GlaxoSmithKline Petitions the FDA

GlaxoSmithKline Petitions the FDA

Date: 6/9/2008
Posted By: Jon Barron

On April 17th, GlaxoSmithKline, along with three organizations that it financially supports (funny how that works), the American Dietetic Association, The Obesity Society, and Shaping America's Health, submitted a citizen petition to the Food and Drug Administration asking them to prohibit weight-loss structure/function claims associated with any dietary supplements that promote a connection with weight loss unless those supplements were pre-approved by the FDA. This ban would apply to all product labels, websites, literature, and any marketing material. But the petition didn't stop there. It seems that not only did GSK want to prevent nutrition companies from stating that their product could help with weight loss, the petition also asked the FDA to prohibit claims for energy expenditure, modulation of carbohydrate metabolism, increased satiety or suppression of appetite, increased fat oxidation or reduced fat synthesis, and blockage of fat absorption. What impact would this petition have if approved? Quite simply, if you cannot understand how a nutritional product can help you because no one is allowed to tell you what the product does, then why would you buy it? Instead, you would be "forced" to buy the pharmaceutical version that very clearly states that it helps with weight loss, while less clearly listing the side effects...in much smaller print. If approved, in a single stroke, all natural alternatives to weight loss would be eliminated from the market. As an interesting side note, it should be mentioned that the organizations' signatories included a lobbyist, a person who helped get obesity classified as a disease, and a fundraising guru. Although unlikely to be approved at this time, it represents frightening upping of the ante in the conflict between traditional medicine and alternative health care.

Back in 2003, I wrote a newsletter entitled, " Don't Look at the Pinstripes." Of all the newsletters I've ever written, it's one of my personal favorites. It's also one of the least understood. The basic theme of the newsletter was borrowed from the Steven Spielberg film, Catch Me If You Can, in which one of the characters says that the New York Yankees won all their pennants not because they had better players, but because their opponents couldn't take their eyes off the pinstripes in the Yankee uniforms -- like a magician keeping your eyes busy with one hand, while palming a card with the other. The newsletter then proposed that this was a metaphor for what government regulators do in collusion with the medical community and the pharmaceutical industry -- keeping the alternative health community busy fighting major legislative initiatives (looking at pinstripes), while relentlessly picking the community's pockets clean, ex parte -- under the radar, and with no legislative approval required.

You would think that this was an easy concept to understand. It isn't. So once again, the alternative health community has allowed itself to become preoccupied by grandiose initiatives such as Codex, and totally ignored one of the biggest thefts of the century going on right now -- a theft so profound, it could easily trump every other issue out there. And for the most part, only a handful of industry pundits and organizations such as the National Health Federation seem to have noticed. The implications of this petition are profound and far reaching and will be devastating to your ability to access nutraceuticals and herbal supplements -- if allowed to continue. Fortunately, you can help stop it.

GlaxoSmithKline Petitions the FDA

The FDA's longstanding position has been that weight loss claims are permissible structure/function claims because being overweight is not a medical condition. However, the petition seeks to reclassify weight loss health claims as disease claims and urges the FDA to change its position on the grounds that:

1. Recent evidence establishes that being overweight is a risk factor for disease
2. Consumers believe that there is a relationship between weight loss and a reduction of risk of disease
3. Claims that a product will reduce a risk factor for disease are disease claims
4. The use of ineffective therapies can divert consumers from safe and effective therapies such as GSK's weight loss drug alli ™.
5. Manufacturers of weight loss supplements should be forced to substantiate their claims through health claim petitions before going to market.

Before moving on, let's deal with these five points.

