatment.
Triage and thresholding is an unfortunate necessity.
Absent from your entire discourse, is any notion of a good death. I've looked after people who wanted to try everything, fly anywhere, even when they weren't strong enough to sit up in bed. They didn't die well.
It has never been shown that treating cancer patients up until the time of death makes any difference to either quality of life or survival (http://www.biomedcentral.com/1472-684X/10/14). Sometimes there is a tyranny about the biology of cancer that is difficult to overcome even with agents that are known to be effective, not even when you have run out of all drugs completely.
You might scoff at the notion of a good death. But then there is this trial (http://www.nejm.org/doi/full/10.1056/NEJMoa1000678). This was a trial which compared early palliative care with late palliative care involvement for patients with metastatic lung cancer. They were otherwise treated with standard therapy/clinical trials/whatever was available. Astonishingly, those patients that received early palliative care had less treatment overall and lived nearly 3 months longer - by getting less treatment, and focusing on quality of life. If there was a new drug that helped people with lung cancer live 3 months longer, it would be revolutionary.
On the basis of this evidence and my personal experience, I believe there is potential harm in taking the attitude of wanting to try everything by default. This attitude may be right for some people, but for others, it may shorten their lives for no benefit and leave them and their families unprepared for the inevitable end.
There is no escape from the notion that the latest drug might just turn everything around. It is certainly true that when a drug like this comes along, there will be some people who miss out and die because they or their doctors didn't try hard enough. But how much potential harm can you justify because of this tiny, tiny risk?
Five years! I know that's fast by industry standards. Why, it's only one more year than it took us to win World War II. Also, for a full measure of the OODA loop, you should start counting from when the target was discovered.
The way you conceptualise a cancer patient's plight is also insulting and grotesque. They are not nihilists willing to try anything, who we can gladly sacrifice in our pursuit of cure. They have family and friends, and they really want to go their granddaughter's wedding next month and if you harm them with loosely justified bullshit science, you haven't helped anyone.
"Insulting and grotesque" is apparently in the eye of the beholder. I actually find this attitude pretty insulting and grotesque.
Some patients, it's true, are very comfortable being paternalized. Both my grandfathers were killed by the present standard of care in prostate cancer, "watchful waiting." They were both men who would have died rather than challenge an authority figure. And die they did.