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Friday, June 15, 2007

Here you have some science to counter the HYPE

Most people know little about the two key players in the artificial sweetener market, aspartame and sucralose.

What they do know is more likely than not limited to the marketing and advertising HYPE blasted over the airwaves, online or in print. What they buy into is really a long known health dive, and the risk of very serious problems over time. In some, the problems can and do appear almost immediately.

Aspartame and sucralose (Nutrasweet and Splenda)have in common the fact that both were developed as insecticides. Very few know this, including your local health care provider.

Aspartame is a chemical soup of ingredients that turn into methyl (wood) alcohol when exposed to heat and during digestion.

Sucralose is, according to the Splenda International Patent A23L001-236 and PEP Review #90-1-4 (July 1991), synthesized by this five-step process:
1. sucrose is tritylated with trityl chloride in the presence of dimethylformamide and 4-methylmorpholine and the tritylated sucrose is then acetylated with acetic anhydride,
2. the resulting TRISPA (6,1',6'-tri-O-trityl-penta-O-acetylsucrose) is chlorinated with hydrogen chloride in the presence of toluene,
3. the resulting 4-PAS (sucrose 2,3,4,3',4'-pentaacetate) is heated in the presence of methyl isobutyl ketone and acetic acid,
4. the resulting 6-PAS (sucrose 2,3,6,3',4'-pentaacetate) is chlorinated with thionyl chloride in the presence of toluene and benzyltriethylammonium chloride, and
5. the resulting TOSPA (sucralose pentaacetate) is treated with methanol (wood alcohol, a poison) in the presence of sodium methoxide to produce sucralose. (1)

Even if you don't know what the chemicals are, it should scare any sensible person.

"Splenda (sucralose) is created in the lab, using a complex process involving dozens of chemicals you and I can barely pronounce - let alone consume. Basically, the chemists force chlorine into an unnatural chemical bond with a sugar molecule, resulting in a sweeter product, but at a price: a huge amount of artificial chemicals must be added to keep sucralose from digesting in our bodies. These toxic substances prevent (hopefully) the dangerous chlorine molecules from detaching from the sugar molecule inside the digestive system, which would be a carcinogenic hazard."

So here you have it, and hopefully you too will question these products and stop using them. Find out more at wwww.dorway.com.

Never too late to read the labels on what you buy.

Safe alternatives are agave, stevia and Just Like Sugar.

Sunday, June 10, 2007

Using the Right Food Achieves the Same Effect, Naturally and Safely

Of course when money is the driving factor little or no research into nutrition and its relationship to health problems is seen.

Eating Sesame Seed, Halvah, and using Sesame Seed Oil in your diet - all promote platelets.

Food indeed is YOUR BEST MEDICINE

--------------------------------------------------
Glaxo drug hikes platelets, cuts bleeding in study
Sat Jun 9, 8:51 AM ET

GlaxoSmithKline Plc's experimental platelet-boosting drug eltrombopag has produced further positive results in patients with idiopathic thrombocytopenia purpura (ITP), researchers said on Saturday.

Eltrombopag, which Glaxo plans to sell as Revolade in Europe and Promacta in the United States, is one of several novel drugs in the group's pipeline which it believes have blockbuster potential.

Results from a pivotal Phase III study presented at the European Hematology Association congress in Vienna showed 50 to 75 milligrams once daily resulted in a statistically significant increase in platelet counts and also reduced bleeding in people with chronic ITP.

The placebo-controlled trial involved 114 adults and patients studied had previously received and failed current standard ITP treatments.

ITP is an autoimmune disease which results in low blood platelet counts. Because platelets contribute to blood clotting, patients with low counts bleed more easily than others, heal more slowly and bruise more often.

Eltrombopag, which is given as a pill, was discovered as a result of a research collaboration between Glaxo and Ligand Pharmaceuticals Inc..

Tuesday, May 29, 2007

Best look out for egos

Because our focus is health, and better yet, NATURAL HEALTH, that means we include environment in our definition.

Now environment to some may be a bad word, except when they think they can muscle in on on everyone and come out on top. SO that to me implies bullyism and ultimately greed. You know, that old saw about "he who has the most toys wins".

Well there seems to be a greedy son-of-a ...fertilizer sprayer guy out of Ohio that thinks he and his new mega corporation will take over the environment hands down.

That environment to him is your lawn and garden. And in his fervor he plans to squash all the recycled soda bottles and worm waste he can, just to keep them out of his way.

That way is not the yellow brick road but the plan to the takeover and control the more ecological product line of a great idea start-up company.

You may have guessed it by now, the guy who thinks he is such a big shot because he's logged over 500,000 miles in the corporate jet in a year is the Scotts/Miracle Gro CEO.

He's on a 'verre de terre' hunt, big time. No nets, just intimidating tactics to scare some the new guys on the block. Yes, it's that old corporate tactic of ego puffing and fear mongering. Really tells you a lot about Scotts corporate social responsibility doesn't it.

Did he forget that Santa, when working for Macy's, told people to shop at Gimbels.

Or, you might say, I bet the guy never read 'Small is Beautiful' or took a course in whole system design.

That's probably true.

So what can we learn from all this?

Well the point is that your garden, and the gardens that feed a lot of us from small family farms, can improve your environment if you improve on them. Simply improve the soil and what feeds what you grow. Yes, we are all a part of it and the circle does go round and round.

Tune in to TerraCycle and learn about the great idea that flourished from the "garbage, garbage, garbage" of some Princeton dining hall and the tons of empty milk jugs and soda bottles thrown away daily in this country.

Bless Thomas Edison and ingenuity!

If you know anything at all about worms you know that they can turn your household garbage into great fertilizer and use it to up the yield of that victory garden you've planted for this year's season.

But now comes the guy on the jet who says "Whoa, you can't do that". Just like his Monsanto buddies that urge you to use RoundUp. All that does is increase your risk of cancer and give you bigger weeds to kill with more and more RoundUp.

I'm packing some big guns here and you don't cross my corner.

Snidely WhipScott rears his ugly head and sends out the attorneys (those legal larcenists that go for the $$$ you know) to start that paper trail.

For the rest of the story its your turn to check it out because I've never seen a package of anything look like MiracleGro or Scotts, Even all that good stuff from my usual supplier Garden's Alive(purchase via our shpping village to help support our work). Now that I've seen TerraCycle, there sure is someone out of Ohio lacking in visual acuity.

Gee, Arlo where are you? We need a new song.

In the interim, return all your Scotts and go for the GLOW(worm, that is).

Monday, April 23, 2007

Oprah's Down the Rabbit Hole

I have an on-going theme in 2007 for my newsletter, herbalYODA Says! It has to do with a single issue I have named 'falling for fabrication'. I titled it this way because as I peruse the plethora of news reports of interest to me - those about health and environment, nutrition, electrosmog and related topics - I see an overall pattern of what is pure propaganda.

Nowadays some folks take exception with Noam Chomsky but at the very least he makes you think. He also addresses issues of 'falling for fabrication' in his well known book, 'Manufacturing Consent'.

This is an important concept and it is aimed at directing your thinking and decision making to more or less a 'mob mentality'.

Now this brings us to mercury. You know that slippery, shiny heavy metal that is very toxic to humans, plants and animals, and the environment.

Mercury (chemical symbol Hg(C.A.S. 7439-97-6)) is
an element that occurs naturally in the environment. It is a silver-white, heavy metal that is liquid at room temperature; as a solid, it is tin-white and can be cut with a knife. It can also be found in compounds with other chemicals such as chlorine in the same way that sodium is found in table salt.

Mercury is used in pure form in thermometers, barometers, and other consumer products. Batteries containing mercury are used in devices ranging from guided missiles and space craft to hearing aids, cameras, toys, portable radios, calculators, measuring devices, smoke alarms, self-winding watches, and radio microphones. Electric or mercury lamps are used for outdoor lighting, including floodlights and street lights, motion picture projection, health treatment, and photography. Mercury is also used as a catalyst in the production of vinyl chloride monomer, urethane foam, and anthraquinone. It is used in diuretics, antiseptics, and skin preparations.

Prior to August 20, 1990, mercury was added to paints as an anti-mildew agent, antibacterial agent, and fungicide; about one-third of all interior latex paint contained varying levels of mercury. (Oil-based paint does not contain mercury.) Mercury is also used in pigments, refining, lubrication oils, and dental amalgams.

Mercury in one form, "organic mercury," can become highly concentrated in the flesh of certain fish. For this reason relatively low levels of mercury contamination in the ocean and lakes can lead to toxic contamination of these fish. Organic compounds of mercury are phenylmercury acetate (C8H8HgO2) and methylmercuric chloride (CH3HgCl). Other compounds of mercury, called "inorganic mercury," are mercury, mercuric II acetate or mercury salt (HgC4H6O4c), mercuric II chloride (HgCl2c), and mercurous I chloride (Hg2Cl2c).

Chemical properties:

Mercury that is released into the environment will remain there indefinitely. The form that mercury exists in (organic or inorganic) may change with time. Some or all of released organic mercury will slowly decompose to become inorganic mercury. Some portion of released inorganic mercury will be slowly transformed into organic mercury by bacteria in soil or water.

Mercury is not flammable and does not have an odor. Some mercury salts and organic compounds are soluble in water, depending on the chemical species.

Synonyms for mercury are colloidal mercury; kwik; liquid silver; quicksilver; metallic mercury; and hydrargyrum.

Identification:

* Chemical Name: Mercury
* Regulatory Name: Mercury
* Formula: Hg
* DOT Label: Corrosive
* CAS: 7439-97-6
* STCC: 4936336
* CHRIS: MCR
* UN Number: 2809

Health effects:

Mercury, in both inorganic and organic forms, is toxic to humans and can cause death. The organic forms of mercury such as methylmercuric chloride and phenylmercuric acetate have been found to be more toxic than inorganic forms such as mercuric chloride. More severe effects on developing nervous systems are generally observed following exposure to organic mercury.

Deaths have been reported following acute exposure to high unspecified concentrations of metallic mercury vapor caused by a loss of respiratory function as a result of severe pulmonary tissue damage. Oral ingestion of single doses of mercuric chloride has led to poisoning and death caused by shock, cardiovascular collapse, acute renal failure, and severe gastrointestinal damage. Most reported cases of poisoning from organic mercury compounds are a result of the ingestion of contaminated fish or grains.

