Natural Communities Magazine A magazine devoted to the local natural wellness culture.

Archive for December, 2007

California Lindane Ban Proves Successful

Monday, December 31st, 2007

According to a study published December 11, 2007 in the online edition of Environmental Health Perspectives, banning lindane is a viable solution to protecting health and the environment without resulting in increasing problems with head lice and scabies. In 2002, California banned pharmaceutical use of lindane due to concerns about water quality, when high levels of this treatment for head lice and scabies were found to be impacting wastewater quality.

The study, “Outcomes of the California Ban on Pharmaceutical Lindane: Clinical and Ecologic Impacts,” describes the effects the ban has had on wastewater quality, unintentional exposures, and clinical practice. This is the first time that a pharmaceutical has been outlawed to protect water quality. As such, this ban provides a rare opportunity to evaluate the possible or potential outcomes of future public health interventions aimed at reducing pharmaceutical water contamination.

The study authors compiled data on lindane in wastewater treatment plant effluent for several large plants in California and one outside of California. Data on exposures to lindane were obtained from records of the California Poison Control System. The impact on clinical practice was assessed via a survey of 400 pediatricians.

Wastewater treatment plant monitoring showed that lindane declined in California after the ban. Similarly, unintentional exposure calls declined. Most physicians were aware of the ban (81%) and had used lindane previously (61%), but did not notice any difficulties with the ban (78%).

According to the study’s authors, the California experience suggests elimination of pharmaceutical lindane produced environmental benefits, was associated with a reduction in reported unintentional exposures and did not adversely affect head lice and scabies treatment. This ban serves as a model for governing bodies considering limits on the use of lindane or other pharmaceuticals.

Depending on its use, lindane is considered a pesticide or a drug. As a lice or scabies product intended to be used on the human body, it is registered with the Food and Drug Administration as a drug. When it is applied in other ways, it is typically registered with the Environmental Protection Agency as a pesticide.

EPA Slammed for Refusing to Allow CA to Regulate Vehicle Gas Emissions

Friday, December 21st, 2007

Freedom from Oil Campaign Slams EPA for Refusing to Allow California to Regulate Vehicle Greenhouse Gas Emissions

SAN FRANCISCO, CALIFORNIA - Rainforest Action Network Campaign Director Sarah Connolly and Global Exchange Campaign Director Nick Magel today released the following statement in response to the Environmental Protection Agency’s refusal to grant California a waiver allowing the state, rather than the federal government, to lead the way in regulating vehicle greenhouse gas emissions:

The EPA might as well change its name to the Automakers Protection Agency.

Let’s be clear: with this decision, the EPA is cowing to the influence of the auto industry rather than protecting the interests and health of the American people.

We have a short window of time to get greenhouse gas emissions under control. With forty percent of California’s greenhouse gas emissions coming from transportation fuels, establishing vehicle emissions standards is an obvious first step toward protecting the climate and the public health of all Americans.”

California’s AB 1493, also called the Pavley Law, seeks to establish vehicle greenhouse gas pollution standards. A lawsuit filed by the automakers to block implementation of the law was dismissed in federal court December 12.

Contact:
Rainforest Action Network (RAN)
Jenny Harbine, Earthjustice, (406) 586-9699

http://www.organicconsumers.org/articles/article_9224.cfm

Doctors Are Clueless About Medication for Kids

Thursday, December 20th, 2007

Information on how to prescribe medications to children is scarce, and doctors often rely on the flawed assumption that children are simply smaller versions of adults when doing so.

In reality, drugs act much differently in children, yet few studies have been conducted to determine their effectiveness, safety and proper dosages.

Federal regulators have enticed or forced pharmaceutical companies to conduct studies on more than 200 drugs geared for children, but more than two-thirds of the medications given to children remain untested. Among those that were tested, it was found that:

  • One-fifth of drugs that work in adults are ineffective in children
  • One-fifth of the drugs were being prescribed at the wrong dosage
  • One-third of the drugs caused unexpected side effects, some of which were potentially fatal


Other alarming factors discovered were that children process drugs more quickly than adults do, and because children are still developing, drugs could stunt physical growth or impair emotional and cognitive development.

