Skip to comments.Prostate cancer drug so effective trial stopped
Posted on 06/03/2012 12:12:44 AM PDT by LibWhacker
A new drug for advanced prostate cancer patients has proved so effective that researchers stopped the clinical trial early to give all patients a chance to receive the life-extending medication, according to a UCSF-led study released Saturday.
The hormone treatment, Johnson & Johnson's Zytiga, when added to a standard steroid therapy doubled the time it takes for the disease to progress in patients treated with the standard therapy alone, said the lead researcher, Dr. Charles Ryan, associate professor of clinical medicine at the UCSF Helen Diller Family Comprehensive Cancer Center.
(Excerpt) Read more at sfgate.com ...
If this study is correct - fantastic!!!!
This sounds good. However, we have been bitten in the past by cutting testing short. I hope they closely monitor the use.
So they ignored the whole point of a clinical trial.
‘We stopped the trial because the drug was working too well’ is always a red flag.
Apart from the problem of cherrypicking early (possibly idiosyncratic) results, what if the drug causes horrific side effects that don’t manifest in a truncated trial?
It’s just bad reporting, sensationalism. Drug trials go on forever in the form of data gathering and data management long after market approval.
The FDA still has to approve use on the market, based on the trial data.
This is a medication is one of last resort. It is not a cure but simply life prolonging. The qualification to get on it as of about last May was having literally months to live. My dad took it for about two months up till about his final 6-8 weeks. By them the chemo had taken it's toll on him. He was one it really didn't help but I possibly could have if he had been able to start it earlier. His Oncologist said he had seen good results with it in most of his other patients.
Does that mean it slowed by double or sped up by double?
Apparently you haven't watched TV in the last decade.
You call Kyles dad.
Relax. It will still be 15 years before it’s on the shelf.
Same thing happened with a drug that treats colon cancer. 90% effective. Don’t believe me? It’s called DFMO.
Yet people die from colon cancer every day. Thank FDA for that.
I am sure that most doctors hope they can “cure” their patients. But big pharma doesn’t make as much money “curing” a disease as they do “treating” a disease. When your insurance runs out, you’re toast.
DFMO caused hearing loss so doctors didn’t want to use it.
It wasn’t the FDA, it was the clinicians. They are restarting the trials with longer, lower doses. My dad died of colon cancer.
The problem is that the press screams “Miracle cure!” when they have no clue how the trials are conducted. It may have worked with a person or two but not everyone. DFMO’s effects turned out to be modest.
It’s an accepted and legitimate part of doing clinical trials — if the principle investigator can keep his meddling mitts off the data and if he bothered to recruit a sufficient number of study subjects to begin with, which unfortunately, is not the case in many instances.
Here's a helpful anology: You're waiting in line at a Wal Mart checkout. There are two old ladies with change purses out, and 3 fat ladies with food stamps and an assortment of old gift cards in their hands. The prognosis is that it will serve to double the time it takes you to progress in the line.
I take it to mean that it doubles the time it takes to progress from one stage of the disease to the next. Or from stage one to end stage. Or something similar.
Which is a good thing, IF the effect is real and not imagined. Often it’s the latter, imagined by an overly enthusiastic principle investigator who has stars in his eyes and has been meddling with the data and abusing his poor statistician since the day he hired him, if he ever even bothered to hire one.
A good friend of mine died from it also.
OK, so here’s your choicea.
Lose (not even proven yet) a bit of your hearing.
Need I ask?
Same deal with the EDTA Chelation studies. Started around 2001. Supposed to be a seven or ten year study, whatever.
Latest I hear is it’s still going on, any release of initial results are being delayed yada yada yada even though EDTA has been KNOWN to be an effective treatment for some forms of heart problems since like NINETEEN TWENTY OR SO...!!!
>>Lose (not even proven yet) a bit of your hearing.<<
No, everyone who took it lost their hearing.
And it only had modest success.
Seriously, we were fighting when this was going on. It was a false hope by the press.
Easy choice, and it should be mine to make...
But I do hope it is too late for Chavez.
THAT trial has stopped due to efficacy. If you read the article, the drug was approved last year. This study looked at the use of zytiga in conjunction with a steroid therapy for men with metastasized prostate cancer who haven’t had chemo treatment.
The combination proved so successful stopping the trial was the ethical thing to do. You don’t watch people die just to gather a bit more data. There will be other trials, designed differently, to make the case for this treatment.
Also, J&J couldn’t stop that trial without consulting the FDA. There was no “cherry picking”. Johnson & Johnson wouldn’t risk billions of dollars on trying to trick the FDA that their drug works.
“Relax. It will still be 15 years before its on the shelf.”
Seriously, did ANYONE actually read the article? Sheesh!
And what I gather from your comments about evil “Big Pharma” I see you make similar judgments about things equally uninformed.
What do you call Kyle’s Dad? Flipper!
To further the analogy:
When all five decide to pay by Check, that’s the Gov’t getting involved.
You know, if you say things like “You dont watch people die just to gather a bit more data,” you’ll never be a Czar in the current administration.