1. Yes, it is absolutely true that recent evidence establishes being overweight as a risk factor for disease. But I wonder why GSK didn't petition the FDA to regulate the fast food industry to directly impact the level of obesity in the world today. Oh, of course, I forgot for a moment. There's no money in it, whereas alli is the only weight loss product that is actually already "approved" by the FDA.
2. Yes, consumers believe there is a relationship between weight loss and a reduction in the risk of disease; but if we follow this logic to its illogical conclusion, then anything the public comes to believe (no matter how they came to believe it) would be reason for goverment regulators to intervene in the sale of that product. As an amusing side note, look who currently helps "educate" the public that there is a connection between losing weight and a reduction in the risk of disease. http://www.gsk.com/infocus/obesity.htm. Talk about having your cake and eating it too!
3. Excuse me! GSK is trying to say that claims that a product will reduce a risk factor for disease are the same as disease claims? That's preposterous. New research, released as recently as just a couple of days ago found that eating a Mediterranean Diet, reduces the risk of Type I diabetes. According to GSK's logic, the Mediterranean diet would now fall under FDA guidelines and could no longer be promoted publicly as providing health benefits. Perhaps GSK is preparing to publish an "approved" diet book in the next few months. Well, if not a book, at least a diet plan. Oh my gosh! They are! http://www.myalli.com/whatstheplan.aspx.
4. Absolutely, the use of ineffective therapies can "divert" consumers. And I'm sure, it was just an oversight that the petition didn't mention that recent research now shows that cholesterol lowering drugs such as GSK's Mevacor probably do more harm than good -- thereby distracting consumers from more beneficial (and safer) natural alternatives. (But that would take business away from GSK.)
5. Hmm! I wonder what manufacturers have submitted such disease claim petitions for weight loss so they could take advantage of a favorable decision on the petition? Oh, silly me. At this point in time, GSK's alli™ is the only FDA approved, over-the-counter weight loss product. Thank goodness the FDA approved it, though. It works so well and has such "interesting" side-effects! How clever of GSK to get it approved.

The bottom line is that GSK says weight-loss dietary supplements don't work and that obesity and the secondary diseases like diabetes, cancer, and cardiovascular problems it is linked with are too serious a matter for dietary supplements to be making claims (not about the diseases, but about weight loss in general) without pre-market, pharma-style, disease claim approval.

All sarcasm aside, GSK's petition is well-written, even if based on faulty logic, and will find much support within the FDA's bureaucracy. In fact, it's in perfect alignment with the revised labeling guidelines the FDA introduced just last year. GSK's petition specifically address a number of weight loss alternatives currently available, from hoodia to bitter orange, and states, "There is no credible scientific evidence that would support any type of a claim accompanying a weight loss supplement." And then for added measure says that in those cases where there are indeed such studies, the studies are not rigorous enough or numerous enough, and therefore should be discounted. How convenient!

The FDA's decision making process on the petition will run to the end of October -- approximately. Right now, the odds are probably about 60:40 the FDA will deny the petition. Certainly every fiber of their being would love to grant it, but the fear that they might be overstepping their bounds, that a public suddenly denied access to their favorite weight loss products might scream in rage and cause their legislators to publically reverse an FDA decision is probably enough to hold them in check -- this time.

GlaxoSmithKline

But enough of the petition for a moment. Since GSK has decided to open a can of whoop-ass on the alternative health industry, I believe it is only fair to take a look at this company and get a sense of what might be motivating their petition -- other than concern for the public's health, that is.

Does GSK sell potentially risky products?

According to a major study conducted in the United States, Europe and Australia, patients who take the widely prescribed AIDS drug abacavir, manufactured by GSK, run nearly double the risk of heart attack compared with those who take other antiviral medications. The study, led by researchers at the University of Copenhagen, sifted through data from more than 33,000 patients starting in 1999. It found that the risk of heart attack rose nearly 90 percent for those prescribed abacavir. John Pottage, a vice president for GlaxoSmithKline, called the results "provocative." (At the very least, I would say.) The FDA made clear that although they are reviewing the data, they are not advising doctors to stop prescribing abacavir at this time.

A 2007 study found that GSK's diabetes drug Avandia increased the risk of heart attacks by 43% and death from cardiovascular events by possibly 64%. By coincidence, the study's author was then savagely assaulted. As reported in Counterpunch, a coordinated attack on the study's author, Dr. Steven Nissen, began appearing simultaneously in media all around the world. According to CounterPunch, "More than one story from ostensibly different sources derisively referred to Dr. Nissen as 'St Steven, the Patron Saint of Drug Safety', and 'Saint Steven the Pure'."

Among Dr. Nissen's attackers was FDA spokesman Douglas Arbesfeld. Coincidentally, Mr. Arbesfeld previously worked at the PR firm MS&L, where one of his clients was -- you guessed it -- GlaxoSmithKline. Former FDA Deputy Commissioner Dr. Scott Gottlieb, also connected with MS&L and GSK, ridiculed Nissen in a Wall Street Journal editorial. "Two more members of FDA's alumni, Peter Pitts and Robert Goldberg took another swipe at Dr. Nissen in a June 6, 2007 commentary in the Washington Times, using the same talking points as an anonymous blogger, likewise referring to Dr. Nissen as a 'self-appointed and media-anointed Patron Saint of Drug Safety' and 'Saint Steven the Pure'." Makes you wonder who coordinated all of these talking points, doesn't it?

