The Health Plus Letter
August 22, 2006, Vol. 4, No. 17
By Larry Trivieri, Jr. – founder & publisher,
http://www.1healthyworld.com
If you prefer to read this issue online, you can read it, along with all other back issues, at http://www.1healthyworld.com/ezine.
Table Of Contents
New This Issue
Quote of the Day
Fast Fact
The FDA Says Viruses Are Safe as Food Additives
The FDA Claims Victory in Latest Ephedra Ban
The FDA Overrules Its Own Advisory Panel to Approve Worthless Cancer Drug
The Unspreadable Epidemic by Doug Casey
Recommendations
Reader Feedback
Medical F/r/e/edom
New This Issue
Welcome to another issue of The Health Plus Letter. In this issue I’ve decided to take the the Food and Drug Administration (FDA) to task for its consistent pattern of cronyism with Big Pharma and its hypocrisy regarding its mission to safeguard our health. Below you will find information about three recent FDA activities that once again reveal why I believe it ought to be banished. And I’m also sharing Doug Casey’s astute criticism of Big Pharma’s latest attempt to pro/fit from the bird flu scare, which is about as serious as the bogey man hiding under a child’s bed.
As always, please continue to send me your comments and suggestions. And please spread the word about The Health Plus Letter by passing it along to your friends and inviting them to subscribe.
Quote Of The Day
“I have not failed. I’ve just found 10,000 ways that don’t work.”
-- Thomas Edison
Fast Fact
The Food and Drug Administration recently approved viruses as a food additive.
(For more on this, see below.)
Unabashed Plug
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The FDA Says Viruses Are Safe as Food Additives
File this under, You can’t make this stuff up. The FDA recently approved the use of a mix of viruses known as bacteriophages as a spray to protect cold cuts, hot dogs, sausages, and lunch meat (including chicken and turkey) from bacteria. According to the FDA, “As long as [the viruses are] used in accordance with the regulations, we have concluded it's safe.” Uh huh.
Also according to the FDA, consumers won't be aware that meat and poultry products have been treated with the spray. Lovely!
But don’t worry, because, “The FDA is applying one of the toughest food-safety standards which they have to find this is safe,”said Caroline Smith DeWaal, director of food safety for the Center for Science in the Public Interest, a consumer advocacy group. "They couldn't approve this product if they had questions about its safety."
To which I can only add, Smith DeWaal is either woefully naïve and ignorant of the fact that the FDA has a long history of approving unsafe drugs, or willfully choosing to ignore this fact as she serves as an FDA cheerleader.
Sandwich, anyone?
Unabashed Plug
The Acid-Alkaline Food Guide, which I co-wrote with acclaimed health expert Dr. Susan Brown, is n.o.w available. In addition to being available at your local bookstore, you can also find it at Amazon.com, www.bn.com (Barnes and Noble online), and various other online bookstores. I highly recommend that you purchase it and put it to good use.
The FDA Claims Victory in Latest Ephedra Ban
Yesterday (August 21, 2006), the Food and Drug Administration issued the following press release:
<<FDA Statement on Tenth Circuit’s Ruling to Uphold FDADecision Banning Dietary Supplements ContainingEphedrine Alkaloids
Background: On Aug. 17, the U.S. Court of Appeals for the Tenth Circuit in Denver upheld the Food and Drug Administration's (FDA) final rule declaring all dietary supplements containing ephedrine alkaloids adulterated, and therefore illegal for marketing in the United States, reversing a decision by the District Court of Utah.
The Tenth Circuit Court of Appeals' ruling demonstrates the soundness of FDA's decision to ban dietary supplements containing ephedrine alkaloids, consistent with the Dietary Supplement Health and Education Act (DSHEA) of 1994. The Tenth Circuit Court of Appeals also found that Congress clearly required FDA to conduct a risk-benefit analysis under DSHEA.
FDA conducted an exhaustive and highly resource-intensive evaluation of the relevant scientific data evidence on ephedrine alkaloids before issuing its final rule, which became effective in 2004. The court found that the 133,000-page administrative record compiled by FDA supports the agency's findings that dietary supplements containing ephedrine alkaloids pose an unreasonable risk of illness or injury to users, especially those suffering from heart disease and high blood pressure.
No dosage of dietary supplements containing ephedrine alkaloids is safe and the sale of these products in the United States is illegal and subject to FDA enforcement action.>>
Commentary: Well, golly gee, isn’t this great? Not hardly! The key sentence in the above press release is this one: “The court found that the 133,000-page administrative record compiled by FDA supports the agency's findings that dietary supplements containing ephedrine alkaloids pose an unreasonable risk of illness or injury to users, especially those suffering from heart disease and high blood pressure.”
