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October 17, 2007

Who is the FDA Protecting?
Opinion

A few days ago, SweetRemedy.tv linked to an article detailing the FDA
seizure of $71,000.00 in supplements from FulLife Natural Options Inc..
The FDA's justification for this muscle-flexing was that, "The agency
takes seriously its responsibility to protect Americans from unapproved
drugs." On the very same day, another article appeared recommending
that women make their own informed decisions about whether or not to
have a mammography. The main reason cited for this idea was that there
are many "false positives" and over-diagnoses resulting in unnecessary
tests, treatments and anxiety, when mammograms, by the article's own
admission, only save (for every 1000 women screened) about one life in
younger women and 3 in older women. Given that the odds of benefiting
from mammography are much worse than the odds for a novice gambler of
winning a free hotel night in Vegas, it would seem reasonable to allow
women to make informed, intelligent decisions. I applaud the authors of
this recommendation for respecting the consumer enough to consider her
to be capable of making decisions when given the correct information.
Yet, a mammography is an FDA-approved procedure. Therefore, according to The FDA, mammographies must be safe and effective. This discriminating outcome in the approval process for  drugs or medical procedures favors the pharmaceutical companies with deep pocketbooks over the much cheaper herbal or natural treatments that would successfully compete with them. It seems to me that the FDA is more interested in protecting the pharmaceutical companies and their profits than protecting Americans.

Just look at the recent settlement that the court ordered Wyeth to pay
because three women said that the company's hormone therapy drugs caused
their breast cancers. It was ruled that Wyeth should pay $134.5 million
for their responsibility. Was this an FDA approved drug? Yes. It is
not apparent to me where the FDA is "protecting Americans" in this
situation. According to the article, "Wyeth lawyers said that the drugs
were not dangerous and were still on the market. They had been through
trials on breast cancer risk, carried detailed warning labels about the
risks, and had been approved by the US Food and Drug Administration
(FDA)." Yet, they were still found to be responsible and instructed by
the jury to pay.

On the cheaper side of treatment, there was also study from August of
this year published in the journal, Nutrition Reviews, by researchers at
the Moores Cancer Center at the University of California, San Diego.
Cedric F. Garland, Dr.P.H and colleagues found that sunshine cuts the
risk of breast cancer. In Sweet Remedy, Dr. Joseph Mercola states that
some 6000 people actually die each year because of lack of sunshine.
When I did a search for sunshine and breast cancer on The FDA from
August, the closest I found was the Patient Information for the drug,
Evista, which recommended supplementing with Calcium and Vitamin D, "if
you do not get enough calcium and vitamin D in your diet." There was no
other acknowledgement that I could find mentioning the positive effects
of vitamin D - let alone sunshine - on breast cancer. In other words,
The FDA essentially ignored the beneficial effects of sunshine (natural
vitamin D) on breast cancer risk. Is that because sunshine is "an FDA
unapproved drug"? Perhaps the sun should pay for some extensive tests.

References:

"$71,000 Worth Of Dietary Supplements Seized For Allegedly Violating New
Act, Says FDA", Medical News Today,
http://www.medicalnewstoday.com/articles/85412.php, Oct. 13, 2007

"Approximately $71,000 of Dietary Supplements Seized at FDA Request", US
Food and Drug Administration, www.fda.gov, October 13, 2007

"Patient Information, Evista", posted on www.fda.gov, September 10, 2007

Sweet Remedy: The World Reacts to an Adulterated Food Supply (DVD),
Tucson: Sound and Fury Productions, 2006.

Sweet Remedy Website, www.sweetremedy.tv

"Sunshine cuts risk of breast cancer", Scotsman,
http://news.scotsman.com/health.cfm?id=1224282007, August 5, 2007

"Study Shines More Light on Benefit of Vitamin D in Fighting Cancer,",
Science Daily,
http://www.sciencedaily.com/releases/2007/08/070821163248.htm

"Women Should Make Their Own Decision About Breast Screening", MedIndia,
http://www.medindia.com/news/Women-Should-Make-Their-Own-Decision-About-Breast-Screening-27834-1.htm,

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