And then there's Paxil, GSK's antidepressant. The FDA reviewed two studies which found that women who took Paxil in the first three months of pregnancy were 1-1/2 to two times more likely to give birth to a child with a heart defect than women who took other antidepressants or pregnant women overall. In addition, GlaxoSmithKline has now lost several lawsuits because it knowingly concealed years of negative information about the serious adverse reactions to Paxil. Not to mention the fact that as a result of GSK's fraudulent marketing of Paxil as non-addictive, they lost a major settlement in a class action suit filed on behalf of patients who got hooked on the drug, and then found they were unable to stop taking it.

Even now, GlaxoSmithKline faces a number of ongoing lawsuits regarding Paxil. For more information, or to participate in one of those lawsuits, check out: http://www.lawyersandsettlements.com/case/paxil-heart-defects-newborn.html.

But enough about GSK's commitment to your health. We could go on and on here. Suffice it to say: GSK's claim to be concerned for the reliability of studies concerning weight loss appears, at the very least, to be disingenuous.

The danger in the GSK petition

So why am I so concerned about the GSK petition?

First of all, it's an astounding expansion of the scope of the FDA labeling guidelines I mentioned earlier. As I mentioned in my blog on that issue, the key point in the guidelines is that "any herb or supplement that actually has any beneficial effect should be regulated by the FDA as if it were a drug if it actually helps with any medical condition" unless it is "generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling." At the time I wrote the blog, I expressed concern that based on the guidelines as written, if you were to claim on a label that drinking bottled water helped relieve a medical condition such as severe dehydration ( not just a medical condition, but a medical emergency), the new guidelines would mandate that water now be regulated as a drug. At the time, many in the alternative health community snickered at these concerns. Some people even left comments on the blog to that effect. But let me ask you now: What is GSK's petition to the FDA but an absolute expansion into the exact absurdity that I warned about? If you can claim that being overweight (an almost entirely self-inflicted state) is a medical condition for which all claims must be regulated because being overweight can "lead" to medical conditions, then there is no health related issue that cannot likewise be claimed to be a medical condition? What health issue is exempt?

What about vitamin C? A shortage of vitamin C in the diet leads to scurvy, a medical condition. By the applied logic, vitamin C should then be regulated as dealing with a medical condition and subject to the same rules. And what about dehydration? If no one can tell you that vitamin C provides health benefits, why would you buy it? Dehydration leads to medical conditions too, so water should also be regulated, yes? If no one can tell you that drinking water is healthier than drinking soda, why would you drink it?

You get the idea!

And if you think no one would ever bend and distort the FDA guidelines to do something that silly, think again. GSK just did! And the FDA is seriously considering their petition.

By the way, for those of you living outside the US, don't be smug. As I mentioned in the last issue of the newsletter, regulator's in the US and the rest of the world (particularly Europe) are moving ever closer in their regulatory zeal. And considering that the US is already more liberal than virtually all of the EU and Canada, you can be sure that any tightening in the US will be more than mirrored in your neck of the woods.

And so for the second time in less than two months, I find myself inspired to finish a newsletter with a quote from the movie, The Lord of the Rings. For all those of you who think that GSK's petition does not affect you, I once again give you Aragorn.

Aragorn (to Frodo): Are you frightened?

Frodo: Yes.

Aragorn: Not nearly frightened enough. I know what hunts you.

And in conclusion, I encourage you to check out the National Health Federation's call to action: http://www.thenhf.com/press_releases/pr_27_may_2008.html.

Fwd: Re: [Abes_Kids] New Book by a Kid

certainly hope so, but there are some concerning events happening that I have been paying attention to. The earth's magnetic field is weakening. Some places are large as Califonia are without a significant field, the Yellowstone Caldera has risen 100 feet and certain parts are closed as the ground temp is over 200 degrees. Last time it blew it covered most of the northern hemisphere in ash for a while. The interesting thing is that if the sun does eclipse the galactic center then, and we have a significant gravitational lens effect, this could be the tipping point even if it is small.  Right now we are suppose to be in a low cycle of sunspots and they are giving off more radiation than has been seen in a while. The next spike is in 2012......with no magnetic field = no protection......oh boy.....I for one hope there is no big event coming....... 

so I have a fondness for odd theories......LOL it's entertaining....

