A review of allopathic and holistic products, devices and therapies.

I saw a post on Curezone about oleander extract as a treatment for cancer.  The post was about oleander extract passing phase 1 FDA trials.  But the author, Tony Isaacs, claims that according to the study oleander “apparently can be effective against a wide variety of cancers”.  Why is this claim a problem?  Simple, this is not what the study determined.

One of the cardiac glycosides in oleander, oleandrin, was found to inhibit a few cancer cell lines in culture.  Just because something has an effect in culture though does not mean it has the same effect in the body.  Vitamin C can kill semen cells in culture.  Yet it does not do this when consumed. If it did none of us would have ever been born.  This is why animal and eventually human studies are conducted.  So far the actual human studies have shown oleander extracts to be a failure in the treatment of cancer.

Mr. Isaacs implied the therapy was effective because “7 of the 46 trial participants had their cancers stabilized for 4 or more months”.   “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 more cases of potentially serious side effects than there were “stabilized cancers”.  These included proteinuria in 8 trial participants and cardiac (heart) abnormalities in 10 trial participants:

http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=80984

Stabilization of only 7 of 46 cancers for 4 months is not a good track record by any means, especially when all the trial participants had to be in the earliest stages of cancer.:

http://clinicaltrials.gov/ct/show/NCT00554268?order=107

Inclusion Criteria:

  1. Participants must have an ECOG performance status score of 0-1”

See explanation of ECOG score here:

http://www.ecog.org/general/perf_stat.html

And without long term follow up it is impossible to say if the extract had any success in eliminating any of the 7 cancers or if each of these 7 trial participants still succumbed to their cancers.

So how can Mr. Isaacs honestly claim that oleander extract was “effective against a wide range of cancers” when there is absolutely no evidence to back this claim?  And how does Mr. Isaacs come to conclusion “a wide range of cancers”?  Of the 7 trial participants, all of which had early stage cancers, there were only 6 forms of cancer showing at least a temporary stabilization.  With hundreds of different types of cancer six is hardly a “wide range”.  And “effective” is impossible to say without long term follow up.  Therefore, the initial claim is not fact, it is merely more hype.

The first report on this study only showed 15 early stage cancer trial participants, not 46.  Out of these 15 trial participants only 3 had stabilized cancers for 4 months or more.:

http://meeting.ascopubs.org/cgi/content/abstract/27/15S/3537

This brings up an interesting point.  This first report was written in 2009 and the final report in 2011.  Therefore, the researchers had 2 years before their final report, which means they could have done a 2 year follow up on the original 3 trial participants to see if their cancers were still stabilized, or if the participants succumbed to their cancers.

This was never done though.  Instead all future participants, who also had to be in early stages of cancer, were also evaluated on the 4 month stabilization criteria based on RECIST as shown by the abstract:

“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 of an early stage cancer 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.

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?

This is a common tactic of pharmaceutical companies, especially when testing chemotherapy drugs.  If a test subject dies or does not respond to the drug the test subject is dropped from the study so the failure will not skew the test results towards the negative.  This makes the ineffective drug “appear” effective.  I first saw this tactic reported by a couple of doctors in the Journal of the American Medical Association (JAMA) over 20 years ago.

Regardless, the results were not as impressive as were being portrayed by Mr. Isaacs.  Out of the 46 trial participants only 7 of the trial participants had a stable disease equal to or greater than 4 months.  This means that virtually all the participants had no benefit from the drug whatsoever.  Of the small number of participants that appeared to have some benefit there is no long term follow ups given.  If the cancers became unstabilized at 5 months they can still list the cancers were stable for 4 months or more, even if the participant still dies from the cancer.

Cancers do tend to come back within a few years with most therapies.  This is why cancers are not considered cured until the person reaches the 5 year mark cancer free.  Using such a short time duration of 4 months of stability can make a therapy appear more effective than it really is.  This would be like claiming someone who goes in to remission from chemotherapy for 4 or more months is cured of their cancer even if the cancer comes back later and kills the person.

In my opinion MD Anderson Cancer Center should have held off until the expected completion date of 2014 to write their “final report” so they could have included long term results instead of short term results only.

The claims made about oleander being effective shows how easy it is to misinterpret or misrepresent findings to mislead the public on the effectiveness of a product.

 

For related information see:

http://medreview.wordpress.com/2012/10/15/is-oleander-soup-for-cancer-a-scam-part-1/

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