Researchers have identified categories of drugs that they say should be a priority for testing. These include drugs to treat cancers, infections, asthma, high blood pressure and hyperactivity, among others.

Hurdles still remain, however. Drug companies are often reluctant to study pediatric drugs because they represent only a small fraction of the market. Further, the drugs must be evaluated in four separate age groups, which makes analyzing data more difficult.

Parents are also wary about letting their children participate in studies for fear that they will be used as guinea pigs.

They don’t want their child to be thought of as a guinea pig or a rat in a study. What I try to explain is that if they are receiving a medication that hasn’t been studied, then they are essentially participating in an experiment anyway,” said Robert M. Ward, director of the pediatric pharmacology program at the University of Utah.


Sources: Washington Post November 23, 2007

Dr. Mercola’s Comments:

Children have long been given “off-label” medications that have never been proven “safe” for their tiny, developing bodies. Some estimates say that as many as 90 percent of babies in neonatal intensive care units are prescribed such drugs, at the expense of three times more side effects.

It’s worth noting that the primary reason why drugmakers have not invested part of their multi-billion-dollar research and development budgets on pediatric drugs is because they represent too small a portion of the market share.

In other words, there is not enough money to be made.

But make no mistake.

Just because a drug has been studied for children does not make it safe. Even drugs that are meant for kids can have horrifying side effects like suicidal tendencies and blindness.

A classic example of the dangers surrounding medications for kids came just recently with children’s over-the-counter cold medicines. These drugs were over prescribed to well-intentioned parents looking to soothe their children, despite the fact that there was very little evidence that they worked. In fact, there was growing evidence that many of these drugs were fraught with side effects.

How Many Drugs Are Your Kids Taking?

The sad reality is that kids in the United States are being vastly overmedicated, both with drugs meant for them and those that have yet to be tested. Consider these sobering facts:

  • Kids may be prescribed addictive protein-pump inhibitors (PPIs) for heartburn. This is simply inexcusable. There is virtually never a medical justification to use these dangerous and untested for safety drugs in children. Avoid them at all costs.
  • Another ridiculous and absolutely unnecessary use of drugs is the American Heart Association’s recommendation for statin cholesterol-lowering drugs for kids.
  • More than three-quarters of surveyed U.S. pediatricians have recommended over-the-counter sleep aids to children, and more than 50 percent have prescribed a sleep aid.
  • Some 1.6 million children and teens take at least two psychiatric drugs, and close to 20 percent of them are under age 10.
  • Two out of three babies receive antibiotics by their first birthday.

Please realize that nearly all of the problems for which kids are given drugs can be resolved using natural methods. For example, one of the most commonly misunderstood reasons why parents rush their children to a doctor is because they have a fever.

Well, a fever is actually a good thing.

High fevers are especially good as they are far better than any immunization at building an authentic, life-long immune response. When you suppress these fevers with Tylenol or another medication, you can cause far more harm than good. (I advise avoiding most all of the anti-fever medications unless your child is absolutely miserable or the fever is over 104 degrees F.) A tepid bath can be a soothing and effective alternative also.

Behavioral problems can also be treated without drugs. Kids with ADHD, for instance, often improve greatly by taking these simple steps:

  • Eliminate grains and sugars from their diet
  • Replace soft drinks, fruit juices and pasteurized milk with pure water
  • Increase their omega-3 fats by giving them krill oil

I would strongly encourage you to do the research before giving your child any medication, and only do so if there is truly no other option (you may need to seek out the opinion of a doctor who is knowledgeable about natural medicine).

If you are still skeptical about the toxic effects drugs have on kids, I urge you to invest some time to watch The Drugging of Our Children, a documentary by Gary Null. It is a powerful testimony to the urgent need for change.