Aaron
aaron smith <ayn_seeker@yahoo.com>

Fwd: Toxins in Tap Water

Toxins in Tap Water

Water is good for you and we should drink it on a regular basis. Beyond those basic truths, there's little consensus on what's best when it comes to drinking water. While many people claim that the tap water supply in the US is the safest in the world, others are not so sanguine. Most recently, the news media widely reported that trace amounts of a whole pharmacopeia of medications, antibiotics to antidepressants to oral contraceptives, were detected in the water supply of major cities. Other stories have revealed that some bottling factories get their water from municipal sources, and further that the bottles themselves leach chemicals into the water. And then there's the environmental impact of all those plastic bottles tossed in the trash. So what's a thirsty person to do?

The facts, like some watering holes, are muddy at best. As it happens, bottled water and tap water are regulated by entirely different federal agencies. Tap water is always regulated by the EPA, but bottled water is regulated by the FDA -- sometimes. More on that in a minute.

FROM THE TAP

It's no surprise. You can't really assume the water that comes from your kitchen faucet is 100% safe. The EPA sets standards for approximately 90 contaminants in drinking water, including protozoan pathogens Cryptosporidium and Giardia (both of which can produce gastrointestinal illness like diarrhea and vomiting) plus other contaminants like lead, asbestos and arsenic -- but the testing and reporting is done by the water systems themselves, on the honor system. Plus, I was told by Cynthia Sass, MPH, MA, a registered dietitian and certified specialist in sports dietetics, there are many contaminants "not even on the radar of regulation." Additionally, according to a report by the environmental action group National Resources Defense Council, out of 19 cities tested, about one-fourth rated poor for water quality and compliance. A 2005 report by another consumer advocacy group, the Environmental Working Group, found that tap water in 42 states contained many contaminants that were dangerous, if not technically illegal. According to the report, of the 141 contaminants identified, 52 are linked to cancer, 41 to reproductive toxicity, 36 to developmental toxicity and 16 to immune system damage.

To confuse matters even more, the EPA has two levels of standards. The National Primary Drinking Water Regulations are mandatory and set quality standards for the contaminants mentioned above. The National Secondary Drinking Water Regulations set limits for an additional 15 contaminants that may affect taste, aesthetics (color or odor) or have cosmetic effects (like on the color of your teeth) but are not believed to pose a health risk. These secondary standards are not enforced by the EPA, they are simply stated as guidelines. Water suppliers are free to comply or not -- about 50% do.

Most health professionals think tap water is safe enough for most people, but agree that those with compromised immune systems should be careful. "If you're undergoing chemotherapy or if you're pregnant, you might have different concerns," Sass told me. The EPA suggests that people with compromised immune systems seek advice from their health care providers, but offers some guidance on its Web site: http://www.epa.gov/safewater/crypto.html.

The EPA's mandatory standard applies to water from municipal water supplies. Private wells that supply fewer than 25 people are not under government jurisdiction, so well owners should test annually since the EPA doesn't check individual residences. Local health departments can help provide guidance about well water quality (www.epa.gov/safewater/privatewells/index2.html).

IS BOTTLE BEST?

To avoid the whole issue, many people drink bottled water, believing that it's safer simply because it's bottled. Bottled water has become an enormous market, with more than 150 million Americans drinking it sometimes and 100 million doing so regularly. And indeed there are certain kinds of bottled water -- artesian well water and purified water -- that are as contaminant-free as any product is likely to be.

It's important to know that the FDA standards apply only to bottled water that is distributed nationally -- not regionally. However, an estimated 60% to 70% of the bottled water we buy in the US is regional, and thus exempt from FDA control. It's theoretically regulated at the state level, but only 40 of the 50 states actually do so and even those have limited or no resources for actual enforcement. To learn more about your state requirements, check with your state's water commission (known by other names, too, like Bureau of Water Quality Assurance or Water Resources Control Board, to name a few).

The situation is even more dismal for carbonated water and seltzer, which the FDA treats entirely differently from bottled waters. The FDA has some vague sanitation rules about these products with no specific limits on contaminants, and less than 50% of states require water in these categories to meet regular interstate bottled water standards.

WHICH WATER IS BEST?

The bottom line is that finding truly pure and safe water may take some detective work. It's relatively easy to check the quality of your tap water, as the EPA recently began requiring water suppliers to publish consumer confidence reports, which are water quality reports detailing where your water comes from and what's in it. These can be accessed by state on the EPA Web site at http://www.epa.gov/safewater/dwinfo.

