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Oleander proven ineffective for cancer - Printable Version

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Oleander proven ineffective for cancer - James - 07-02-2012 12:50 AM

I recently saw someone writing about oleander extract as a treatment for cancer. The article was about oleander extract passing phase 1 FDA trials. But the author claims that it can "apparently can be effective against a wide variety of cancers" according to the study. Why is this claim a problem? Well first of all phase 1 studies have NOTHING to do with testing effectiveness of a compound. Phase 1 testing is to determine safety of dosing. Secondly, if the author would have actually read the study then he would have found that the effects were minimal. The author claims "7 of the 46 trial participants had their cancers stabilized for 4 or more months". To start with "stabilized" does not mean cured and thus does not mean effective. You can stabilize a fractured leg but this does not mean the fracture is healed and you can go running. So this was a very misleading statement.

There were also side effects to contend with:


http://www.asco.org/ASCOv2/Meetings/Abst...ctID=80984

This second abstract though is more telling:

http://meeting.ascopubs.org/cgi/content/...7/15S/3537

First of all it shows the author's conflicts of interest with stock ownership, research funding and advisory role.

But the most important part of this abstract is this statement "Of the 15 evaluable pts, 3 had stable disease for > 4 months, with bladder, colorectal, and fallopian tube cancer pts having an 11, 16, and 10% reduction by RECIST respectively. "

"RECIST" means Response Evaluation Criteria In Solid Tumors. This simply is a set of standards by which it is determined if a patient gets better, worse or remains stable during the course of treatment. This is primarily by the measurement of tumor size. One problem that has been reported with RECIST though is that there is no standard for how measurements are done, which has called the whole RECIST program in to question.

Let's assume though that there was a standardization. If we look at the improvements they are not that impressive. Over a 4 month period there was only between a 10-16% reduction of tumor size in the three evaluable patients. To start with a 10-16% reduction in tumor size over 4 months is nothing really. Many chemotherapy drugs have a better track record than that, and many people such as myself consider chemotherapy to be quackery based on their low success rates. The other major question is why were there only three "evaluable patients" out of the whole study? And what made them "evaluable"? Were these the only patients that had any kind of positive response?

There is another statement in the study that really bothers me though. First they state "To date 15 pts have received PBI-05204" (oleander extract). So they claim 15 patients to date have received the oleander extract, but then state "Of the 15 evaluable pts". If there were only 15 patients to begin with then why are they stating "of the 15 evaluable patients"? To me this would imply that there were more than 15 patients to begin with since there were only 15 that were evaluable. So is this another case where patients are being dropped from studies if they die or do not respond to make the drugs appear effective? In fact, if you look at both studies they both claim to be about the first phase 1 trials of PBI-05204, but the one abstract shows 15 participants while the other shows 46 participants.

Regardless, the results were not as impressive as were being portrayed showing how easy it is to misinterpret findings to mislead the public on the effectiveness of a product. The above also shows how easy it is to manipulate the findings, especially when conflicts of interest are present.