Source: www.mercola.com

HPV Vaccine Hoax Exposed

Wednesday, December 19th, 2007

FDA Documents Reveal HPV “Not Associated with Cervical Cancer”

A NewsTarget investigation has revealed that the FDA knew as early as 2003 that Human Papilloma Virus (HPV) was not linked to cervical cancer. Despite this knowledge, the FDA, along with key pharmaceutical companies, has continued to push for the use of HPV vaccinations as a defense against cervical cancer, even when its own research showed no link exists.

Today, NewsTarget publishes, “The Great HPV Vaccine Hoax Exposed,” a special report that cites from numerous FDA documents and clinical studies to show that HPV vaccines are not only ineffective, they may actually be dangerous! As revealed in the special report, the Gardasil vaccine has been linked to a 44.6% increase in precancerous lesions in some women, raising serious doubts over the sensibility of mandatory vaccination policies.

The special report is available now at:

http://www.newstarget.com/Report_HPV_Vaccine_0.html

This special report reveals:

  • The FDA stating “HPV is not associated with cervical cancer.”
  • Evidence that shows HPV vaccines actually increase the risk of precancerous lesions by 44.6% in some women.
  • The FDA admitting that “most [HPV] infections are short-lived and not associated with cervical cancer.”
  • Why mandatory vaccination policies ultimately lead to the harming of young women.
  • Why one shocking study published in JAMA (August, 2007) concluded, “No significant evidence of a vaccine therapeutic effect was observed…” and added, “… rates of viral clearance over a 12-month period are not influenced by vaccination.”
  • The real story behind the HPV vaccination frenzy: Disease mongering, corporate profits and junk science.

These revelations (and more) are spelled out in detail in this new special report by Mike Adams, the Health Ranger, a consumer health advocate and bioethicist who strongly opposes mandatory vaccination policies. The report is available now at no charge at:
 http://www.newstarget.com/Report_HPV_Vaccine_0.html

Mike Adams, the Health Ranger, has also posted a YouTube video introducing the key evidence in the HPV vaccination fraud. This video is available for viewing at:
 http://www.youtube.com/watch?v=XK97CHQZhq0

In addition, Adams discusses the HPV vaccination fraud in Dr. Steve’s Real Health podcast, episode #11, available at http://web.mac.com/drsteve720/Site/Podcast/Podcast.html

Source: http://www.newstarget.com/022404.html

Host a SICKO House Party and Get a Free Copy of the Film

Tuesday, December 18th, 2007

Five steps to a good time, and being involved all at once!

1. You throw a party at your house. It could be as few as 3 to 5 people - or more - it’s up to you.

2. Fill out the attached form and send it to the California Nurses Assn (CNA) by email or otherwise:

Vera George
Kaiser Division Secretary
California Nurses Association
National Nurses Organizing Committee
2000 Franklin Street, Oakland, CA 94612
Tel: 510-273-2210 Fax: 510-663-1681
 VGeorge@calnurses.org

3. CNA sends you a SICKO House Party Kit. The Kit includes a free DVD of Michael Moore’s latest documentary “SICKO” for you to keep!

4. You show the movie, have a good time with friends, and do something to get the profit out of healthcare in Amerika.

5. Have fun & learn about the healthcare crisis in this country and how Single Payer can work.

http://www.healthcare-now.org/

Source: http://www.organicconsumers.org/articles/article_9134.cfm

Is Your Toothpaste Really “Natural”?

Monday, December 17th, 2007

As a natural lifestyle continues to appeal to greater numbers of people, many are extending their desire for natural products to toothpaste. There are now a wide variety available, with or without fluoride, and in many flavors and forms.

However the definition of “natural” is not regulated, particularly if the toothpaste is non-fluoride. Fluoride toothpastes are considered a drug by the U.S. Food and Drug Administration (FDA) and are therefore regulated. Non-fluoride toothpastes, however, are considered cosmetics and it’s “up to the manufacturers to be careful with their labeling,” according to the FDA.