You can also call the EPA's Safe Drinking Water Hotline (800-426-4791). Sass also suggested checking with consumer advocacy organizations like the aforementioned Environmental Working Group (www.ewg.org) and the Natural Resources Defense Council (www.nrdc.org). If you're going to drink bottled water, stick with the national brands since they're required to meet FDA purity standards.

ANOTHER SOLUTION

For my home, I purchased a reverse osmosis filter, which is an effective purifier. When I'm on the go, I bring along a stainless steel carrier bottle, which I keep filled with filtered water from my tap. Another option is to purchase a water filtration pitcher, such as Brita or Pur, and keep it filled with "clean" drinking water in your fridge. These are ways to feel more comfortable that the water you and your family drink is safe... and to minimize the environmental impact as well.

Source(s):

Cynthia Sass, MPH, MA, a registered dietitian and certified specialist in sports dietetics, based in New York City.

Fwd: ALERT: Monsanto Genetically Engineered Sugar to Hit U.S. in 2008

http://www.vanishingbees.com/
VIDEOS OF THE WEEK:
VANISHING OF THE BEES

We've highlighted this movie in Bytes before, but we strongly feel
this is truly a 'canary in the mine' issue.

This movie, which is nearing completion, analyzes why millions of
bees are dying around the world and how dramatically it could impact
the world's natural environment and food supply.

The producers are in need of donations to complete the film and are
currently eligible to receive matching funds from a foundation that
will double donations made by our readers.

View this breath-taking movie trailer here: http://www.vanishingbees.com


==========================================


ALERT: Genetically Engineered Sugar to Hit U.S. in 2008

Background Information:


American Crystal, a large Wyoming-based sugar company and several
other leading U.S. sugar providers have announced they will be
sourcing their sugar from genetically engineered (GE) sugar beets
beginning this year and arriving in stores in 2008.

Like GE corn and GE soy, products containing GE sugar will not be
labeled as such.

Since half of the granulated sugar in the U.S. comes from sugar
beets, a move towards biotech beets marks a dramatic alteration of the U.S. food supply.

These sugars, along with GE corn and soy, are found in many
conventional food products, so consumers will be exposed to
genetically engineered ingredients in just about every non-organic
multiple-ingredient product they purchase.

The GE sugar beet is designed to withstand strong doses of Monsanto's
controversial broad spectrum Roundup herbicide.

Studies indicate farmers planting "Roundup Ready" corn and soy spray
large amounts of the herbicide, contaminating both soil and water.

Farmers planting GE sugar beets are told they may be able to apply
the herbicide up to five times per year.

Sugar beets are grown on 1.4 million acres by 12,000 farmers in the
U.S. from Oregon to Minnesota.

Meanwhile candy companies like Hershey's are urging farmers not to
plant GE sugar beets, noting that consumer surveys suggest resistance
to the product. In addition the European Union has not approved GE
sugar beets for human consumption.

Ingredients from GE crops are not labeled in the U.S., once food
producers start using GE beet sugar in their candies, cereals,
breads, baby foods and other products, there will be no way for us to
know if we are eating GE sugar unless we buy organic foods, since GE
ingredients are banned in organic products.

http://www.organicconsumers.org/articles/article_7031.cfm



==========================================



MONSANTO, CARGILL, &ADM RAKE IN BILLIONS ON WORLD FOOD CRISIS


of crop seeds and germplasm, wheat, rice, soy, corn, and other grains.

While a billion people go hungry, and food riots threaten global
stability, these Biotech and Food Giants are raking in record
profits, along with Wall Street speculators, who have shifted their
greed from sub-prime mortgages to increasingly scarce natural
resources and food.

Learn more: http://www.organicconsumers.org/articles/
article_12088.cfm http://www.organicconsumers.org/articles/
article_12039.cfm



=================================================

CONSUMER TIP &ALERT:
HAZARDOUS & UNLABELED NANOTECH PESTICIDES IN CONSUMER PRODUCTS


An important lawsuit was filed last week against the Environmental
Protection Agency (EPA) by the International Center for Technology
Assessment calling for 200 consumer products to be removed from the
market, because they contain dangerous nanoparticle pesticides.

The EPA is illegally allowing a wide variety of consumer products to
be infused with nanoparticle-sized silver, supposedly for its
enhanced 'germ killing' abilities.

