.........................The Therapeutics Research Institute (TRI)...................

  The Therapeutics Research Institute — 

Health Research Newsletter

TRI   418 N. 38th Street    Omaha, NE  68131    Editor-in-Chief—Steven Evans    Vol. 10:  No. 11/12

 

What’s the Straight Scoop?

Some of our readers have written in, thinking there was a new study1 just completed showing vitamin E and selenium actually caused increased risk for cancer, particularly prostate cancer.  No, there was not a study just completed that showed that.  No it wasn’t run by Cleveland Clinic.  No the combination of E and selenium was not found to be dangerous.  Let me try to give you the actual facts, versus the spin story that ran from the New York Times to the Wall Street Journal and all in between.

 What actually happened was that some “researchers” took data from a 2004 study that did not find an increase in prostate cancer overall and extracted selected subsets of the data from it.  Some of these researchers work at Cleveland Clinic but the clinic did not sponsor any trial.  Many of the authors as revealed in the “Conflict of Interest” section received money from such pharmaceutical companies as Merck, Pfizer, Abbott, Amgen, etc.   Vitamin E and selenium in the 2004 study was shown to actually reduce all-cause mortality.   The spin doctors did not mention this. 

 Moreover the 2004 trial used synthetic E which has been repeatedly shown to be potentially dangerous. Before the 2004 study began, may researchers pleaded with the trial designers to use natural E, to no avail.  In a selected subset of the data, E alone increased prostate cancer a tiny amount, while selenium in a selected subset of the data increased prostate cancer an even smaller tiny amount.  Yet in the group that took both, this group did better than either the E or selenium alone groups.  If there were a danger, taking both should have been a worse outcome, not an improved outcome.  Essentially the combination group has effectively no increased risk.

 Now the media seemed also to forget that a study2 from the Nutrition Prevention of Cancer Study group showed that patients treated with 200 mcg of selenium had a 50% reduction in total cancer and a 37% reduction in total cancer incidence.  Another double-blind placebo-controlled trial3 showed that 200 mcg of selenium decreased the risk of prostate cancer by 63%.  Still another major study4 demonstrated a 32% reduction in prostate cancer with daily vitamin E supplements.  There are yet many more such reputable studies all showing the benefit of vitamin E and selenium for prostate cancer risk. 

 What is the point, then?  A dubious methodology spins data from an old study that did not find overall increased risk and purports to find a suddenly new discovery.  Their form of data analysis by the way is unusable for any FDA approval purposes – so if a major benefit had been found, it would then be declared unusable. 

 Keep in mind that your Formula #18, for those on the cancer prevention trial, receive the combination product of natural E and selenium which even the spin doctors could not indict.  In fact, even with all their spin, they found that the combination reduced risk of all-cause mortality by about .2%.  They also found E reduced the risk of serious cardiovascular disease by .7%.  But none of their headlines bothered to mention this – just the false assertion, “Vitamin E [with selenium} causes cancer!” 

 Now we must look at another recently highly touted study5, one purporting to show that, as the headlines everywhere read, “multi-vitamins increase your risk of earlier death.”  What was going on here?  The study was not a trial at all – the researchers used a questionnaire on 38,772 older women.    It was based on their recall of what they ate over an 18-year period, and they were surveyed only three times during that 18 year period, just relying on their memory of what they took. 

 Questionnaires just relying on the memory of the participants is generally considered to produce data next to worthless.  Then the researchers had virtually no control for underlying problems the participants might have had.  They admitted participants with hypertension and diabetes into the study for example, which will obviously bias the results.  We don’t know what if any prescription drugs these women might have also been on. 

 The study actually reported that taking supplements of B-complex, vitamins C, D, E and calcium and magnesium were associated with a lower risk of mortality.  This was conveniently omitted from the Abstract of the study’s report.  There was no determination of the amounts of vitamins taken.  Moreover most of the associations with mortality came from the use of iron and copper supplements which are known to be potentially inflammatory and toxic when taken by older people.

Now let’s look at one more study6.  Here we supposedly learned that multi-vitamins increased prostate cancer.  First, this was not a trial.  The assessment of multi-vitamin use was based on a self-administered, mailed food-frequency baseline questionnaire.  Let’s look at some details of this study.  Men who stated they did not know how much vitamin E they took were placed in the 400 IU every day category.  Men who reported taking even one multi-vitamin supplement a month were recorded as taking a multivitamin every single day. 

So for those who might have taken no more than 12 supplement servings per year, they were considered to have taken 365 a year.  In fact, the primary analysis from the study did not show evidence of risk of prostate cancer.  Only subgroup data selection produced an association.  But even here, none of the outcomes were in fact statistically significant [i.e., the outcomes could be by chance alone].  The authors in fact concluded, “... it is possible that the [only] positive association with heavy use of multi-vitamins ... was spurious ... and ... the increased risk ... may be due to ... diagnostic bias ...”  In fact, if you remove the men diagnosed with prostate cancer within the initial two years of the study period [i.e., eliminating those already with cancer], no association was found at all.