One the surface, this looks like the FDA compiled definitive proof that ephedrine alkaloids truly are dangerous, despite the fact that ephedra, a natural herb in which they are contained, has been safely used for literally thousands of years by traditional herbalists and practitioners of traditional Chinese medicine. But take a closer look at what the statement actually says—all that the court relied on it making its ruling was the FDA’s administrative record. Who cares if such record is 133,000 pages long? The ques/tions to ask are: 1) Why didn’t the court ask for and rely upon actually scientific data (something an administrative report, no matter how long, is not)? More importantly, 2) If ephedrine alkaloids are so safe, why does the FDA permit synthetic versions of same (epinephrine) to be used in over-the-counter cold and cough medicine? (Answer: The synthetic versions are manufactured by drug companies?) And, 3) how does the FDA define “unreasonable risk of illness or injury” to users of dietary supplements that contain ephedrine alkaloids?
According to the FDA, 153 people died because they used ephedra wei.ght-loss products. Not in a single year, but overall. Analysis of these 153 reported fatalities, however, reveals that no conclusive evidence establishes that ephedra was the primary cause of death. That aside, what I want to know is how the FDA defines “unreasonable risk of illness or injury” when it comes to the pharmaceutical drugs they approve, which cause more than 100,000 deaths in the U.S., result in over 2 million hospitalizations, and cause injury to an estimated 10-20 million other people each and every year, when they are properly prescribed. Clearly the FDA uses a different standard when it comes to evaluating the safety of pharmaceutical drugs compared to the one they use to evaluate dietary supplements. Equal clear is that the FDA’s campaign against natural ephedra products is little more than an attempt by the FDA to overthrow DSHEA. Given that the Tenth Circuit’s ruling is based on no discernible science, that overthrow may yet occur, especially n.o.w that the mainstream media is starting to trip over itself to proclaim the ruling to be a great victory for health safety and cause to re-examine DSHEA blah blah blah.
For the last word on this subject, here’s the perspective of Alan E. Shugarman, M.S., R.D., of Discovery Nutrition, Inc., who wrote: “Politics over science. It is truly a sad day for those of us educated about this topic and [who] believe in scientific evidence over political pressure. When used responsibly, according to label instructions, ephedra is very useful for suppressing appetite and helping people who are attempting to lo.se wei.ght (which is why it sold so well). However, as with many products on the market (and I am not just talking about supplements), when used against label recommendations they can cause problems. Maybe we should just ban everything that, if used improperly against label recommendations, can cause injury or death. One wonders what supplement will be next to fall to this kind of political pressure. Can you say DHEA, Creatine, or maybe Vitamin C? After all, you can get terrible diarrhea from high dose Vitamin C, which can cause severe dehydration, electrolyte imbalance, and a possible heart arrhythmia.....what a sad day indeed....”
The FDA Overrules Its Own Advisory Panel to Approve Worthless Cancer Drug
As further proof of just how craven the FDA is when it comes to protecting and promoting the financial interests of Big Pharma, consider this story: According to noted cancer researcher Ralph Moss, “The Food and Drug Administration (FDA) has taken the rare step of overruling one of its own advisory panels and has approved the drug Gemzar (known generically as gemcitabine) for the treatment of recurrent ovarian cancer, even though in clinical trials it failed to improve survival in patients with this disease.” [Emphasis added, and I disagree with Dr. Moss that this is a “rare step.” It’s actually “business-as-usual.” – LT]
Dr. Moss continues: “The randomized clinical trial (RCT), gold standard of testing since the post-World War II era, is n.o.w imperiled as ne/ver before in America. What we are witnessing is the deliberate eclipsing of survival as the primary standard of benefit in drug testing, and a triumph of the "surrogate marker" – a substitute measure that is typically unrelated to survival.”
To read Dr. Moss’s full report on this subject, please visit his website at: http://www.cancerdecisions.com/082006.html.
Since Gemzar failed to improve patient survival rates, it’s basically worthless. So why did the FDA approved its use, to the point where it even overruled its panel of advisors who investigated Gemzar? I think by n.o.w it’s obvious that there is no legit.imate explanation that the FDA can provide to defend its decision. But you be sure that Gemzar’s manufacturer, Eli Lily, is laughing all the way to the bank.
Note: In my criticisms of the FDA, I wish to point out that I am targeting its administrative branch, not its scientists, many of whom I suspect are very competent, decent people. Though increasing conflicts of interests between Big Pharma and physicians and medical researchers have come to light in the past few years, the most obvious and insupportable conflict of interest between Big Pharma and the FDA and other federal health agencies is to be found at the administrative level.
Unabashed Plug
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The Unspreadable Epidemic by Shannara Johnson
[The following article first appeared in What We Know N.o.w, a f/r/e/e online newsletter published by Doug Casey. (For more information, visit http://www.caseyresearch.com/publications.php.) Shannara Johnson is its managing editor and an investigative journalist with more than 20 years experience. I’ve emphasized certain of the points she makes in italics. As you read this article, ask yourself if you’ve seen any of the recent scientific research Johnson cites reported in the mainstream U.S. media. I certainly have not, meaning that the bird flu bogeyman continues to hold sway over most Americans. Also note the inherent futility of flu vaccines in general.]
Just a few weeks ago, British pharma giant GlaxoSmithKline proudly announced a major breakthrough in creating a new bird flu vaccine. The product—unlike competitor Sanofi’s vaccine—only contains low doses of the active ingredient and is therefore better suited for mass production. The vaccine is said to have been proven effective in clinical trials and GSK is eyeing market introduction for 2007.
