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To: LibWhacker

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?


4 posted on 06/03/2012 12:55:37 AM PDT by agere_contra
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To: agere_contra

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.


5 posted on 06/03/2012 1:16:55 AM PDT by onona (So long Doc Watson, you were an inspiration.)
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To: agere_contra
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?

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.

6 posted on 06/03/2012 1:34:25 AM PDT by cva66snipe (Two Choices left for U.S. One Nation Under GOD or One Nation Under Judgment? Which one say ye?)
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To: agere_contra
>"what if the drug causes horrific side effects that don’t manifest in a truncated trial?"

Apparently you haven't watched TV in the last decade.

You call Kyles dad.

9 posted on 06/03/2012 3:32:09 AM PDT by rawcatslyentist ("Behold, I am against you, O arrogant one," Jeremiah 50:31)
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To: agere_contra

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.


13 posted on 06/03/2012 4:56:11 AM PDT by LibWhacker
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To: agere_contra

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.


21 posted on 06/03/2012 6:57:24 AM PDT by brewer1516
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