One would think, what reputable journal in the world would publish a mishmash of this sort?  Oh, never mind, the government’s journal for the National Cancer Institute published it.  Ah ...  I see.  By the way, as the hysterical headlines “Vitamins cause prostate cancer” swirled across the country, a number of noted department chiefs of Urology around the country observed in their interviews that this shows that men should really not elect any vitamins whatsoever until all these issues are fully resolved. 

So what your Editor wishes to convey is that the campaign to discredit any supplement use for not only cancer but other diseases as well is alive and well and proceeding with full steam.  Moreover you cannot possibly ascertain any truth from the popular media – those who wrote me that they “learned” that XYZ causes or increases cancer have just been caught in another scam. 

There are in this Editor’s opinion unconstrained efforts by the multi-hundreds of billions of dollars pharmaceutical cartel (coordinated with complicit government collaborators) to attack and eliminate any use of supplements for diseases.  If you are not aware of these efforts, you will taken to the cleaners yet again.  This Newsletter will try to be a beacon of neutral assessment and truth about what may or may not be useful for you. 

That is why we have no advertisers, charge no fees for it, have no sponsors, and provide it as a service by the non-profit and independent Therapeutics Research Institute.  As some readers do, if you wish a fair assessment of some health news story, you can email us (sevans@gsm-usa.com) to get as neutral and as balanced a view as we can provide.

Key Supplement for Breast Cancer

There was another key reason I provided the discussion above.  In this section, I will analyze a large number of studies related to a key supplement for those who have had breast cancer (and then later, prostate cancer as well).  What we will see is not all the studies were positive.  But the overall picture is becoming clear.

To begin, an important study7 showed a clinically significant protective effect against recurrence of breast cancer by taking the right dose of aspirin.  This was an observational study, tracking 4,164 nurses who were diagnosed with breast cancer from 1976 to 2002.  Those taking aspirin 2-5 times a week had a 64% lower risk of dying from the disease.  Those taking aspirin 6-7 days a week had a 71% lower risk compared to those not taking aspirin.    The 2-5 times a week group had a 60% reduced risk of a distant metastasis.    Those taking 6-7 aspirins per week had a 43% reduced risk for distant recurrence.  Now this is not all that surprising.  We know in test tube studies that aspirin inhibits breast cancer cell growth and decreases tumor cell invasiveness.  It also reverse immune suppression caused by radiation therapy.  Now the rest of the story.

An earlier study8 found that aspirin significantly decreased breast cancer risk by about 40%.  This study covered 32,505 women and lasted five years.  Another  study9 found low-dose aspirin 4 or more times a week over 10 years decreased breast cancer by about 35%.  Still another study10 compared data from 26,580 women who were already diagnosed with cancer.  Those who took aspirin regularly has a 20% lower risk and those taking aspirin 6 or more times a week had 29% less cancer incidence than those not taking any aspirin.  So you might think, the matter is simple and if you had breast cancer, you should be taking aspirin nearly daily.  But things are not that simple.

First, one large earlier study11 found that following 89,528 women did not show any benefit between the aspirin takers and non-takers.  A second negative study12 lowered cancer risk for colon cancer and prostate cancer but not breast cancer.  There were other well-designed negative studies as well.

Then researchers began to pool all the data from all the studies.  Now positive correlations were found again in these meta-analyses,    Perhaps one of the largest pooling13 of 38 studies including over 2.7 million women demonstrated a 13% reduced risk.  So what is going on with all these studies?  Well, nearly all of the studies except for the first I introduced attempted to see whether aspirin could prevent breast cancer.  The first one above attempted to see if aspirin could change the risk of recurrence or metastasis while nearly all the others looked to see if aspirin could prevent breast cancer.  We know there is a huge difference between protecting against breast cancer versus changing its course once you have it.

But things are still not perfect.  A  smaller study14 looked at aspirin and cancer recurrence and found no statistically significant relationship.  Bummer.  But when we look at this negative finding closer, we see this study had half the participants as the positive study and ran for 6 years compared to the first one running 26 years.  Another major negative study used only 100 mg of aspirin every other day.  Where significant positive results were obtained, the studies used an adult dose of 325 mg daily.

So unlike our multivitamin hysteria headlines [bouncing from one study and conclusion to the opposite next week], what might we conclude?  I suggest that we may conclude that there is a solid possibility that long-term use of an adult daily dose of aspirin for those who already had breast cancer but are now in remission is a very likely wise thing to do to help prevent recurrence and/or metastasis.

This is the same conclusion recently published in the British Journal of Cancer15 since the British are not as married to Big Pharmaceuticals as we are.  The authors stated, “recent epidemiological evidence, demonstrating regular aspirin use after a diagnosis of cancer improves outcomes, suggests that it may have a role in the adjuvant setting where the risk-benefit ratio will be different.”  That is, taking aspirin if you have had breast cancer [which is now in remission] is probably a very good idea.

Still, we have the problem with aspirin which we have documented before: between 2-3% of the population have a significant problem with it (stomach bleeds, etc.).    But there is a simple way around this.  Remember that aspirin was just a synthetic (patentable) drug constructed to use willow bark, which Bayer could not patent.  Going back to basics, we can use much safer standardized willow bark instead to gain this aspirin advantage.

