Monday, March 22, 2010

Heal-thy self ...

 To simplify complications is the FIRST essential of success. (Click here) 

Sunday, 21 March 2010
It has now been seven years since the Journal of the National Cancer Institute asked, rhetorically, if pomegranate were "nature's power fruit." There have now been at least 30 scientific articles on the anticancer potential of pomegranate. One company, Pom Wonderful, has been spending some of its hard-earned money furthering research in this field. Their "reward" came February 23, 2010 when the US Food and Drug Administration (FDA) issued a scathing 10-page warning letter, declaring POM Wonderful juice to be an unproven "drug," and demanding that the company stop providing health information relating to pomegranate on the company Web site.

According to the warning letter, "FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act." To understand this, you have to follow FDA's reasoning process. Each bottle of POM Wonderful juice understandably gives the company's Web address, This Web site then cites various scientific studies that support the idea that pomegranate juice is a healthful beverage. According to FDA logic, this constitutes advertising. In regard to prostate cancer, the company states the following:

"In a clinical study involving 46 men with rising PSA after prostate cancer treatment (surgery or radiation) who consumed 8 ounces of POM Wonderful 100% Pomegranate Juice daily over two years, PSA doubling time increased from 15 to 54 months....PSA doubling time is an indicator of prostate cancer progression."

These are truthful statements, derived from a 2006 phase II clinical trial conducted at the University of California, Los Angeles (UCLA). There were 14 coauthors on this study, which was published in Clinical Cancer Research (Pantuck 2006).

But according to FDA, the mere act of citing a scientific study automatically constitutes a form of advertising and turns an innocuous and healthful drink into a drug. Why? "When scientific publications are used commercially by the seller of a product to promote the product to consumers," they say, "such publications may become evidence of the product's intended use....The citation implies treatment or prevention of a disease."

POM Wonderful is not just a drug, but a "misbranded drug." Why? Because, according to FDA, "POM Wonderful 100% Pomegranate Juice and POMx products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your products are that the labeling for these drugs fails to bear adequate directions for use."

In other words, a person with prostate cancer cannot possibly 'treat' his own cancer because he is not a medical practitioner. Pomegranate juice is intended for use by the general public. Therefore no adequate label could be written for it, since de facto no layperson could possibly understand or interpret such instructions.

 To simplify complications is the FIRST essential of success. (Click here) 

Truly, this whole situation with FDA has gotten out of hand. It would require the writings of a great satirist, such as a Jonathan Swift or a Kurt Vonnegut, to capture the absurdity of the situation. A harmless juice, which has already demonstrated some huge health benefits, is arbitrarily reclassified as a drug, and then declared "misbranded" because no patient (other than a medical doctor) is by definition allowed to treat cancer, even his own.

Meanwhile, FDA avoids a few larger problems that in a saner world might capture its attention. I could mention a couple of dozen of them, but will simply point out that E. coli bacteria are running rampant through the entire food supply. In November there was a recall of 546,000 pounds of contaminated ground beef in Connecticut, Maine and Massachusetts. This was only the tip of a huge iceberg of truly dangerous food products. But people who are trying to improve the health of the public are maligned and hampered by governmental agents.

--Ralph W. Moss, Ph.D.

 To simplify complications is the FIRST essential of success. (Click here) 

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