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Old 09-07-2012, 02:58 AM   #22
gdpawel
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Join Date: Aug 2006
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You bring up a perfect point about average population studies. Average population studies point to Herceptin being more effective than Tykerb, while in your case Tykerb seems to respond better. The reason so many patients suffer from chemotherapy is that treatment (based on those average population studies) usually follows a standard protocol and many patients have to try two or three kinds before one works (if any work), making them sicker in the process. Anti-cancer drugs should work best for you as an individual, not average patients from average population studies.

As increasing numbers and types of anti-cancer drugs are developed, oncologists become increasingly likely to misuse them in their practice. There is seldom a "standard" therapy which has been proven to be superior to any other therapy. When all studies are compared by meta-analysis, there is no difference. What may work for one cancer patient, may not work for another.

In a TheScientist.com article, "Crowdsourcing Drug Discovery," it was commented that for the last 50 years, randomized controlled trials have been the unquestioned gold standard, when in fact they have become a fiercely defended relic of our ignorance in 1962 when (US) Congress empowered the FDA to begin regulating efficacy.

At that time, it was a "best we could do" solution - but now? They take too long, cost too much, are fraught with unsolveable ethical problems that patients and many physicians dislike, and cannot ask the patient-specific molecular questions we now know need to be asked and answered.

Yet, most clinical trialists and the FDA cling to these crude, simplistic tools like an irrational safety blanket. If we can't reach agreement that clinical methodologies must adapt to new knowledge of the biology of disease, and that the way drug development is regulated must rapidly adapt in much the same way, then our ability to accelerate advances in medicine will remain stagnant.

A key point in this article is that the new system should be patient-centric. It has to be something patients will not only tolerate, or enter under duress, but rather a system that makes sense to them personally - even when they are not yet facing a serious or terminal condition. If real patients are left out of the process of change, we will likely end up in the wrong place again.

http://www.f1000scientist.com/article/display/57646/

I heard women who were bumped from the T-DM1 clinical trial because of disease progression, which meant that their cancer was growing despite the drug. Bumped off the trial because of disease progression? Wonder how many patients there were?

Response rates (how much a tumor decreased in size) can be inflated when excluding patients during clinical trials (evaluable patients). Patients not considered "evaluable" are often those who do not get the benefit of an entire treatment plan. The response rate is calculated after removing patients, who die or have been excluded, from the calculation. This inflates the response rate.

But clinical oncologists want to publish their papers. They need to report on the outcomes of their experiments, but if they had to wait for survival data, it could take years until all the data was aggregated. That wouldn't bode well for them to participate in pharma-sponsored trials in the future.

Response rates give clinical oncologists the opportunity to take a more optimistic look at therapies that have limited success. They can describe results as being complete remission, partial remission or simply clinical improvement.

If they treat all patients for three weeks, they can fairly evaluate the efficacy of a compound, which takes that lone (on average) before it can be regarded as effective. If they disregard all patients who die or were excluded after onset of therapy, and include only those treated three weeks or more, they can improve their data.

To justify their existence, they have to publish papers. That's what they do.
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