Hence your Editor’s final recommendation is: if you did have breast cancer which is now in remission, add one capsule of willow bark daily.  Swanson has product #SWH148, $6.99 for a 500 mg capsule, 120 in the bottle.  So it will last you four months.  Swanson can be found on the web at www.swansonvitamins.com or call 800-437-4148.  We have no connection with Swanson at all.  Other good suppliers include Puritan’s Pride, LEF, and Vitacost.com

I should note that if you have breast cancer and it is not in remission, so it is currently active, then you should do something entirely different.  For a complete discussion, I have written a 150 page book describing in detail what you could elect to do.  The final copy will be issued in January but you may obtain a copy of the current draft [without charge] simply by emailing me [sevans@gsm-usa.com] and requesting it.  I will forward an emailed copy to you.

It is likely that aspirin’s effect on cancer prevention comes about because of its ability to block cyclooxygenase. That is, it is a Cox-2 inhibitor.  The curcumin in your Formula #18 impacts the very same pathway.  Green tea is another Cox-2 inhibitor, and it too is well represented in Formula #18.  So for those on Formula #18, you are already benefitting from this research, so the willow bark daily capsule is completely optional.

One last question: why has not the powers-that-be assessed this matter, why has your oncologist not considered these data, and why have you not likely heard about it before?  Are they waiting for the data to be perfect?  Could it be that the benefit is likely obtained at a cost of $1.75 per month?  Could  this strategy simply be too simple and cheap to be of concern to American medicine?

A Key Supplement for Prostate Cancer

Men, read the entire discussion above since for men who already have prostate cancer, some of the data specifically included benefits for prostate cancer as well.  In addition, breast and prostate cancer have similar mechanisms of action.  So if you have prostate cancer, I recommend you add one capsule of willow bark daily as described above, even if on the Formula #18 trial and/or you are taking other protocols as well.

 If You Take Blood Pressure Meds, Read This!

After following patients for more than five years, researchers found16 that patients who took at least one blood pressure lowering medication at bedtime were about one-third as likely to experience heart attack, stroke, or heart failure compared to patients who took their meds upon awakening. So take heed!

 Are You Taking a Statin Drug and Niacin?

Many cardiologists have prescribed high dose extended-release niacin for patients with prior heart disease who are already on statin drugs to further improve their cardiovascular health.  In a huge NIH clinical trial17 to see if it had any advantage, the trial was halted after 32 months since the combination did not reduce fatal or non-fatal heart attacks, strokes, hospitalizations, revascularizations, etc.  There was no clinical outcome gain whatsoever. 

 It is true that the high-dose extended release niacin increased good cholesterol and lowered triglycerides but this did not affect patient outcomes at all.  This is not surprising to your Editor since the myth about the role of cholesterol has been widely documented.  If you are taking statin drugs, what you should add is CoQ10 since at least it is true that the statins will deplete this critical enzyme from your body which will significantly increase your cardiovascular  risk.  Take 200-400 mg daily. The niacin is a no-show.

 Are All Oncology Centers Equal?

Oncology Centers are cookie-cutter equivalents, by and large. There is at least one exception: the Cancer Treatment Centers of America (CTCS).  These centers do all the usual chemo and radiation, etc.  However they add the most modest of alternative or supportive therapy such as nutrition, naturopathic strategies, acupuncture, etc. 

 So how do they match up with this modest addition?  In a comparison of advanced breast cancer patients, 88% at CTCS survived after one year compared to 60% of patients undergoing just conventional treatment, 63% survived versus 44% after two years, and 46% survived versus 32% after three years.  Roughly you have a nearly 50% better chance of survival with CTCS’s alternative health care support added to conventional care.

References

1.   JAMA 306(14):1549-1556, 2011.

2.   JAMA, 276(24):1957-63, Dec. 25, 1996.

3.   Br Journal of Urology, 81(5):730-4, May, 1998.

4.   J Natl Cancer Inst., 97(5):396-9, Mar 2005.

5.   Archives of Internal Medicine, Oct 11, 2011.

6.   J Natl Cancer Inst, 99(10):754-764, 2007.

7.  J of Clinical Oncology, 28(9):1467-72, Mar 2010.

8.   Oncology Rep., 6(1):71-3, Jan-Feb 1999.

9.   Breast Cancer Res Treat., 109(3):533-43, Jun 2008.

10. Breast Cancer Res Treat., 126(1):149-55, Feb 2011.

11. J Natl Cancer Inst., 88(14):988-93, Jul 17, 1996.

12.  J Natl Cancer Inst., 99(8):608-15, Apr 2007.

13.  J Natl Cancer Inst., 100(20):1439-47, Oct 15, 2008.

14.  Cancer Causes Control, 18(6):613-20, Aug 2007.

15.  Br J Cancer, Aug 16, 2011.2011.

16.  J Am Soc of Nephrology, 22(12):2313-21, Dec 2011.

17.  NEJM, Nov 15, 2011.

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Content is for informational purposes only and is not intended as specific medical advice, consultation, or instruction for individuals nor substitutes for professional medical advice. ©TRI  Omaha, NE 68131