Long-term exposure to either organic or inorganic mercury can irreversibly damage the brain, kidneys, or developing fetuses. The form of mercury and the way humans are exposed to it influence which of these health effects will be more severe.

For example, organic mercury that is eaten in contaminated fish or grain will tend to cause greater harm to the brain and developing fetuses than to the kidney; inhaled inorganic mercury vapor will tend to cause greater harm to the brain; and inorganic mercury that is eaten or drunk in contaminated food or water will tend to cause greater harm to the kidneys.

Effects to the developing fetus include brain damage. Effects in adults briefly exposed to mercury include shakiness, tremors, and memory loss.

Exposure Values:

* IDLH: 10 mg/m3 (NIOSH, 1997)
* TLV TWA: 0.025 mg/m3. Not classifiable as human carcinogen.
* (ACGIH, 1999)
* NIOSH REL: Hg Vapor: TWA 0.05 mg/m3 [skin], Other: C 0.1 mg/m3 [skin]
* OSHA PEL: C 0.1 mg/m3

Economics:

U.S. manufacturers of mercury are Centerchem, Inc, New York, NY; Rascher & Betzold, Inc, Chicago, IL; SST Corporation, Clifton, NJ; Eastman Kodak Laboratory and Specialty Chemicals Eastman Kodak Co, Rochester, NY; Spectrum Chemical MFG Corp, Gardena, CA; D F Goldsmith Chemical & Metal Corp, Evanston, IL; and Belmont Metals, Inc, Brooklyn, NY.

Mercury is produced mainly by mining. Five percent of the world mercury production is a by-product of gold mining, and most of the remaining mercury is produced from underground mines. Some salvage is done on scrap materials as well.

U.S. production of mercury in 1985 was 1,254,000 pounds; world production in 1986 was 13,376,000 pounds. In 1986, almost 1,520,000 pounds of mercury were imported to the United States.

Regulation:

The U.S. Food and Drug Administration (FDA) has issued permissible levels of mercury in bottled water. The Occupational Safety and Health Administration (OSHA) has issued permissible exposure limits for mercury.

The U.S. Environmental Protection Agency prohibited adding mercury to paint after August 20, 1990. However, paint manufactured before that ban can still be sold.

EPA offices overseeing regulations and guidelines for mercury are Air Quality Planning and Standards, Water and Standards, Emergency and Remedial Response, Solid Waste, and Toxic Substances.

Under the Emergency Planning and Community Right-to-Know Act of 1986, releases of more than one pound of mercury into the air, water, or land must be reported annually and entered into the National Toxic Release Inventory (TRI).

Under Section 313 of the Emergency Planning and Community Right to Know Act of 1986, releases of more than one pound of mercury into the air, water, and land must be reported annually and entered into the Toxic Release Inventory (TRI).

National Overview of 1998 Toxics Release Inventory

In 1998, 340 facilities released 291,341 pounds of mercury. Of those releases, 22,007 pounds were air emissions; 134 pounds were surface water discharges; 0 pounds were released to land; and 239,072 pounds were transferred off-site for disposal. Total emissions for 1998 represented an increase from 1997 emissions, which totaled 45,125 pounds; from 1996 emissions, which totaled 28,198 pounds;an increase from 1995 emissions, which totaled 28,591 pounds; and a decrease from 1988 (baseline) emissions, which totaled 296,299 pounds.

In 1998, 776,222 pounds of mercury waste were managed; 455,629 pounds were recycled on-site; 34,068 pounds were recycled off-site; 0 pounds were used for energy recovery on-site; 0 pounds were used for energy recovery off-site; 4,315 pounds were treated on-site; 1,165 pounds were treated off-site; and 281,045 pounds were released on-and off-site.

The 10 states in which the largest amounts of mercury were released in 1998 were: NV (224,400 pounds); SC (21,019 pounds); TN (3,279 pounds); KY (2,320 pounds); OH (1,653 pounds); GA (1,326 pounds); NC (1,283 pounds); WV (1,258 pounds); LA (1,226 pounds); and IN (1,110 pounds).

The 10 facilities releasing the largest amounts of mercury in 1998 were: Getchell Gold Corp., Golconda, NV (144,000 pounds); Jerritt Canyon Joint Venture, Elko, NV (80,400 pounds); Safety-Kleen (Pinewood), Pinewood, SC (21,019 pounds); Olin Corp., Charleston, TN (3,279 pounds); Ashta Chemicals Inc., Ashtabula, OH (1,653 pounds); Olin Corp., Augusta, GA (1,326 pounds); Holtrachem Mfg. Co. Llc, Riegelwood, NC (1,283 pounds); Ppg Inds. Inc., New Martinsville, WV (1,258 pounds); Pioneer Chlor Alkali Co. Inc., Saint Gabriel, LA (1,226 pounds); and Osram Sylvania Prods. Inc., Versailles, KY (1,203 pounds).

Notations:

The NIOSH recommended exposure limits (RELs) are time-weighted average (TWA) concentrations for up to a 10-hour workday during a 40-hour workweek. A short-term exposure limit (STEL) is designated by "ST" preceding the value; unless noted otherwise, the STEL is a 15-minute TWA exposure that should not be exceeded at any time during a workday. A ceiling REL is designated by "C" preceding the value. Any substance that NIOSH considers to be a potential occupational carcinogen is designated by the notation "Ca."

The OSHA permissible exposure limits (PEL) are found in Tables Z-1, Z-2, and Z-3 of the OSHA General Industry Air Contaminants Standard (29 CFR 1910.1000). Unless noted otherwise, PEL are TWA concentrations that must not be exceeded during any 8-hour workshift of a 40-hour workweek. A STEL is designated by "ST" preceding the value and is measured over a 15-minute period unless noted otherwise. OSHA ceiling concentrations (designated by "C" preceding the value) must not be exceeded during any part of the workday; if instantaneous monitoring is not feasible, the ceiling must be assessed as a 15-minute TWA exposure. In addition, there are a number of substances from Table Z-2 (e.g., beryllium, ethylene dibromide, etc.) that have PEL ceiling values that must not be exceeded except for specified excursions. For example, a "5-minute maximum peak in any 2 hours" means that a 5-minute exposure above the ceiling value, but never above the maximum peak, is allowed in any 2 hours during an 8-hour workday.

Information Sources:

* CAMEO®, U.S. Environmental Protection Agency, National Oceanic and Atmospheric Administration, www.epa.gov/ceppo.
* Chemical Manufacturers Association, 1300 Wilson Blvd., Arlington, VA 22209: (703) 741-5000 or Chemical Referral Library, (800) 262-8200.
* National Institute of Environmental Health Sciences, Clearinghouse on Environmental Health Effects, 100 Capitola Drive, #108, Durham, NC 27713; (800) 643-4794; fax (919) 361-9408.
* TOXNET, National Library of Medicine, National Institutes of Health; www.toxnet.nlm.nih.gov
* U.S. Environmental Protection Agency, 401 M St., SW, Washington, DC 20460; Right to Know Hotline (800) 535-0202.
* U.S. Department of Labor, Occupational Health and Safety Administration, Washington, DC, www.osha.gov
* OSHA PEL: Z-1 Table: www.osha-slc.gov/OshStd_data/1910_1000_TABLE_Z-1.html
* OSHA PEL: Z-2 Table: www.osha-slc.gov/OshStd_data/1910_1000_TABLE_Z-2.html


You know not to eat too much tuna, and you've probably turned in your mercury filled thermometer for one filled with alcohol of a digital type.

You probably know the devastating effects of mercury used as a preservative in vaccines, which since 1926 has been known by the AMA to cause mental impairment and brain damage.

And maybe you know that the "Mad Hatter" from 'Alice in Wonderland' was called that because of his hat - the felt hat manufactured with mercury.

So here we are in 2007 and all the folks whose words determine your choices, mostly without any investigation on your part, have gone down the Rabbit Hole after breathing too many mercury fumes.

If you are on the subscriber list to herbalYODA Says! you have received our Earth Day special issue on the CFL bulb.

Yes, its that compact fluorescent light bulb (CFL) hawked every where as a way to reduce global warming. Even Oprah is giving them away!

Now Oprah took on the Texas cattlemen some years ago in a big fight. I think it is fair to take on Oprah when she pushes something that just might now be good for you. If you read this blog you know I have challenged her on a few other issues. I probably will challenge her and others again, for the pure purpose of getting you to put your thinking hat on.

Yes, I was at the very first Earth Day and it seems really a long time ago. I don't see that much has has changed.

It must be a microcosmic effort because I do know individuals to whom the environment is very much worth protecting. As we always said on the Rez, "Love Your Earth Mother".

I guess we need to look at this in a different way now as the fabrication of events through advertising and marketing causes many of us to fall for the Madison Avenue hype, what is popular for the moment.

Here is another example, following on the war cry of recent flooding of the Internet with messages about writing to stop vegetable juice from becoming a 'drug'.

Look at almost every event, Yahoo and other web special sites, global warming web sites, news ads, rock concerts, ad infinitum. What are these all pushing this weekend? CFL.

So they want us to light the Earth Mother with something they tell us will save energy.

Maybe so, and I thought so too over a decade ago when I bought one these bulbs to go in a lamp I had on a timer so my house would not be dark when I arrived home fore the evening.

At the end of last year I had a nice e-chat with the fellow who runs the local recycling center.

Hey Andy, I wrote, what about the mercury in these light bulbs and what'll it do to the landfill?

Andy already knew about the mercury in the 'compact fluorescent bulb' so we went on to address the radio frequency generated by the bulbs and what this might do to your health in a house full of these swirling glass tubes. Yes, I did say radio frequency, or RF or EMF as more people might call it.

I don't get grants from Philips who is funding the bulb give away on college campuses this weekend. Maybe Philips might like to send some funds the way of Creating Health Institute to help sponsor our environmental work. Like this special edition of out newsletter. And maybe Sheryl Crow might send us a few dollars or so from increased album sales after giving away the free light bulbs at these concerts.