Nano-silver is now laced into products including children's toys,
personal care products, household appliances, cleaners, clothing,
cutlery, and coated electronics.

According to George Kimbrell, staff attorney for ICTA, 'Nano-silver
is leaching into the environment, where it will have toxic effects on
fish, other aquatic species and beneficial microorganisms.'

Nanotubes, one of the wonder materials of the new age of
nanotechnology, may carry a health risk similar to that of asbestos,
a wonder material of an earlier age that turned into a scourge after
decades of use when its fibers were found to cause lung disease,
researchers said Tuesday.

This time, the warning comes long before anyone has fallen ill, and
experts say the findings call for caution, not alarm, in handling
nanotubes, which are tiny, superstrong carbon fibers.

Although nanotubes are already found in some products, like tennis
rackets, researchers say the fibers appear to pose little risk to
consumers.

Nanotubes, discovered in 1991, are essentially rolled-up sheets of
carbon that can be used to produce materials that are far lighter and
stronger than steel, for example. But scientists have also long
wondered whether the needle-shaped nanotubes might cause the same
types of disease as needle-shaped asbestos fibers.

An article published Tuesday on the Web site of the journal Nature
Nanotechnology suggests that the answer may be yes.

A team of researchers reported that injecting nanotubes into the
abdomens of mice induced lesions similar to those that appear on the
outer lining of the lungs after the inhalation of asbestos.

In the case of asbestos, the lesions eventually become mesothelioma,
a deadly cancer.

The researchers, though, portrayed their results as good news by
providing people who work with nanotubes with knowledge of how to
minimize the dangers. "In a sense, we're forewarned and forearmed now
with respect to nanotubes," said Anthony Seaton, a professor of
environmental and occupational medicine at the University of Aberdeen
in Scotland.

Learn more about nanotechnology, take action, and see a comprehensive
list of everyday products containing nanotech here:
http://www.organicconsumers.org/nanotech.cfm

BBC NEWS | Politics | Hybrid embryos 'should be banned'

BBC NEWS | Politics | Hybrid embryos 'should be banned': "Hybrid embryos 'should be banned'
A human embryo
Critics say tinkering with human embryos is 'immoral'

Allowing scientists to carry out stem cell research using hybrid human-animal embryos 'is a step too far and should be banned', the Commons has been told.

Senior Tory MP Edward Leigh said there was 'no evidence yet to substantiate' the claims this could lead to treatment for Parkinson's and Alzheimer's."

Popular Drugs that Steal Nutrients

Popular Drugs that Steal Nutrients
Many Medications Deplete the Body of Important Vitamins and Minerals. Here’s How to Protect Your Health...
Frederic Vagnini, MD
Weill Cornell Medical College

reprinted from Bottom Line/Health, March 1, 2007
URL: http://www.bottomlinesecrets.com/blpnet/article.html?article_id=40837

Depletion of nutrients is among the most common -- and overlooked -- side effects of both over-the-counter (OTC) and prescription drugs.

Here's what happens: Medications can cause improper absorption of vitamins and minerals -- or they can accelerate the elimination of nutrients from the body. The consequences may range from bothersome symptoms, such as fatigue or stomach upset, to serious heart, muscle or nerve damage.

Most doctors are aware of some minerals that are depleted through the use of diuretics (water-excreting drugs). However, few doctors are aware of the dangers of nutrient depletion caused by many other types of medication, because the problem is not widely reported.

Popular drugs that deplete the body of nutrients...

ANTIBIOTICS

The most commonly prescribed antibiotics include azithromycin (Zithromax), amoxicillin (Amoxil), ampicillin (Omnipen), ciprofloxacin (Cipro), ofloxacin (Floxin) and erythromycin (Eryc).

Nutrients depleted...

B vitamins. The B vitamins are essential for normal metabolism as well as immune and nervous system functioning.

Vitamin K. This vitamin is critical for blood clotting and bone strength.

"Friendly" intestinal bacteria known as Bifidobacterium bifidum and Lactobacillus acidophilus. Antibiotics kill not only harmful bacteria but also "good" bacteria that promote gastrointestinal health and help balance immune response.

If you are prescribed an antibiotic: Ask your doctor about also taking a B-complex vitamin -- 50 mg... vitamin K supplement -- 60 micrograms (mcg) to 80 mcg... and probiotic supplements providing 15 billion live B. bifidum and 15 billion live L. acidophilus organisms daily.*

*If you're taking any medications, consult your doctor before changing your diet or beginning a supplement. In rare cases, increasing a nutrient may interfere with a drug's potency or worsen your condition.