Meanwhile, natural means that a product is free from artificial colors, flavors and preservatives. It may still contain highly processed ingredients, such as fluorides, abrasives and humectants.

One brand of natural toothpaste, Tom’s of Maine, was purchased by Colgate-Palmolive last year and became the first natural toothpaste to receive the Seal of Acceptance from the American Dental Association (ADA).

The seal does not necessarily mean that the ADA endorses a product, only that it is effective and does what it says it will do, the ADA pointed out.

In short, it remains a “buyer beware” environment for natural products, including toothpastes. But there are now more toothpaste options available than ever, which allows each person to make their own choice.
Sources: The Colorado Springs Gazette November 24, 2007

Dr. Mercola’s Comments:

Typical toothpaste is regulated as a drug by the FDA because an average tube contains enough fluoride to kill a small child. Most people in the United States have been living under the false assumption that fluoride toothpaste is essential to preventing cavities, when in reality it is a dangerous poison.

Too much fluoride can lead to fluorosis, a discoloring of your teeth and breakdown of enamel — itself a result diametrically opposed to the dental health it supposedly is meant to prevent — and more serious developmental problems such as lower IQ. Excessive use of fluoride also increases your risk of osteoporosis and can damage your nervous system, not to mention its links to:

  • Cancer
  • Developmental and reproductive toxicity
  • Endocrine disruption
  • Organ system toxicity
  • Neurotoxicity

As the word about the dangers of fluoride gets out — even the American Dental Association admitted this year that fluoride is bad — more of you are seeking out natural toothpaste varieties.

Others are seeking natural toothpastes because they’re catching on to the importance of limiting your exposure to as many artificial chemicals as possible. And rest assured that fluoride is not the only skeleton hiding in your typical toothpaste’s closet.

A quick reading of the ingredients in one leading brand of toothpaste reveals:

  • Triclosan: A preservative and cosmetic biocide that has been linked to endocrine disruption, organ system toxicity, and bioaccumulation
  • Sodium lauryl sulfate: A cleansing agent linked to cancer and developmental and reproductive toxicity
  • Tetrasodium pyrophosphate: An oral care agent that animal studies have found impact your brain and nervous system at low doses
  • Hydrated silica: An anticaking agent that bioaccumulates in people and wildlife
  • FD&C Blue 1: An artificial coloring linked to cancer

You would think, then, that a natural toothpaste label would be much more, well, natural. Some, in fact, are. But you must be careful to read the label and know what you’re buying. For instance, here are some of the ingredients in a leading non-fluoride natural toothpaste:

  • Sodium monofluorophosphate: An oral care agent linked to neurotoxicity, developmental and reproductive toxicity, and possibly cancer.
  • Sodium lauryl sulfate: Same as above.

The bottom line is that personal care products are not regulated, and those that claim to be natural can be far from it.

Look for a simple natural, non-fluoride toothpaste with only familiar ingredients, and skip all of the bells and whistles like “whitening,” “enamel strengthening,” and “multi-action.” If you’re looking for a safe way to make your teeth whiter, you can try this truly natural formula using strawberries and baking soda.

www.mercola.com

Action Alert – Stop Monsanto’s Attempt to Force Bovine Growth Hormone on Consumers

Sunday, December 16th, 2007

The messages we’ve sent and phone calls we’ve made to Pennsylvania’s governor Ed Rendell have had a significant effect in putting a temporary hold on Pennsylvania’s proposed ban on all types of rBGH-free labeling. There are serious negotiations going on now and we should have some major news before Christmas. THANK YOU for taking action - it’s having an effect!