Then there is 18Solutions.org also out there telling us that since 1 January 2007 more than 30 million of these bulbs have been sold. Stopglobalwarming.org is hawking the bulbs too, as I am sure are many other power companies and organizations.

Now, about two months after I posted this information on my blog, I see World Net Daily is reporting on health hazards of CFL.

Hopefully this turns on your old bulb before jumping on the wagon...

More to follow on 'falling for fabrication'.

As always you will find more information about the topics covered in this and other issues of our newsletter on our web site at http://www.leaflady.org/ (http://www.leaflady.org/ ), and on our blog at http://naturalhealthnews.blogspot.com
(http://naturalhealthnews.blogspot.com/).

herbalYODA Says! is written by Gayle Eversole, DHom, PhD, MH, NP, ND.
Creating Health Institute, celebrating 50 years in natural healing, blending science with the natural healing arts. We bring it to you as a public service, and part of our long established Health Matters© educational publications.

CHI is a tax-exempt, non-profit 501(c)(3) organization. We ask that you consider helping us continue our work through your tax-deductible donation, through our shopping villages, products and services.

CHI Copyright © 2007. All Rights Reserved.


The CFL contains mercury! If it breaks inside your home it releases mercury. It harms the environment because it is toxic waste and ends up somewhere in a landfill.

It can make you sick in other ways because it is a radio frequency emitter. RF is something you do not see, but it can affect your health.

There are other options. In the early days of the environmental movement we turned off the light when we did not need it. Now you can buy halogen or full spectrum light bulbs or very long life bulbs, so you do have a choice.

Just leave the mercury alone.

Wednesday, April 18, 2007

What we warned about Gardasil is now filtering into the media

But behind the scenes, Gardasil has been dogged by uncertainty about how effective it really is. Merck won approval for the vaccine based on research that showed it protected against two strains of the human papillomavirus, known as HPV 16 and 18, that are thought to cause 70% of cervical-cancer cases. The Food and Drug Administration didn't ask its panel of experts advising on Gardasil to rule on whether the vaccine specifically prevented the cancer itself. In clinical trials, 361 of 8,817 women who received at least one shot of Gardasil went on to develop precancerous lesions on their cervixes within three years of vaccination, just 14% fewer than in a placebo control group.


This paragraph alone should raise the ire of women who have 'rallied' behind this vaccines because of propaganda. Mothers of daughters should be especially irate. A sweeping blitz campaign should immediately be directed to your Members of COngress and state legislatures where laws have benn passed to mandate this shot.

Vaccines promote disease and it has been shown true through scientific research, over and over again. FMI: vaclib.org


The Wall Street Journal, April 16, 2007
VIRAL MARKETING

Questions on Efficacy Cloud a Cancer Vaccine
By JOHN CARREYROU

When Merck & Co. introduced its new vaccine against cervical cancer last June, it gave it one of the biggest pushes any new medicine has received. The company lobbied dozens of states to make the vaccine mandatory for 11- and 12-year-old girls. It aired TV ads featuring young girls skipping rope while reciting the slogan, "I want to be one less" woman to battle the disease.

The campaign scored some big victories. The Centers for Disease Control and Prevention declared all women age 11 to 26 should get the vaccine, called Gardasil. Texas and Virginia passed mandatory-vaccination laws for girls entering the sixth grade. Even after Merck halted its lobbying in February amid criticism, an organization backed by the company continues to push for similar laws, and about 20 states are considering them. The vaccine costs $360 for a three-shot regimen. (See the full CDC recommendations.1)

RELATED DOCUMENTS
See the full CDC recommendations2 on the HPV vaccine.
See a recent presentation by Merck's Eliav Barr3 giving the latest data on Gardasil's efficacy.
Read the background document4 an FDA reviewer prepared for the advisory committee that assessed the vaccine on May 18, 2006, and see a full transcript of that meeting5.

But behind the scenes, Gardasil has been dogged by uncertainty about how effective it really is. Merck won approval for the vaccine based on research that showed it protected against two strains of the human papillomavirus, known as HPV 16 and 18, that are thought to cause 70% of cervical-cancer cases. The Food and Drug Administration didn't ask its panel of experts advising on Gardasil to rule on whether the vaccine specifically prevented the cancer itself. In clinical trials, 361 of 8,817 women who received at least one shot of Gardasil went on to develop precancerous lesions on their cervixes within three years of vaccination, just 14% fewer than in a placebo control group.

Scott Emerson, a professor of biostatistics at the University of Washington who sat on the FDA advisory committee, says he's not persuaded the vaccine is worth the billions of dollars likely to be spent on it in coming years. "I do believe that Gardasil protects against HPV 16 and 18, but the effect it will have on cervical-cancer rates in this country is another question entirely," says Dr. Emerson. "There is a leap of faith involved."

Merck says the 14% figure is misleading because more than a quarter of the women in the study were already infected with HPV before receiving the vaccine, blunting its effect. Gardasil isn't designed to treat those with pre-existing infection. The company prefers to point to a subset of 4,616 trial participants who were mostly free of HPV when they were vaccinated. Only 52 of these women went on to develop precancerous lesions on their cervixes over the next three years, 46% fewer than among the placebo group. Merck says this smaller group of women is the one most representative of the 11- and 12-year-old girls for whom Texas and Virginia have required vaccination. (See a recent presentation by Merck's Eliav Barr7 giving the latest data on Gardasil's efficacy.)

Safety is another issue. Merck tested the vaccine in only a few hundred 11- and 12-year-old girls. Some doctors consider that number too small to declare the vaccine safe for preteen girls, given the big changes their bodies undergo.

In its approval letter, the FDA ordered Merck to follow "a sufficient number of children 11-12 years of age" in a large postmarketing study to further establish the vaccine's safety. That study won't be completed until 2009. Norman Baylor, the director of the Office of Vaccines Research and Review at the FDA, says it's common for the agency to recommend postmarketing studies for vaccines, and the FDA considers Gardasil safe.

The company says it complied with the FDA's request that the clinical trials include more than 3,000 9- to 17-year-olds. It adds that it didn't test Gardasil more widely on girls because it wanted to focus on sexually active women to demonstrate the vaccine's efficacy. So far, Merck has distributed more than four million doses of the vaccine in the U.S., and the CDC says adverse events have been mostly minor and within the normal range.

Eliav Barr, the head of Merck's HPV vaccine program, says Gardasil is a "lifesaving" vaccine and its widespread adoption will result in "a substantial decline in the rate of cervical cancer." Dr. Barr says Merck provided "an extremely strong dossier" on Gardasil that both the FDA and the CDC have deemed satisfactory.

Merck has a lot riding on Gardasil. It faces patent expirations on other best sellers and legal costs related to Vioxx, the withdrawn painkiller linked to heart attacks and strokes. Some analysts believe Gardasil's annual sales could reach $2 billion or more by 2010.

Work on a cervical-cancer vaccine goes back nearly two decades, after scientists discovered that HPV infection can trigger lesions of the cervix that eventually turn into cancer. In the early-to-mid-1990s, Merck licensed patents held by the National Cancer Institute and CSL Ltd. of Australia, and began work on commercializing the vaccine.

From the start, Merck faced a challenge in winning acceptance of the vaccine as a universal necessity for American women. Though common in developing nations, cervical cancer is a relatively rare disease in the U.S., accounting for about 0.7% of cancer diagnoses and deaths each year. Women already have a highly effective method of prevention: visiting a gynecologist for regular Pap tests. The low-tech exam has contributed to an 80% reduction in cervical-cancer deaths in the U.S. over the past 50 years.

Human studies of the present version of the vaccine, which also targets two HPV strains that cause genital warts, began in 2000. The vaccine was administered to more than 20,000 women. It is delivered in three injections over six months. Merck submitted Gardasil to the FDA for approval in 2005.

Hints of Trouble [Gardasil Gold]
A meeting of the FDA advisory panel that reviewed Gardasil in May 2006 gave the first hint of Merck's troubles in persuading doctors of Gardasil's real-world efficacy. In its presentation, Merck stressed the vaccine's nearly 100% effectiveness in blocking infection by HPV 16 and 18 and in preventing precancerous lesions caused by those two strains. But a document prepared for the committee by an FDA reviewer noted the vaccine's limited overall efficacy against precancerous lesions in the broader group of nearly 9,000 trial participants. (Read the FDA reviewer's document.8)

Dr. Emerson, the University of Washington professor, expressed concern that Merck wasn't putting enough emphasis on the question of whether the vaccine prevented cervical cancer. "It's almost the treating the symptom but not the disease sort of idea," he said, according to a transcript of the meeting. (Read the transcript.9)

Merck pointed to the confounding factors behind the lower efficacy rates, including the problem of women who came into the trial already infected. In an interview, Merck's Dr. Barr says Gardasil's true efficacy will become more apparent with time, particularly in the group that includes women with a pre-existing infection.

While Merck often states that Gardasil prevents infection with viruses that account for 70% of cervical-cancer cases, Dr. Barr concedes that the vaccine is less than 70% effective against precancerous lesions. Merck says this is because the HPV strains not covered by Gardasil cause disproportionately more precancerous lesions that don't end up turning into cancer.

Efficacy against lesions is a significant issue because after a Pap test, doctors generally remove any lesions that reach a certain grade of seriousness, even though some might not turn into cancer. The surgery involves cutting out part of the cervix and can cost several hundred to several thousand dollars. Dr. Barr predicts Gardasil will eventually be shown to prevent nearly 60% of precancerous lesions that doctors would want to remove among women who were free of HPV infection when they were vaccinated.

Ultimately Gardasil received the panel's unanimous approval, and the FDA approved the vaccine in June 2006. The agency reasoned that waiting for more data would prevent some women who needed the vaccine from getting it.

With the FDA's approval, Merck faced a new challenge: persuading the public to take its vaccine. It got a quick boost from the CDC, which issued guidance in late June recommending that all girls receive the vaccine at age 11 or 12. The CDC said women age 13 to 26 should also get the vaccine. Gardasil was also endorsed by the American Academy of Pediatrics.

Merck crafted its advertising and public relations to avoid some of the less-favorable numbers surrounding Gardasil. The TV commercial says the vaccine "may help protect you" from HPV strains "that may cause 70% of cervical cancer." The company doesn't often discuss the lower efficacy against precancerous lesions or in populations where some women are already infected. The "one less" slogan avoids the question of how many lives will be saved.