Reason to celebrate, or just a marketing ploy by the pharmaceutical industry?
First of all, remember that flu vaccines work—or are supposed to be working—by injecting small amounts of the same virus strain that goes around, thereby triggering the body’s immune system and creating antibodies that prevent infection.
Critics of the annually distributed flu shots have repeatedly pointed out that those vaccines do more harm than good, simply because they’re manufactured using last year’s virus strains. As soon as “this year’s flu” spreads, the bodies of the inoculated n.o.w have to fight two different viruses instead of one, making recovery even harder.
The logical gap he/re is obvious: How can GSK, or anyone else, create a vaccine n.o.w for a virus that hasn’t even mutated? Since it is impossible for them today to have the virus of tomorrow—unless they own a time machine—such a vaccine has to be, by definition, mostly worthless.
According to GlaxoSmithKline, “the vaccine provoked a strong immune response in more than 80 percent of the people tested.” Which is a pretty nebulous statement, if you think about it. It only means that the test subjects’ bodies responded to being infected with a virus, period.
In 2005, a hopeful Russian vaccine maker was getting a damper when, according to Radio Fr/ee Europe/Radio Liberty, “EU officials. . . insisted that a useful bird-flu vaccine could only be created once H5N1 mutates into a strain that spreads between humans. They say such a virus could be very different from the current strain.”
How is the current situation any different? It isn’t. Only those were “just the Russians,” and this is GlaxoSmithKline, with a lot more clout, propaganda power, and the mass media behind it to tout its “great breakthrough.”
But aside from those musings, recent scientific findings indicate that a bird flu pandemic may ne/ver happen in the first place. [Something I’ve been saying from the start of the bird flu scare – LT]
So far H5N1, the bird flu virus, has proven virtually incapable to spread between humans. “One study suggested that two proteins on the surface of H5N1 allow it to attach to and infect bird cells, but are ineffective at attaching to human cells,” reported the UK Science and Development Network in an August 3 article. “This led researchers to suggest that H5N1 might need surface proteins more like those on human flu to trigger a pandemic.”
A team of scientists from the U.S. Centers for Disease Control and Prevention (CDC) put this theory to the test, creating different combinations of H5N1 samples from Hong Kong, Indonesia and Vietnam and the human flu virus H3N2. They tested the viruses’ ability to replicate and transmit in ferrets, whose respiratory tract cells act similar enough to humans’ to gain viable evidence.
The results: “One virus had human flu proteins on its outer surface, but bird flu genes inside. Although it was good at replicating, it was poor at spreading from ferret to ferret,” SciDev stated. “A virus with H5N1 external proteins and internal human-flu genes replicated as much as human flu virus, but could not spread between ferrets at all.”
Even though the authors of the study conceded that they hadn’t looked at every possible combination of human and H5N1 viruses, those findings seem, if not conclusive, to be at least a major clue.
Just a few months earlier, researcher Thijs Kuiken of the Erasmus Medical Center in the Netherlands found that the bird flu virus is rarely able to attach to cells in the upper respiratory tract because it is commonly trapped by mucus and expelled before it can replicate. The only cells H5N1 could easily attach to are located in the human lungs—autopsies of bird flu victims found H5N1 deep in the lung tissue—and very seldom they can get that far.
Then what about the Indonesian family that made headlines in May because seven of its members died of avian flu—so far the largest cluster of fatalities? After thoroughly studying the situation, the WHO finally concluded that the inexplicable contamination took place only within that family, and that there is no evidence the virus has mutated to allow easy human-to-human transmission.
Of course that doesn’t mean it’s impossible that this might happen. But the threat to global public health definitely seems much smaller than feared. Until an actual outbreak occurs, we are inclined to remain skeptics.
Copyright © 2006 by Casey Research, Inc. All Rights Reserved.
Unabashed Plug
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Medical F/r/e/edom
Please contact and support the following organizations dedicated to protecting our health freedoms.
Citizens for Health - http://www.citizens.org
Alliance for Natural Health – http://www.alliance-natural-health.org (The leading organization fighting to preserve health f/r/e/edom in England and the EU.)
Institute for Health F/r/e/edom – http://www.ForHealthF/r/e/edom.org
International Advocates for Health F/r/e/edom (IAHF) – http://www.iahf.com
And to learn how corrupt and extensive Big Pharma’s monopoly is, visit http://www.pnc.com.au/~cafmr/online/research/index.html the website for the Campaign Against Fraudulent Medical Research. In particular, read their in-depth report The Pharmaceutical Drug Racket that you will find th/e/re.
That’s all for this week.
Health and Blessings!
Larry Trivieri, Jr. (larry@1healthyworld.com)
Disclaimer: The Health Plus Letter is a weekly eZine published by Larry Trivieri, Jr. and Library of Health, LLC (dba www.1healthyworld.com) 1514 Genesee Street, Suite 52, Utica, NY 13502. It is made available without charge for info/rmation purposes only and is not intended as a substitute for medical care. If you are experiencing a health problem, seek prompt medical attention.
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