Ohio also has a committee looking at this issue and may consider a labeling ban like Pennsylvania’s. Their committee is more balanced than PA’s (it has at least three people opposed to rBGH) but get this: There is only one person out of 20 on the committee listed as a consumer, even though labeling is primarily a consumer issue. This “consumer” was, until recently, a Monsanto field representative in Ohio that sold rBGH. Moreover, nearly all the dairy farmers on the committee use rBGH, even though a large majority of farmers throughout the nation don’t use it.

The antidote to the poison of undue corporate influence is massive public response - PLEASE send a message to Ohio’s governor, Ted Strickland, to let him know that the nation is watching them too. And please act soon, since Ohio is moving very quickly and may make a decision by the end of this year. THANK YOU!

And please do this again: FORWARD THIS TO ANYONE YOU KNOW AND ASK THEM TO ALSO SEND A MESSAGE. Our rights as consumers and citizens are being threatened again - we must stand up to Monsanto and their bedfellows.

______________________________________________________________
The contact information is:
To send an e-mail, go to the governor’s website: http://governor2.ohio.gov/.
Then click on “Contact us” on the right hand side and you can send your e-mail. To telephone the governor’s office call: 614-466-3555

To mail a letter, use this address:
Governor Ted Strickland
Governor’s Office
Riffe Center, 30th Floor
77 South High Street
Columbus, OH 43215-6108

www.organicconsumers.org

Study Reveals 17 Different Pharmaceuticals In Wastewater

Saturday, December 15th, 2007

What happens to medicines after they leave your body? Norwegian researchers have examined the presence of twenty toxic pharmaceuticals in the wastewater coming from two Oslo hospitals. Their stunning conclusion is that seventeen of these toxins were actually present in the wastewater! When they examined the wastewater flowing into the water treatment works (WTWs), they again found twelve pharmaceuticals.

Ok, so there are chemical compounds in our wastewater you might say, that’s why it’s waste. Wrong. Although there are a lot of wastewater treatment works (WTWs) on our planet, a considerable amount of wastewater still flows back into nature. In this case, the pharmaceutically polluted water flows into the Oslo fjord environment. Furthermore, when they examined the purified water coming from the WTWs, the researchers were still able to detect eleven pharmaceuticals in the ‘clean’ water. This is cause for concern about the environment, people, and animals living in these fjords. This scientific study was commissioned by the The Norwegian Pollution Control Authority (SFT). The SFT wanted to study the presence of 20 pharmaceuticals in the wastewater during a twelve week period.

Pharmaceutical drugs are polluting our water

When Norwegian researchers examined the wastewater coming from two hospitals (Rikshopitalet and Ulleväl) they were able to detect all of the 20 studied substances, with the exception of three. Then they examined the water just before it entered the purification plant. At this point in the chain, the chemicals were already diluted. Still, the researchers were able to find twelve different substances above detection level. The third phase in this scientific study focused on the quality of purified water. When they checked the water flowing out of the water treatment works, there were still eleven pharmaceutical substances present.

The substances that were present in the highest concentration throughout this research study were paracetamol, iboprufen, diclofenac and metoprolol. After purification, these substances were still detectable in the water (along with seven others). This means that the WTWs are not able to filter out pharmaceutical drugs, on the contrary, they might even be responsible for toxic by-products left in the purified water:

Scientists around the world often find drugs in water samples taken from streams and other waterways, but little is known about by-products of those drugs created during chlorine treatment or time spent in the environment,” said the researchers, headed by NIST chemist Mary Bedner.

In an earlier study done in 2004, researchers from the US National Institute of Standards and Technology (NIST) examined what happens to chemical pharmaceuticals when they react with chlorine - a disinfectant commonly used in wastewater treatment. One of their conclusions was that paracetamol, which is highly present even in purified water, forms multiple byproducts when combined with chlorine, two of which are highly toxic. When pharmaceutical drugs react with chlorine, they mostly form hydrophobic compounds, which tend to build up in the body. This study agrees with the Norwegian study, that water treatment works cannot fully purify water.

What can we do about it?