Some Gardasil supporters funded by Merck are less careful about qualifying their claims. At the FDA advisory committee hearing, Martha Nolan, vice president of a women's health group that receives funds from Merck, said that by approving Gardasil, the agency had "the opportunity to eradicate this terrible disease."

After the FDA approval, a group of female state legislators called Women in Government started a campaign to get states to mandate vaccinations. The group receives money from Merck but won't say how much. Many of the pending bills would allow parents to keep their children out of the vaccination program, but only after submitting proof that they have received information about cervical cancer and the vaccine.

In early January, Women in Government held a conference for some 60 state legislators in Marco Island, Fla., paying for their airfare and hotel rooms. One of the speakers was Christine Baze, a pop singer and cervical-cancer survivor. As she performed songs on the piano, Ms. Baze told the story of her battle with the disease and said she wished a vaccine had been available to her. Ms. Baze says Women in Government paid her a $2,500 fee and covered her travel and lodging. She says she didn't receive any money from Merck for the appearance, but the company has paid her $7,500 to speak at three other events.

Marilyn Canavan, a representative in the Maine assembly who attended the conference, says she was bothered by the large number of drug-industry lobbyists she saw. A list of conference participants shows that 30 pharmaceutical-industry representatives were present -- one for every two state legislators. Merck had two representatives there. Ms. Canavan has since resigned her post as Women in Government's director in Maine over concerns that the group's agenda is being dictated by drug companies. Susan Crosby, Women in Government's president, says those concerns are unfounded.

Other state lawmakers came away from the conference inspired. Upon returning home, Jessica Sibley Upshaw, a representative in the Mississippi assembly, drafted a bill that would make vaccination a school requirement. "For me, it's a common-sense thing to do if we can eradicate a disease," she says. Ms. Upshaw's bill has since died, but she plans to reintroduce it.

Sparking an Uproar

In February, Texas Gov. Rick Perry bypassed the state legislature and issued an executive order mandating that all girls entering the sixth grade be vaccinated as of September 2008. One of Merck's lobbyists in Texas is Mike Toomey, Gov. Perry's former chief of staff, and Merck contributed $6,000 to the governor's re-election campaign. Mr. Toomey didn't return calls and emails seeking comment. A spokeswoman for the governor says he acted to protect the public's health, not because of the contribution or the lobbying of his former aide.

Gov. Perry's order sparked an uproar. Among the opponents are religious conservatives who say receiving the vaccine conflicts with their message of abstinence. Other opponents say Gardasil isn't worth the cost, which includes $360 for the vaccine and up to several hundred dollars more for three doctors' appointments to get the shots. The money would be better spent, these people say, in pushing Pap tests for women who aren't getting them now.

John Schiller, one of the National Cancer Institute scientists whose vaccine work was licensed by Merck, believes Gardasil is an important advance that should receive wide use, but he has mixed feelings about the way the company has promoted it. He hopes it won't divert public-health dollars away from regular Pap screening, which he says remains the most important weapon against cervical cancer. Merck "is a heavy-handed company," Dr. Schiller says. "When they do something, they spare no energy. It's the Merck way or the highway."

Merck says cost-effectiveness studies suggest the vaccine could deliver its life-saving benefits at a reasonable cost, in part by reducing the need for frequent Pap tests. Most of these studies have been funded by Merck and GlaxoSmithKline PLC, maker of another HPV vaccine, Cervarix. Glaxo applied for FDA approval of Cervarix last month.

One skeptic is Diane Harper, a longtime HPV researcher and professor at Dartmouth Medical School, who was involved in Gardasil's clinical trials and has received speaker and consulting fees from Merck and Glaxo. She says as many as 10% of 11- and 12-year-old girls may already have HPV, either from sexual activity, sexual abuse or transmission through nonsexual skin-to-skin contact. That could reduce the vaccine's efficacy, she says.

Dr. Harper also suspects the vaccine may require booster shots after 10 years. Merck says it's not sure how long the vaccine's protection will last and is monitoring women over the long term to find out.

The American Cancer Society, while agreeing with the CDC that girls should be vaccinated, said in January there is "insufficient evidence" that women age 19 to 26 will benefit from the vaccine because many have already been exposed to HPV.

Worried about the backlash that emerged in February in Texas and other states, Merck shifted into damage control. Richard Haupt, Merck's executive director of medical affairs, placed calls to respected figures in the vaccine field, including Jon Abramson, the chairman of the CDC's advisory committee on immunization practices, and Joseph Bocchini, chairman of the committee on infectious diseases at the American Academy of Pediatrics. Both men and others told Dr. Haupt they supported the vaccine, but it was too early and counterproductive to push for school requirements.

On Feb. 20, Merck announced that it was suspending its lobbying push, but Women in Government continues to lobby for school requirements. Virginia's mandate became law two weeks ago.

Write to John Carreyrou at john.carreyrou@wsj.com10

STATE BY STATE

The following states have introduced legislation on making cervical-cancer vaccinations a school requirement:
State Proposal Status
California Bill would have required girls entering the sixth grade to be vaccinated. Withdrawn for further consideration.
Colorado Bill would require 12-year-old girls to be vaccinated to attend school. Allows parents to opt their daughters out. Pending
Connecticut Bill would require girls receive a first dose of the vaccine before entering the sixth grade. Allows parents to opt their daughters out on medical or religious grounds. Pending
District of Columbia Bill would require girls to be vaccinated before they turn 13 to attend school. Allows parents to opt their daughters out. Pending
Florida Bill would have required 11- and 12-year-old girls to be vaccinated to attend school. Allows parents to opt their daughters out. Died in committee
Georgia Bill would require girls entering the sixth grade to be vaccinated unless parents can't afford the vaccine or object to it on medical or religious grounds. Pending
Illinois Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out. Pending
Kansas Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on medical or religious grounds. Pending
Kentucky Bill would require girls entering middle school to be vaccinated. Allows parents to opt their daughters out. Passed House, to Senate
Maryland Bill would have required girls entering the sixth grade to be vaccinated. Withdrawn
Massachusetts Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on religious grounds. Pending
Michigan Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out. Pending.
Missouri Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on medical or religious grounds. Pending
Minnesota Bill would require 12-year-old girls to be vaccinated to attend school. Allows parents to opt their daughters out. Pending
Mississippi Bill would have required girls entering the sixth grade to be vaccinated. Died. Sponsor planning to re-introduce it with an opt-out clause.
New Jersey Bill would require girls in grades seven through 12 to be vaccinated. Allows parents to opt their daughters out on medical or religious grounds. Pending
New Mexico Bill would require nine- to 14-year-old girls to be vaccinated to attend school. Allows parents to opt their daughters out. Passed legislature. Vetoed by governor.
Ohio Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out. Pending
Oklahoma Bill would require girls entering the sixth grade to be vaccinated. Pending
South Carolina Bill would require girls entering the seventh grade or 11 years of age to be vaccinated. Allows parents to opt their daughters out on medical or religious grounds. Pending
Texas Governor issued executive order requiring that girls entering the sixth grade be vaccinated. Allows parents to opt their daughters out. Bill overriding the executive order has passed the House and is pending in the Senate.
Vermont Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on medical, moral or religious grounds. Pending
Virginia Bill requires girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out. Passed the legislature. Goes into effect Oct. 1, 2008; to be implemented in fall of 2009.
West Virginia Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on medical grounds. Pending

Source: National Conference of State Legislatures, state legislatures
URL for this article:
http://online.wsj.com/article/SB117668541991270825.html

Hyperlinks in this Article:
(1) http://www.cdc.gov/mmwr/PDF/rr/rr5602.pdf
(2) http://www.cdc.gov/mmwr/PDF/rr/rr5602.pdf
(3) http://www.cdc.gov/nip/acip/slides/feb07/08-hpv-2-barr.pdf
(4) http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf
(5) http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4222t1.pdf
(6) http://blogs.wsj.com/health/2007/04/16/how-effective-is-mercks-hpv-vaccine/
(7) http://www.cdc.gov/nip/acip/slides/feb07/08-hpv-2-barr.pdf
(8) http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf
(9) http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4222t1.pdf
(10) mailto:john.carreyrou@wsj.com
Copyright 2007 Dow Jones & Company, Inc. All Rights Reserved

Wednesday, April 04, 2007

Radiation by any name still promotes cancer

The shift to MRI, also a form of radiation, may be better than the current system, remembering that a tumour must be at least eight years old before mammography will detect it in most cases.

I have spoken against the 'enhanced digital imaging' from the time it was proposed as an ineffective method of detecting tumours.

Thermography is the best choice for early and effective detection of tumours and it is not cancer causing. Ultrasound is effective too.

Read more here and here

Computers hinder mammogram readings, report finds
By Gene Emery, Reuters 4 April 07

Computer-aided mammogram designed to help doctors spot cancer do not increase the chance of finding a tumor and, instead, heighten the risk that a woman will get an unnecessary biopsy, researchers reported on Wednesday.

"This study points out the need for the use of other techniques to find cancer at its earliest stages," said Dr. John Niederhuber, director of the National Cancer Institute, which helped pay for the study.

Dr. Joshua Fenton of the University of California, Davis, and colleagues studied more than 429,000 mammograms for their study, published in the New England Journal of Medicine.

About 24 million screening mammograms are taken in the U.S. each year. "We would guess maybe 25 to 30 percent of facilities have adopted this, maybe more in urban centers where they have a high volume," said Fenton.

The results "constitute a substantial hit to this technology" and will "surprise and disappoint" most doctors who read mammograms, Dr. Ferris Hall of Beth Israel Deaconess Medical Center, wrote in a commentary.

Hall said Medicare pays an extra $20 for mammograms that are read by computer, a financial incentive that "was mandated by a heavily lobbied Congress, despite little evidence-based data in support of its value at the time."

Complicating the issue is the fact that the field is changing so quickly, further research may not be practical, he said. "Such studies will be expensive, controversial, indeterminate, or quickly passe owing to the emergence of new technology," Hall wrote.

Three such computer-aided devices, costing $160,000 to $240,000, have been approved by the U.S. Food and Drug Administration.