In addition, eat more vitamin B-rich foods, such as beef liver, chicken, pork, fortified breads and cereals, whole-grain pastas, legumes, nuts and dark, leafy greens.

To increase your intake of vitamin K, eat kale... collard, turnip or mustard greens... spinach... broccoli... and Swiss chard.

Caution: Do not take vitamin K supplements or eat excessive amounts of vitamin K-rich foods if you take warfarin (Coumadin) or another blood-thinning drug.

For additional B. bifidum, eat more asparagus, garlic and/or onions, which stimulate growth of this friendly bacteria. For L. acidophilus, yogurt containing live cultures is your best food source.

High-Cholesterol Drugs

The most widely prescribed cholesterol-lowering "statins" include atorvastatin (Lipitor), simvastatin (Zocor), fluvastatin (Lescol), lovastatin (Mevacor) and pravastatin (Pravachol).

Nutrient depleted...

Coenzyme Q10 (CoQ10). All cells require CoQ10 for the proper function of mitochondria (tiny energy-producing structures within the cells). The more energy a cell must produce, the more it depends on CoQ10. That's why cells of the heart, in particular -- because it is constantly beating -- require an abundance of CoQ10.

Unfortunately, statin drugs, which effectively block the production of harmful cholesterol, also prevent CoQ10 production.

Some doctors worry that long-term use of statins may worsen heart failure. Studies have found that patients with chronic heart failure have lower CoQ10 levels, and that CoQ10 supplements may improve their heart condition. Signs of CoQ10 deficiency include fatigue and muscle weakness.

If you are prescribed a statin: Ask your doctor about taking 30 mg to 100 mg of a CoQ10 supplement daily. This nutrient also is available in some foods, including beef, chicken, salmon, oranges and broccoli.

Painkillers

Millions of Americans take a nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen (Motrin, Advil), naproxen (Aleve), celecoxib (Celebrex) and nabumetone (Relafen), to help relieve arthritis and other inflammatory pain.

Nutrient depleted....

Folic acid. Your body needs this water-soluble B vitamin to produce new cells and DNA and to synthesize and utilize proteins.

Several large epidemiological studies have linked low folic acid levels to increased risk for colon, breast and pancreatic cancers.

Heart health is also affected by folic acid. As folic acid levels decline, levels of the amino acid homocysteine rise. Studies suggest that elevated homocysteine can raise the risks for blood clots, heart attack and stroke.

Low folic acid levels may cause loss of appetite, irritability, weakness, shortness of breath, diarrhea, anemia, headaches, heart palpitations and a sore tongue.

If you take an NSAID regularly (daily for at least one to two weeks): Talk to your physician about also taking 400 mcg to 800 mcg of folic acid daily.

You also can get more folic acid by consuming fortified breakfast cereals, orange juice, spinach and other leafy greens, peas and beans.

BETA-BLOCKERS

Beta-blockers, such as propranolol (Inderal), atenolol (Tenormin), betaxolol (Betoptic S), carteolol (Cartrol) and labetalol (Normodyne), are commonly prescribed for high blood pressure or glaucoma.

Nutrients depleted...

CoQ10. Not only does CoQ10 appear to improve cardiac function in patients with chronic heart failure, studies suggest that it also may prevent second heart attacks and possibly protect against Parkinson's disease.

Melatonin. The hormone melatonin is essential for healthy sleep-wake cycles, and there's some early evidence that it may slow aging.

If you take a beta-blocker: Ask your physician about taking 30 mg to 100 mg of CoQ10 daily... and 1 mg to 3 mg of melatonin nightly, just before bed, if you have trouble sleeping.

ACE INHIBITORS

Angiotensin-converting enzyme (ACE) inhibitors, such as enalapril (Vasotec), benazepril (Lotensin) and ramipril (Altace), as well as angiotensin II receptor blockers (ARBs), including candesartan (Atacand) and irbesartan (Avapro), are prescribed for high blood pressure and heart failure, and to help prevent heart attacks in high-risk patients.

Nutrient depleted...

Zinc. Zinc boosts immunity, and some studies have shown that it reduces the duration of cold symptoms.

Zinc also is necessary for wound healing, strong bones and male potency, and it may help slow the progression of age-related macular degeneration (AMD).

In a recent six-year National Eye Institute study involving 3,600 people with AMD, zinc and antioxidant supplements reduced the risk of developing advanced AMD by 25%.