There are still large areas that are not covered by water purification plants throughout the globe. In our chemical age, we almost forget that maybe our dishwasher water (or medicated urine) flows into a nearby brook. And even if our waste goes to WTWs, it is not guaranteed that it will be totally detoxified.

Preventing is better than curing

Use natural products whenever you can. Try to avoid buying any products from drug companies. There are lots of natural alternatives available. You can even build a pharmaceutical factory in your back yard and grow your medicine for free!

If everyone starts taking responsibility and stops listening to the drug companies, we might be able to turn the results of the next SFT study drastically around. Saving the earth begins by saving ourselves!

About the author
Dorien Herremans is a commercial engineer (MSc University of Antwerp) and is currently a lecturer at Gesthotel University. She is the founder of raw-vegan.org, a living food network in Europe and runs a raw vegan Bed and Breakfast and retreat center in a 100% natural loghome in the Swiss Alps. For more information about the center or staying in Naturalp, please visite naturalp.org

Source: www.newstarget.com

Nation’s Largest Retailers Accused of Organic Fraud

Friday, December 14th, 2007

Milk

Class Action Suits Seek Damages from Wal-Mart, Target, others.

In a scandal now ensnaring some of the nations leading retailers, a series of lawsuits have been filed accusing Wal-Mart, Costco, Target, Safeway, and Wild Oats of consumer fraud for marketing suspect organic milk.

The legal filings in federal courts in Seattle, Denver, and in Minneapolis, against the retailers, come on the heels of class action lawsuits against Aurora Dairy Corporation, based in Boulder, Colorado. The suits against Aurora and the grocery chains allege consumer fraud, negligence, and unjust enrichment concerning the sale of organic milk. This past April, Aurora officials received a notice from the USDA detailing multiple and “willful” violations of federal organic law that were found by federal investigators.

“This is the largest scandal in the history of the organic industry,” said Mark Kastel of The Cornucopia Institute, a Wisconsin-based farm policy research group. Cornucopia’s own investigation and formal legal complaint, in 2005, first alerted USDA investigators to the improprieties occurring at Aurora. “Aurora was taking advantage of the consumer’s good will in the marketplace toward organics, and the USDA has allowed this scofflaw-corporation to continue to operate,” Kastel added.

Law firms based in Seattle, St. Louis, and New York, in addition to other cities, have filed at least eight lawsuits against Aurora, representing plaintiffs in over 30 states. Five lawsuits against the retailers have been filed so far.

Attorneys are seeking damages to reimburse consumers harmed by the company’s actions. Some of the lawsuits request that the U.S. District Courts put an injunction in place to halt the ongoing sale of Aurora’s organic milk in the nation’s grocery stores until it can be demonstrated that the company is complying with federal organic regulations.

Aurora, with $100 million in annual sales, provides milk that is sold as organic and packaged as private label, store-brand products for many of the nation’s biggest chains. In addition to Wal-Mart, Target, Costco, Safeway, and Wild Oats, Aurora serves as supplier to 15 other national and regional chains.

Independent investigators at the USDA concluded earlier this year that Aurora—with five dairy facilities in Colorado and Texas, each milking thousands of cows—had 14 “willful” violations of federal organic regulations. One of the most egregious of the findings was that from December 5, 2003, to April 16, 2007, the Aurora Dairy “labeled and represented milk as organically produced, when such milk was not produced and handled in accordance with the National Organic Program regulations.”

Cornucopia’s own research, since confirmed by the two-year investigation by federal law enforcement agents, found that Aurora was confining their cows to pens and sheds in feedlots rather than grazing the animals as the federal law requires. Furthermore, Aurora brought conventional animals into their organic milking operation in a manner prohibited by the Organic Food Production Act, a law passed by Congress in 1990 and implemented in 2002 by the USDA.

The stores sell Aurora’s milk under their own in-house brand names, such as Costco’s Kirkland and Target’s Archer Farms, in cartons marked “USDA organic,” typically with pictures of pastures or other bucolic scenes.