Most of the facilities in the Fenton study used units from R2 Technology Inc. of Santa Clara, Calif. the first to get FDA approval, in 1998. R2 is owned by Hologic Inc..

Kodak and iCAD Inc., of Nashua, N.H., also make units.

The research team used mammograms taken from 1998 to 2002 at 43 medical facilities in three states, seven of which switched to computer-aided detection in the middle of the study.

With human-read mammograms, 98 out of every 1,000 women were mistakenly told they were free of cancer. When the readings were done with the help of a computer, that number rose to 128 out of 1,000, without significantly increasing the number of tumors that were spotted by X-ray.

In addition, the researchers said the computer programs tended to focus on the least-dangerous types of cancers.

"There was no clear benefit in terms of breast cancer detection," Fenton said in a telephone interview.

The researchers also estimated that if every medical center used computer-assisted detection, it would cost the U.S. health care system an extra $550 million, an increase of 18 percent in the cost of doing breast cancer screening exams.

There is a lot of pressure to improve detection.

Hall said missed tumors are the most common source of lawsuits against radiologists, and in as many as half of all cancer cases, doctors turned out to have missed the tumor in an earlier mammogram. And with many medical students avoiding the field because of the stress, there is a shortage of good mammographers.

Hall said one alternative would be magnetic resonance imaging. Although it may detect 10 times as many cancers than mammography or physical examination, it is also 10 times more expensive.

"In certain populations of women, MRIs are much more sensitive to picking up cancers than mammography," said the chairwoman of the American Cancer Society's Breast Cancer Advisory Group, Dr. Christy Russell.

For those women, the chance of an MRI finding a tumor is 70 percent or higher, compared to just 30 percent for mammography or ultrasound, she said.

Sunday, April 01, 2007

Hillary's Heist

Seems as Mrs. Clinton is on a cash roll in fundraising lately.

But, please do remember that Bill Clinton brought you NAFTA.

NAFTA and GATT opened the door to sending all the good paying manufacturing jobs elsewhere. It also led the way to the requirement accepting unregulated products and ingredients imported from other places around the world. These ingredients recently found their wayr into pet food that recently took the lives of beloved animal companions.

Go back and look Hillary's health care proposal too if you think the wool might be pulling down over your eyes.

ASPARTAME BANNED IN THE PHILIPPINES

What New Mexico refused to do to protect its citizens from the known damage of aspartame has now become law in the Philippines.

from the Ministry of Industry, Tourism and Commerce (Spain)

Philippines forbids the import and use of aspartame

A law promulgated by the Philippine congress has forbidden the importing and use, in the country, of aspartame, a sweetener that is between 180 to 200 times more potent than sugar, as well as banning distribution of four makes of saccharine, the most important brand names in the country known as: Equal, NutraSweet, Equal-Measure y
Spoonful.[*]

According to the said Law aspartame gives rise to a total of 75% of the negative effects reflected in consumers and other users according to the north American administration of food and alimentation, among others, brain tumours, multiple sclerosis, epilepsy, Chronic Fatigue Syndrome, Parkinsons, Alzheimers and
diabetes among others.

The ban affects all use of this product in any type of consumable and infringement will carry penalties that go from 9,000 euros to 90,000 euros.

Spanish Institute of External Commerce (ICEX). Paseo de la Castellana 14-16, 28046 MADRID. | 902 349 000

[*] All these are the brand names for aspartame. Aspartame is listed as E951 in the Codex Alimentarius.

Filipinas prohbe la importacin y uso del aspartamo

Una ley promulgado por el congreso de Filipinas ha prohibido la
importacin y el uso del aspartamo, un edulcorante entre 180 y 200
veces ms potente que el azcar, en el pas, as como ha prohibido la
distribucin de cuatro marcas de sacarina, de las ms importantes del
pas: Equal, Nutrasweet, Equal-Measure y Spoonful.[*] Segn dicha ley
el aspartamo da lugar a un total del 75% de los efectos negativos
reflejados por los consumidores y usuarios segn la administracin
norteamericana de comida y alimentacin, entre otros, tumores
cerebrales, esclerosis mltiple, epilepsia, sndrome de fatiga crnica,
parkinson, alzheimer y diabetes entre otros. La prohibicin afecta al
uso de este producto en cualquier tipo de consumible y la vulneracin
de la misma acarrear penas que van desde los 9.000 euros a los 90.000
euros.

Instituto Espaol de Comercio Exterior (ICEX). P de la Castellana
14-16 28046 MADRID | 902 349 000

[*] Todas estas marcas son de aspartamo. Aspartamo se encuentra en
el Codex Alimentarius bajo el nmero E951.

http://www.icex.es/icex/cda/controller/page/0,2956,35582_13637_16030_298341,00.html

Monday, March 26, 2007

Dear Mrs. Edwards...

This is an open letter to Senator John and Mrs. Edwards -

Elizabeth, I am thinking about you and your family today. This is just as I do every day when I think of those with cancer whom I serve as a health advisor.

I am a medically trained health professional with over thirty years of experience. I have seen many people die of cancer and know that often this does not have to be the accepted end.

I am also an expert in natural health care, studying and using it for 50 years.

Right now I work with someone who has 'leukemia', most likely the result of the extreme benzene exposure he had while making the tires our cars and trucks ride on every day.

The other is the mother-in-law of a dear freind who recently was diagnosed with stomach cancer. She has been taking the 'purple' pill on her doctor's order for well over a year because of indigestion. Now she has stomach cancer and is told she has but a few months to live. The 'purple pill' is known to interfere with the P450 cytochrome pathway, a detoxification pathway that helps you retain your health.

Mrs. Edwards, I highly respect your decision to "live with cancer" and to work with your chosen route of treatment and your doctors prescribed treatment.

I am sad because it seems you drink diet soda frequently when it is well established scientifically that aspartame causes cancer (known to the FDA as well).

You may even eat 'yoplait', a toxic mixture of unhealthy ingredients passed off as yogurt. As some one said to me at a talk I gave recently to a breast cancer survivor's group, "they support breast cancer researh". They may to some, but our health education-public health-non-profit organization does not get a penney from General Mills. We at CHI really need support because the demand we get from people for help (especially those with low income) is much greater than out finances can support. Perhaps this is because I learned that cancer would be cured by 1972 and am wondering what happened and why the incidence keeps climbing.

I am sad because I know the science behind the increase rate of breast cancer from mammography and the added cumulative damage from radiation treatment.

I am sad because I know the damage of chemotherapy drugs and that manistream medicine does not allow any adjunct treatment to detoxify the body from the 'die-off' of caner cells in this treatment, unlike natural care.

I am sad because Senator Kennedy's son had some natural treatment for his bone cancer and you may not know of it.

I am sad too because you do not consider proven intravenous vitamin C therapy that has cured cancer (see this same blog for more information), or the Kelley method that some of my clients choose - and that FDA studies show has an 83% cure rate, or the Burzynsky treatment that is effective also. This is in addition to other natural methods that have been used in conjunction with chemotherapy by enlightened medical doctors such as Laetrile, Hoxsey or Essiac herbal extracts.

Even the much maligned 'zapper' is proven at the University of WA to kill cancer cells.

There is so much more you can really do.

I wish that my thoughts reach you in some way, should the universe and it's Creator deem.

Sending you love, light and healing,
Dr. Gayle

and today (27 March) this same message goes to Tony Snow and all of the people everywhere 'living with cancer' and searching for options.

A reason to consider (and demand) effective natural treatment

Cayenne, hawthorne berry, white willow bark, natural vitamin E, chelation, IV vitamin c and other scientifically supported natural treatments can and will help you prevent the risk of heart disease without risky (yes! angioplasty can kill you) and expensive surgical treatments.
------------------------------------------------------------------------------------
Most angioplasties unneeded, study finds

By MARILYNN MARCHIONE, AP Medical Writer1 hour, 2 minutes ago

More than half a million people a year with chest pain are getting an unnecessary or premature procedure to unclog their arteries because drugs are just as effective, suggests a landmark study that challenges one of the most common practices in heart care.

The stunning results found that angioplasty did not save lives or prevent heart attacks in non-emergency heart patients.

An even bigger surprise: Angioplasty gave only slight and temporary relief from chest pain, the main reason it is done.

"By five years, there was really no significant difference" in symptoms, said Dr. William Boden of Buffalo General Hospital in New York. "Few would have expected such results."

He led the study and gave results Monday at a meeting of the American College of Cardiology. They also were published online by the New England Journal of Medicine and will be in the April 12 issue.

Angioplasty remains the top treatment for people having a heart attack or hospitalized with worsening symptoms. But most angioplasties are done on a non-emergency basis, to relieve chest pain caused by clogged arteries crimping the heart's blood supply.

Those patients now should try drugs first, experts say. If that does not help, they can consider angioplasty or bypass surgery, which unlike angioplasty, does save lives, prevent heart attacks and give lasting chest pain relief.

In the study, only one-third of the people treated with drugs ultimately needed angioplasty or a bypass.

"You are not putting yourself at risk of death or heart attack if you defer," and considering the safety worries about heart stents used to keep arteries open after angioplasty, it may be wise to wait, said Dr. Steven Nissen, a Cleveland Clinic heart specialist and president of the College of Cardiology.

Why did angioplasty not help more?

It fixes only one blockage at a time whereas drugs affect all the arteries, experts said. Also, the clogs treated with angioplasty are not the really dangerous kind.

"Even though it goes against intuition, the blockages that are severe that cause chest pain are less likely to be the source of a heart attack than segments in the artery that are not severely blocked," said Dr. David Maron, a Vanderbilt University cardiologist who helped lead the new study.

Drugs are better today than they used to be, and do a surprisingly good job, said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute.

"It may not be as bad as we thought" to leave the artery alone, she said.

About 1.2 million angioplasties are done in the United States each year. Through a blood vessel in the groin, doctors snake a tube to a blocked heart artery. A tiny balloon is inflated to flatten the clog and a mesh scaffold stent is usually placed.

The procedure already has lost some popularity because of emerging evidence that popular drug-coated stents can raise the risk of blood clots months later. The new study shifts the argument from which type of stent to use to whether to do the procedure at all.

It involved 2,287 patients throughout the U.S. and Canada who had substantial blockages, typically in two arteries, but were medically stable. They had an average of 10 chest pain episodes a week — moderately severe. About 40 percent had a prior heart attack.