If you take an ACE inhibitor or ARB: Ask your doctor about taking 50 mg to 100 mg of zinc daily and eating more zinc-rich foods, such as oysters, beef, dark-meat chicken, pork tenderloin, yogurt, milk, peas, beans and nuts. If you continue to take zinc indefinitely, do not exceed 50 mg daily.

Important: Many medications combine an ACE inhibitor or ARB with a diuretic -- for example, enalapril and hydrochlorothiazide (Vaseretic) is an ACE inhibitor plus a diuretic... candesartan and hydrochlorothiazide (Atacand HCT) is an ARB plus a diuretic.

If you're taking a combination drug, you'll need to compensate not only for zinc, but also for the electrolytes and nutrients excreted by the diuretic, including potassium, magnesium, thiamine (B-1) and calcium. Ask your doctor for advice.

Diabetes Drugs

People with type 2 diabetes are often prescribed tolazamide (Tolinase), acetohexamide (Dymelor), glimepiride (Amaryl) or glipizide (Glucotrol) -- all sulfonylurea drugs. These medications stimulate the pancreas to produce more insulin, which lowers blood sugar.

Nutrient depleted...

CoQ10. Diabetes more than doubles your chances of dying from heart disease or stroke -- and low CoQ10 levels exacerbate those risks.

If you're taking a sulfonylurea drug: Ask your doctor about supplementing with 30 mg to 100 mg of CoQ10 daily.

Reflux Drugs

Proton pump inhibitors, such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec) and rabeprazole (AcipHex), are prescribed for chronic heartburn -- also known as gastroesophageal reflux disease (GERD) -- and ulcers.

Nutrient depleted...

Vitamin B-12. Vitamin B-12 is essential for producing red blood cells and maintaining a healthy nervous system. Deficits may cause fatigue, dizziness, shortness of breath, diarrhea, tingling in the hands or feet, unsteady gait, nervousness, cognitive changes and even dementia.

Vitamin B-12 is found in red meat, fish, eggs and dairy foods, but our bodies require stomach acid to release the vitamin from these foods. Proton pump inhibitors reduce the production of stomach acid, inhibiting the release and absorption of vitamin B-12.

Iron. Low iron reduces the amount of oxygen your red blood cells can transport to body tissues, leaving you feeling weak and fatigued. A serious iron deficiency results in anemia.

If you take a proton pump inhibitor: Ask your doctor about taking 500 mcg to 1,000 mcg of vitamin B-12 daily and for advice on the best way to increase your iron intake.

Caution: Never take an iron supplement without consulting your physician -- excess iron can accumulate in your major organs and cause severe damage. Most people, however, can safely eat more iron-rich foods, including liver, beef, dark-meat chicken or turkey, legumes and fortified cereals.

Bottom Line/Health interviewed Frederic Vagnini, MD, medical director of the Heart, Diabetes and Weight-Loss Centers of New York and an assistant clinical professor of surgery at Weill Cornell Medical College, both in New York City. Dr. Vagnini is coauthor of The Side Effects Bible: The Dietary Solution to Unwanted Side Effects of Common Medications (Broadway).

AMERICAN THEOCRACY, BY KEVIN PHILLIPS

AMERICAN THEOCRACY, BY KEVIN PHILLIPS: "Home Commentary Table of Contents Preface About the Author Reviews Other Books Buy the Book
'American Theocracy may be the most alarming analysis of where we are and where we may be going to have appeared in many years. It is not without polemic, but unlike many of the more glib and strident political commentaries of recent years, it is extensively researched and frighteningly persuasive...By describing a series of major transformations, by demonstrating the relationships among them, and by discussing them with passionate restraint, Phillips has created a harrowing picture of danger that no American reader will welcome, but that none should ignore.'

The New York Times Book Review, March 19, 2006

'American Theocracy serves as an invaluable resource, given its marshaling of facts and figures, as well as the breadth and depth of its historical analyses... Overall, Phillips’ book is a thoughtful and somber jeremiad, written throughout with a graceful wryness...a capstone to his life’s work.'

Chicago Sun-Times, March 12, 2006

"Phillips makes a very interesting argument that the old North-South split in this country is far deeper and more ingrained than most people realize, and that one way of looking at American politics today is to say that the South managed the aftermath of its defeat in 1865 that it is now the dominant section of the country."

Baltimore Sun, March 12, 2006