"We deliberately chose to enroll a sicker, more symptomatic group" to give angioplasty a good chance to prove itself, Boden said.

All were treated with medicines that improve chest pain and heart and artery health such as aspirin, cholesterol-lowering statins, nitrates, ACE inhibitors, beta-blockers and calcium channel blockers. All also were counseled on healthy lifestyles — diet, exercise and smoking cessation.

Half of the participants also were assigned to get angioplasty.

After an average of 4 1/2 years, the groups had similar rates of death and heart attack: 211 in the angioplasty group and 202 in the medication group — about 19 percent of each.

Heart-related hospitalization rates were similar, too.

Neither treatment proved better for any subgroups like smokers, diabetics, or older or sicker people.

At the start of the study, 80 percent had chest pain. Three years into it, 72 percent of the angioplasty group was free of this symptom as was 67 percent of the drug group.

That means you would have to give angioplasties to 20 people for every one whose chest pain was better after three years — an unacceptably high ratio, Nissen said.

After five years, 74 percent of the angioplasty group and 72 percent of the medication group were free of chest pain - "no significant difference," Boden said.

The study was funded by the U.S. Department of Veterans Affairs, the Medical Research Council of Canada and a host of drug companies. Stent makers refused to help pay for the research, said scientists who led the study.

The study renewed a heated animosity between doctors who perform angioplasty and other heart specialists.

In fact, one who does the procedures and who spoke at a meeting in New Orleans sponsored by stent maker Boston Scientific Corp. was responsible for the early release of the study's results, which were not due out until Tuesday.

The study "was rigged to fail, and it did," the Wall Street Journal quoted Dr. Martin B. Leon of Columbia University telling several hundred of his colleagues Sunday night.

"A lot of people have been taking shots at us, and we need to go on the offense for awhile," the Journal reported Leon said.

He claimed to have inside knowledge of the results because he reviewed the study for the New England Journal. The journal would not comment, saying the identity of its reviewers is confidential.

The cardiology college issued a statement saying it was "extremely disappointed" results were released prematurely, "betraying the confidentiality of the scholarly process and the professional integrity of the scientific community."

The college "will be considering strong sanctions against the individual or individuals involved," the statement said.

Boston Scientific shares fell $1.05, or 6.6 percent, to close at $14.22 on the New York Stock Exchange at double their average volume.

Dr. Spencer King of Piedmont Hospital in Atlanta, a leading cardiologist who does many angioplasties, said he was disappointed in the study results.

"How many patients have interventions in which the only expectation is to reduce the use of nitroglycerin or to walk a bit faster? Most patients anticipate a better prognosis and might opt for an extended course of medical therapy if they believe they are not putting their life at excess risk," he wrote in a recent editorial in an American Heart Association journal.

In an interview at the cardiology meeting, King said he recently had surgery for back pain and did not expect permanent relief but added, "If it only held up for five years, I wouldn't be happy about it."

The new study "should lead to changes in the treatment of patients with stable coronary artery disease, with expected substantial health care savings," Dr. Judith Hochman of New York University wrote in an editorial in the journal.

An angioplasty costs roughly $40,000. The drugs used in the study are almost all available in generic form.

Maron, the Vanderbilt doctor who helped lead the study, said people should give the drugs a chance.

"Often I think that patients are under the impression that unless they have that procedure done, they're not getting the best of care and are at increased risk of having a heart attack and die," he said.

Dr. Raymond Gibbons, a Mayo Clinic cardiologist and American Heart Association president, agreed: "This trial shows convincingly that that assumption is incorrect."

New England Journal: http://www.nejm.org
Heart meeting: http://www.acc.org
------------------------------------------------------------------------------------
Stent use in heart disease treatment does not reduce mortality: study
by Jean-Louis Santini, 26 March 07

The use of stents in obstructed arteries, a widespread and lucrative heart disease treatment, does not reduce mortality in stable patients, a study released Monday found.

The results, released at a gathering of the American College of Cardiology (ACC), looked at the use of stents to reduce mortality compared to use of drugs alone, and could encourage a major shift in the way physicians treat heart disease patients.

The finding could rock a six-billion-dollar a year industry, 3.2 billion dollars of which is done in the United States.

US-based Johnson and Johnson and Boston Scientific are the top manufacturers of the devices.

"As an initial management strategy in patients with stable coronary artery disease, percutaneous coronary intervention (PCI, or stent insertion) did not reduce the risk of death, myocardial infarction, or other major cardio-vascular events when added to optimal medical therapy," write the authors of the study due to appear in the March 29 issue of the New England Journal of Medicine.

The mortality rate was around eight percent in both groups at the end of the study. Related risks such as death, heart attack and other cardiovascular incidents, were 20 percent and 19.5 percent, respectively, a statistically negligible difference.

Dubbed the Courage trial (Clinical Outcome Utilizing Revascularization and Aggressive Drug Evaluation), its results "should lead to changes in the treatment of patients with stable coronary artery disease, with expected substantial health care savings," wrote cardiologists Judith Hochman and Gabriel Steg in an editorial in the same edition of the New England Journal of Medicine.

"PCI has an established place in treating angina but is not superior to intensive medical therapy to prevent myocardial infarction and death...in patients such as those in the study," they added.

Lead author William Boden added that "percutaneous coronary intervention (PCI) is critically important in terms of reducing death, improving survival in patients with acute myocardial infarction; it's the procedure of choice, in that minority of patients, PCI is beneficial and life saving.

"But it's not in the great majority of patients with symptomatic coronary artery disease," Boden stressed.

"I think the results of COURAGE are good news for patients and physicians because now we have a base for adoption of a treatment," he added, noting that "historically, there has been an unproven assumption that if you have a significant a coronary diseases, you must have PCI."

More than one million stent procedures were done in 2004 and 85 percent of them were stable patients, according to the study's authors.

The study was done with 2,287 heart disease patients in Canada and the United States between 1999 and 2004. Half received stents and half drug treatment alone. The study was funded among others by the Department of Veterans Affairs, the Canadian Institute for Health Research and pharmaceutical firms such as Merck, Pfizer and Sanofi.

More than 70 million Americans suffer from cardiovascular disease the leading cause of death in the United States, with more than 900,000 deaths in 2005.

Worldwide cardiovascular disease caused 17.5 million deaths the same year, 30 percent of the total, according to data from the World Health Organization.

Copyright © 2007 Agence France Presse.

Drugs for 'good' cholesterol fail tests

So what do they expect? Cholesterol drugs are known to be extremely hazardous and may cost you your life. Why play Russian Roulette with all the barrel loaded by taking these drugs on the false promise that cholesterol is hazardous?

Try one tablespoon a day of high quality, cold and first pressed extra virgin olive oil from a glass bottle. Add a teaspoon or two of raw apple cider vinegar in your glass of pure and fluoride free water daily and throw in some good vitamin C and niacin. Might be easier, less expensive and life altering.

Yoda
---------------------------------------------------------------------------------------

By MARILYNN MARCHIONE, AP Medical Writer

The hot new strategy of trying to prevent heart disease by raising good cholesterol had more setbacks Monday as new studies showed that experimental drugs didn't work and also had safety problems.

The news follows Pfizer Inc.'s abandonment in December of an $800 million investment in torcetrapib, the leading contender in this class of drugs, because it raised the risk of heart attacks and deaths.

Heart specialists have been anxious to know whether the problems extend to all such drugs and doom this approach.

"A lot of people think it's the next big thing, and we'll need to understand what went wrong with torcetrapib to move forward," said Dr. Steven Nissen, a Cleveland Clinic heart specialist who is president of the American College of Cardiology.

The new studies, reported at the group's conference, gave a mixed answer. The Pfizer drug seems uniquely risky, but other drugs have problems, too.

And even though they and the Pfizer drug raised HDL good cholesterol as intended, that made no difference in the odds of heart attacks or deaths, or key measures of cholesterol buildup in arteries.

Doctors long have focused on lowering LDL, or bad cholesterol, to cut heart attack risk. Statins, sold as Lipitor and Zocor and also in generic form, lower LDL, which ferries fats from food into the bloodstream.

But many statin users suffer heart attacks anyway, so doctors have been trying to boost HDL, or good cholesterol — which transports fat from the blood to the liver to be disposed of — to further lower risk.

An extended-release niacin drug called Niaspan, sold by Kos Pharmaceuticals Inc., does this. But it can cause a prickly hot sensation called flushing that some people find intolerable. Pfizer, Merck & Co. and Swiss drug maker Roche Holding AG are testing drugs that boost HDL in a novel way.

On Monday, scientists reported the results of several studies on torcetrapib. In one, the drug boosted HDL by 61 percent, but trends in death, hospitalization and heart attacks "are all going in the wrong direction," Nissen said.

An experimental diabetes drug by Eli Lilly and Co. that is 10,000 times more potent than fibrates, a current cholesterol treatment, also proved disappointing. The new drug raised HDL but also raised the risk of kidney, heart and other serious problems, Nissen reported.

Finally, infusions of a reconstituted form of HDL developed by CSL Ltd., an Australian company, made no big difference in the burden of artery buildups in a study led by Dr. Jean-Claude Tardif of the Montreal Heart Institute.

In several of these studies there were hints of some improvements in less important measures of artery buildup, which provides "a glimmer of hope for future development of this class of drugs," Dr. Alan Tall of Columbia University writes in an editorial in the New England Journal of Medicine.

That journal and the Journal of the American Medical Association published several of the new studies.

"The bar has been raised a lot for this entire class, but I do not think we can abandon this entire approach," Nissen said.

If Baycol had been the first statin tested and research had stopped after safety problems emerged, there wouldn't even be this class of drugs, he noted. Baycol, sold by Bayer AG, was withdrawn from the market in 2001 after reports of a severe and sometimes fatal muscle disorder.

Monday, March 05, 2007

America's Favorite 'Health' Food Maybe Shouldn't Be: Just A Reminder

The DARK Side Of Soy -

Over the past decade, soy foods have become America's favorite health food. Newspapers, magazines, and best-selling health writers have proclaimed the "joy of soy" and promoted the belief that soy food is the key to disease prevention and maximum longevity.

The possibility that an inexpensive plant food could prevent heart disease, fight cancer, fan away hot flashes, and build strong bodies in far more than 12 ways is seductive. The truth, unfortunately, is far more complex. Soy foods come in a variety of forms, including many heavily processed modern products. Even good forms of soy foods must be eaten sparingly-the way they have been eaten traditionally in Asia. Most important, many respected scientists have issued warnings stating that the possible benefits of eating soy should be weighed against the proven risks. Indeed, thousands of studies link soy to malnutrition, digestive distress, immune-system breakdown, thyroid dysfunction, cognitive decline, reproductive disorders and infertility-even cancer and heart disease.

Americans rarely hear anything negative about soy. Thanks to the shrewd public relations campaigns waged by Archer Daniels Midland (ADM), Protein Technologies International (PTI), the American Soybean Association, and other soy interests, as well as the Food and Drug Administration's (FDA) 1999 approval of the health claim that soy protein lowers cholesterol, soy maintains a "healthy" image.

This article is written for parents who need to know the risks of feeding soy formula to infants, or soy milk and other soy foods to growing children. It's designed for prospective mothers and fathers who need to know the links between soy foods, infertility, and birth defects. Finally, it will serve anyone considering soy as a preventive for menopausal symptoms, osteoporosis, cancer, heart disease, or other ills.

How Much Soy Do Asians Really Eat?
Those who dare to question the benefits of soy tend to receive one stock answer: Soy foods couldn't possibly have a downside because Asians eat large quantities of soy every day and consequently remain free of most western diseases. In fact, the people of China, Japan, and other countries in Asia eat very little soy. The soy industry's own figures show that soy consumption in China, Indonesia, Korea, Japan, and Taiwan ranges from 9.3 to 36 grams per day.1 That's grams of soy food, not grams of soy protein alone. Compare this with a cup of tofu (252 grams) or soy milk (240 grams).2 Many Americans today think nothing of consuming a cup of tofu, a couple glasses of soy milk, handfuls of soy nuts, soy "energy bars," and veggie burgers. Infants on soy formula receive the most of all, both in quantity and in proportion to body weight.

In short, there is no historical precedent for eating the large amounts of soy food now being consumed by infants fed soy formula and vegetarians who favor soy as their main source of protein, or for the large amounts of soy being recommended by Dr. Andrew Weil, Dr. Christiane Northrup, and many other popular health experts.

What's more, the rural poor in China have never seen-let alone feasted on-soy sausages, chili made with Textured Vegetable Protein (TVP), tofu cheesecake, packaged soy milk, soy "energy bars," or other newfangled soy products that have infiltrated the American marketplace.

The Right Stuff
The ancient Chinese honored the soybean with the name "the yellow jewel" but used it as "green manure"-a cover crop plowed under to enrich the soil. Soy did not become human food until late in the Chou Dynasty (1134-246 B.C.), when the Chinese developed a fermentation process to make soybean paste, best known today by its Japanese name, miso.3 Soy sauce-the natural type sold under the Japanese name shoyu-began as the liquid poured off during the production of miso. Two other popular fermented soy foods, natto and tempeh, entered the food supply around 1000 A.D. or later in Japan and Indonesia, respectively.

Tofu came after miso. Legend has it that, in 164 B.C., Lord Liu An of Huai-nan, China-a renowned alchemist, meditator, and ruler-discovered that a purée of cooked soybeans could be precipitated with nigari (a form of magnesium chloride found in seawater) into solid cakes, called tofu. In Japan, as in China, tofu was rarely served as a main course anywhere except in monasteries. Its most popular use was-and is-as a few bland little blocks in miso soup or fish stock.

The Chinese almost never ate boiled or baked soybeans or cooked with soy flour except in times of famine. Modern soy products such as soy protein isolate (SPI), TVP, soy-protein concentrate, and other soy-protein products made using high-tech industrial processes, were unknown in Asia until after World War II.4

Contrary to popular belief, neither soy milk nor soy infant formula is traditional in Asia. Soy milk originated as a byproduct of the process of making tofu; the earliest reference to it as a beverage appeared in 1866.5 By the 1920s and 1930s, it was popular in Asia as an occasional drink served to the elderly.6-8 The first person to manufacture soy milk in China was actually an American-Harry Miller, a Seventh Day Adventist physician and missionary.9

The first soy infant formulas in China were developed in the 1930s and have never been widely used.10-14 Today, babies in Asia are almost always breastfed for at least the first six months, then switched to a dairy-based infant formula. Orphans and others who cannot be breastfed by a wet nurse are fed from birth on dairy formulas.15

Claims that soybeans have been a major part of the Asian diet for more than 3,000 years, or from "time immemorial," are simply not true.

Processing Matters
Soy in the West has been a product of the industrial revolution-an opportunity for technologists to develop cheap meat substitutes, to find clever new ways to hide soy in familiar food products, to formulate soy-based pharmaceuticals, and to develop a renewable, plant-based resource that could replace petroleum-based plastics and fuels.

For years, the soy protein left over from soy-oil extraction went to animals and poultry. Now that food scientists have discovered inexpensive ways to improve or disguise the color, flavor, "bite characteristics," and "mouth feel" of soy protein-based products, soy is being aggressively marketed as a "people feed." Although the newer refining techniques yield blander, purer soy proteins than the "beany," hard-to-cover-up flavors of the past, the main reason that soy foods now taste and look better is the lavish use of unhealthy additives such as sugar and other sweeteners, salt, artificial flavorings, colors, and monosodium glutamate (MSG).

Soy now lurks in nearly 60 percent of the foods sold in supermarkets and natural food stores. Much of this is "hidden" in products where it wouldn't ordinarily be expected, such as fast-food burgers and Bumblebee canned tuna. Soy is also a key ingredient in ersatz products with names like Soysage, Not Dogs, Fakin Bakin, Sham Ham, and TofuRella, which have been named after and made to look like the familiar meat and diary products they are intended to replace.

There's nothing natural about these modern soy protein products. Textured soy protein, for example, is made by forcing defatted soy flour through a machine called an extruder under conditions of such extreme heat and pressure that the very structure of the soy protein is changed. Production differs little from the extrusion technology used to produce starch-based packing materials, fiber-based industrial products, and plastic toy parts, bowls, and plates.16

The process of making soy protein isolate (SPI) begins with defatted soybean meal, which is mixed with a caustic alkaline solution to remove the fiber, then washed in an acid solution to precipitate out the protein. The protein curds are then dipped into another alkaline solution and spray-dried at extremely high temperatures. SPI is then often spun into protein fibers using technology borrowed from the textile industry. These refining processes remove "off flavors," "beany" tastes, and some of the worst flatulence-producing components. They improve digestibility, but vitamin, mineral, and protein quality are sacrificed, and levels of carcinogens such as nitrosamines are increased.17-22 SPIs appear in so many products that consumers would never guess that the Federation of American Societies for Experimental Biology (FASEB) decreed in 1979 that the only safe use for SPIs was for sealers for cardboard packages.23

Antinutrients and Toxins in Soy
Scientists who have studied the use of soy protein in animal feeds over the years have discovered a number of components in soy that cause poor growth, digestive distress, and other health problems.24-27 To list just a few of these: Protease inhibitors interfere with protein digestion and have caused malnutrition, poor growth, digestive distress, and pancreatitis.28 Phytates block mineral absorption, causing zinc, iron, and calcium deficiencies.29-34 Lectins and saponins have caused leaky gut and other gastrointestinal and immune problems.35-36 Oxalates-surprisingly high in soy-may cause problems for people prone to kidney stones and women suffering from vulvodynia, a painful condition marked by burning, stinging, and itching of the external genitalia.37, 38 Finally, oligosaccharides give soy its notorious reputation as a gas producer. Although these are present in all beans, soy is such a powerful "musical fruit" that the soy industry has identified "the flatulence factor" as a major obstacle that must be overcome for soy to achieve full consumer acceptance.39, 40

Apologists for soy dismiss such claims, saying that food processing and home cooking remove most of these antinutrients. In fact, modern processing removes most of them, but not all. The levels of heat and pressure needed to remove all protease inhibitors, for example, severely damage soy protein and make it harder to digest. The trick is to eliminate the most antinutrients while doing the least damage to the soy protein. Success varies widely from batch to batch.41-44

For years, the soy industry tried to improve the quality of animal feeds by finding better ways to get rid of these undesirable antinutrients. Having failed, they routinely supplement animal feeds heavily with vitamins, minerals, and methionine, a sulfur-containing amino acid that is low in soy. Even so, makers of animal chows are still limited in the amount of soy they can add without causing growth and fertility problems. Food processors making soy-protein products for people may or may not add these supplements. Generally, calcium and vitamin D are added to soy milk so it can compete with dairy products.

Today, the soy industry has switched tactics-from trying to remove unwanted antinutrients to trying to convince people that they are actually a good thing. Protease inhibitors, saponins, and lectins are being touted as curers of cancer or lowerers of cholesterol, while phytates are being recommended for their ability to remove toxic minerals such as cadmium and excess iron from the body.45-51 Although some of these uses look promising, it is important to note that researchers are not achieving these successes using regular soy foods. Most take carefully extracted components and administer them in carefully measured and monitored pharmaceutical doses. News headlines to the contrary, there is no reason to think that just eating a lot of soy foods will do the trick.

Soy Allergens
Soy is one of the top eight allergens that cause immediate hypersensitivity reactions such as coughing, sneezing, runny nose, hives, diarrhea, difficulty swallowing, and anaphylactic shock. Delayed allergic responses are even more common and occur anywhere from several hours to several days after the food is eaten. These have been linked to sleep disturbances, bedwetting, sinus and ear infections, crankiness, joint paint, chronic fatigue, gastrointestinal woes, and other mysterious symptoms.52, 53

Soy allergies are on the rise for three reasons: the growing use of soy infant formula (now 20 to 25 percent of the formula market), the increase in soy-containing foods in grocery stores, the possibility of the greater allergenicity of genetically modified soybeans.54 Although severe reactions to soy are rare compared to reactions to peanuts, tree nuts, fish, and shellfish, soy has been underestimated as a cause of food anaphylaxis. Recently, after a young girl in Sweden suffered an asthma attack and died after eating a hamburger that contained only 2.2 percent soy protein, Swedish researchers looked into a possible soybean connection. They concluded that the soy-in-the-hamburger case was not a fluke, and that minute amounts of soy "hidden" in regular food had caused four of the total of five deaths caused by allergic reactions in Sweden between 1993 and 1996. Of the children who suffered fatal attacks, all had been able to eat soy without any adverse reactions right up until the dinner that caused their deaths.55 According to the Swedish Ministry of Health and Social Affairs, children at highest risk are those who suffer from peanut allergies and asthma; parents of such children should make every effort to eliminate all soy from their children's diets.56

Soy and the Thyroid: A Pain in the Neck
More than 70 years of human, animal, and laboratory studies show that soybeans put the thyroid at risk. The chief culprits are the plant hormones in soy known as phytoestrogens or isoflavones.57-59 The United Kingdom's Committee on Toxicology has identified several populations at special risk: infants on soy formula, vegans who use soy as their principal meat and dairy replacements, and men and women who self-medicate with soy foods and/or isoflavone supplements in an attempt to prevent or reverse menopausal symptoms, cancer, or heart disease.60

Infants with congenital hypothyroidism need 18 to 25 percent higher doses of thyroxine drug than usual if they are bottle-fed with soy formula.61 Likewise, adults who boost their thyroid with drugs such as Synthroid while also eating thyroid-inhibiting foods such as soy put extreme stress on their thyroids. Toxicologist Michael Fitzpatrick, PhD, points out that this is the way that researchers induce thyroid cancers in laboratory animals.62

Soy and Reproduction: Breeding Discontent
Scientists have known since the mid-1940s that phytoestrogens can impair fertility. Fertility problems in cows, sheep, rabbits, cheetahs, guinea pigs, birds, and mice have all been reported.63, 64 Although scientists discovered only recently that soy lowers testosterone levels,65 tofu has traditionally been used in Buddhist monasteries to decrease the libido, and by Japanese women to punish straying husbands. Humans and animals appear to be the most vulnerable to the effects of soy estrogens prenatally, during infancy and puberty, during pregnancy and lactation, and during the hormonal shifts of menopause. Of all these groups, infants on soy formula are at the highest risk because of their small size and developmental phase, and because formula is their main source of nutrient.66, 67

A crucial time for the programming of the human reproduction system is right after birth-the very time when bottles of soy formula are given to many non-breastfed babies. Normally during this period, the body surges with natural estrogens, testosterones, and other hormones that are meant to program the baby's reproductive development from infancy through puberty and into adulthood. For infants on soy formula, this programming may be interrupted.68-70

Male infants experience a testosterone surge during the first few months of life and produce androgens in amounts equal to those of adult men. So much testosterone at such a tender age is needed to program the body for puberty, the time when a male's sex organs should develop and he should begin to express male characteristics such as facial and pubic hair and a deep voice. If receptor sites intended for the hormone testosterone are occupied by soy estrogens, however, appropriate development may never take place.71-74 To date, most of the evidence damning soy formula can be found only in animal studies, because investigations in which humans' sex hormone levels are lowered experimentally cannot ethically be done. However, in the years since soy formula has been in the marketplace, parents and pediatricians have reported growing numbers of boys whose physical maturation is either delayed or does not occur at all. Breasts, underdeveloped gonads, undescended testicles (cryptorchidism), and steroid insufficiencies are increasingly common. Sperm counts are also falling.75-79

Soy formula is bad news for girls as well. Natural estrogen levels approximately double during the first month of life, then decline and remain at low levels until puberty. With increased estrogens in the environment in the diet, an alarming number of girls are entering puberty much earlier than normal.80-82 One percent of girls now show signs of puberty, such as breast development or pubic hair, before the age of three. By the age of eight, 14.7 percent of Caucasian girls and 48.3 percent of African American girls had one or both of these characteristics.83 The fact that blacks experience earlier puberties than whites is not a racial difference but a recent phenomenon.84, 85

Most experts blame this epidemic of "precocious puberty" on environmental estrogens from plastics, pesticides, commercial meats, etc., but some pediatric endocrinologists believe that soy is a contributor.86 Of all the estrogens found in the environment, soy is the likeliest explanation of why African American girls reach puberty so quickly. Since its establishment in 1974, the federal government's Women, Infants and Children (WIC) program has provided free infant formula to teenage and other low-income mothers while failing to encourage breastfeeding. Because of perceived or real lactose intolerance, black babies are much more likely to receive soy formula than Caucasian babies.

Early maturation in girls heralds reproductive problems later in life, including amenorrhea (failure to menstruate), anovulatory cycles (cycles in which no egg is released), impaired follicular development (follicles failing to mature and develop into healthy eggs), erratic hormonal surges, and other problems associated with infertility. Because the mammary glands depend on estrogen for their development and functioning, the presence of soy estrogens at a susceptible time might predispose girls to breast cancer, another condition that is on the rise and definitively linked to early puberty.87

Recently, a team of researchers headed by Brian L. Strom, MD, studied the use of soy formula and its long-term impact on reproductive health. They announced only one adverse finding: longer, more painful menstrual periods among women who'd been fed soy formula in infancy.88 Dr. Strom's conclusion that the results were "reassuring" made newspaper headlines all over the world, though the data in the body of the report were anything but. Indeed, data left out of the headlines and buried in the report revealed higher incidences of allergies and asthma, and higher rates of cervical cancer, polycystic ovarian syndrome, blocked fallopian tubes, and pelvic inflammatory disease.89 Although thyroid damage from soy formula has been the principal concern of critics for decades, the researchers excluded thyroid function as a subject for study. Not surprisingly, this study was funded in part by the infant-formula industry.

Most of the fears concerning soy formula have focused on estrogens. There are other problems as well, notably much higher levels of aluminum, fluoride, and manganese than are found in either breastmilk or dairy formulas.90-96 All three metals have the potential to adversely affect brain development. Although trace amounts of manganese are vital to the development of the brain, toxic levels accrued from ingestion of soy formula during infancy have been found in children suffering from attention-deficit disorders, dyslexia, and other learning problems.97, 98

Soy apologists sometimes argue that the plant hormones in soy formula could not possibly be harmful because Japanese women eat a lot of soy products and so must have high levels of phytoestrogens in their breastmilk. Researchers, however, have measured the soy isoflavones in breastmilk and found them low even in vegetarian women who consume copious quantities of tofu, soy milk, soy protein shakes, and other soy foods.99-101

Limited evidence, however, suggests that vegetarian women who eat a lot of soy foods during pregnancy may put their infants at risk in terms of their future reproductive health, fertility, and possibly increased risk of breast cancer. All of the problems that have befallen infants on soy formula, as well as estrogen-related birth defects, have occurred (in animal studies, at least) to the offspring of mothers who were given high doses of soy during pregnancy.102 One of these birth defects that has been linked to vegetarian diets in humans is hypospadias, a developmental disorder in which the opening of the penis is located on the underside of the shaft.103

Until soy estrogens are definitely linked to reproductive-tract abnormalities, infertility, and other health problems in humans, most health authorities recommend that we "wait and see." This could be a terrible mistake.

In the 1940s and 1950s, another estrogen, diethylstilbestrol (DES), was widely given to Western women early in their pregnancies in a misguided attempt to prevent miscarriage. That fact is relevant not only because DES bears a striking structural similarity to some plant estrogens-including soy isoflavones-but because it took more than 20 years before the full spectrum of harmful effects was observed.104, 105

DES is 100,000 times more potent than soy phytoestrogens. However, the large quantities of phytoestrogens in soy products are more than enough to counteract their lower potency. When the effects of isoflavones in fetal and neonatal animals have been studied, they have paralleled those observed in human infants exposed to DES.106, 107 Recent studies indicate that the soy isoflavone known as genistein may be even more carcinogenic than DES.108

Yet the belief persists that soy hormones are "safe" because they are "weak" and "natural." Although the soy industry has claimed that soy estrogens are anywhere from 10,000 to 1,000,000 times weaker than the human estrogen estradiol, the correct figure is only 1,200 times as weak.109 Though this still sounds quite weak, it is not-because of the quantity of these estrogens ingested by infants on soy formula, and by children and adults who eat soy every day. These individuals consume far more soy estrogens than were ever part of a traditional diet in Asia. The average isoflavones intake in China is 3 milligrams, or 0.05 mg per kilogram of body weight.

In Japan, the figures range from 10 to 28 mg, or 0.17 to 0.47 isoflavones per kg of body weight. In contrast, infants receiving soy formula average 38 mg of isoflavones, which comes to a shocking 6.25 mg/kg of body weight. Compare that dose to the 0.47 mg/kg per day fed to healthy Japanese adult men and women who experienced thyroid suppression after just three months-or to the 0.75 mg/kg of isoflavones fed to American women who experienced hormonal changes sufficient to skew their menstrual cycles after just one month.110 Although children and teenagers are less vulnerable than infants, their young bodies are still developing, and highly vulnerable to endocrine-system disruption by soy. And soy has been shown to pass through the placentas of pregnant women to their unborn babies.

Meanwhile, the jury is still out on whether soy might help alleviate menopausal symptoms or prevent osteoporosis and breast cancer. The soy industry's top scientists, convened at the Fifth International Symposium on the Role of Soy in the Preventing and Reversing Chronic Disease (held in Orlando, Florida, September 21-24, 2003), conceded that the data are confusing and contradictory, with some studies suggesting that soy might be helpful, and others showing that soy contributes to osteoporosis and promotes breast cancer.

What's certain is that the levels of soy estrogens that might possibly have a beneficial effect on hormonally related diseases have been proven to jeopardize the health of the thyroid. Likewise, the 25 grams of soy protein per day touted by the FDA to lower cholesterol (see sidebar, "Boon to the Industry: The FDA's Soy Protein Health Claim") is very likely to harm the thyroid, and thus increase one of the risk factors for heart disease.

The bottom line is that the safety of soy foods has yet to be proven, and that human beings have become guinea pigs in what Daniel M. Sheehan, formerly senior toxicologist with the FDA's National Center for Toxicological Research, has called a "large, uncontrolled and basically unmonitored human experiment."111

By Kaayla T. Daniel
2-26-7