That’s not even close to the reality of where this milk was coming from,” said Steve Berman, a Seattle lawyer whose firm is among those suing. “These cows are all penned in factory-confinement conditions.”

“This is the perfect example of modern-day Agri-business bullies literally stealing the milk money from an unsuspecting public,” said Washington state consumer Rachael Doyle. “We have been willfully deceived by corporations motivated solely by greed.”

Cornucopia points out that Aurora is a “horrible aberration,” and that the vast majority of all organic dairy products are produced with high integrity. In a scorecard published last year, and available on their web site, Cornucopia rates over 90% of organic name-brand dairy products as truly subscribing to the letter and spirit of the law (available at www.cornucopia.org).

“Aurora’s actions have injured the reputation of the more than 1500 legitimate organic dairy farmers who are faithfully following federal organic rules and regulations,” noted Kastel. “We cannot allow these families to be placed at a competitive disadvantage.”

Mark Pepperzak, Aurora CEO, said, “The allegations in this smear campaign against AOD are based on false information and, therefore, completely unfounded.” The company has said that their business has yet to be affected by the high-profile controversy. However, some of Aurora’s largest customers have now switched to alternative suppliers.

We have learned that Wild Oats and the Publix supermarket chain in Florida are no longer buying milk from Aurora,” stated Kastel. “In addition, the nation’s largest distributor of natural and organic products, United Natural Foods, Inc. (UNFI) has also secured an alternative source for their Woodstock Farms brand.” Kastel also said that although he was unable to publicly disclose the names of retailers at this point in time, a number of others have contacted Cornucopia for their listing of six other private-label organic milk processors.

Many industry observers feel that the USDA’s enforcement mechanism broke down in the Aurora case. After career USDA staff drafted a Letter of Proposed Revocation, seeking to prevent Aurora from engaging in organic commerce, political appointees at the agency intervened, crafting an agreement allowing the politically connected company to remain in business.

It is unconscionable that the USDA allowed Aurora to continue, after making millions of dollars, in this ‘ethics-based’ industry, when they had concluded that Aurora willfully violated the law,” Kastel added. “However, there is a higher authority in terms of organic integrity than the USDA—that’s the organic consumer. And they are about to make their voices heard through the courts.”

www.cornucopia.org

Cholesterol-Lowering Drugs: What Are Drugmakers Hiding?

Thursday, December 13th, 2007

Nearly two years after a clinical trial of the cholesterol-lowering drugs Zetia and Vytorin was finished, the results have still not been released by the drugs’ makers (Merck and Schering-Plough).

Yet, close to 800,000 prescriptions for the drugs are written each week in the United States, bringing in close to $4 billion for the year.

The companies have responded to cardiologists’ concerns over the lack of safety data for the drugs by promising to publish only a portion of the results in March, a move that critics are calling highly unusual.

Currently, no one knows whether Zetia and Vytorin are as effective as other cholesterol-lowering medications called statins. If they turn out to be less so, patients may be unnecessarily at risk of heart attacks.

Zetia was approved by the U.S. Food and Drug Administration in 2002 because it was found to lower LDL cholesterol by 15 to 20 percent. Vytorin combines Zetia with Merck’s statin drug, Zocor.

Together, the drugs have acquired close to 20 percent of the U.S. market for cholesterol-lowering drugs.

However, because Zetia and Vytorin work differently than standard statin drugs, cardiologists have expressed concerns that they may not protect the cardiovascular system as much as using a statin does.

Drugmakers Changed the Trial’s Endpoint

Along with announcing that they will only be releasing part of the clinical trial’s results, Merck and Schering-Plough said they had changed the trial’s endpoint, or the final result the study was supposed to measure.

Typically, the trial’s endpoint is supposed to remain constant because otherwise the study’s authors could change their goals to conform to the data they received.

The delay in publishing the study’s results raise further questions as to whether the drug industry is improving their disclosure of clinical trials.

Two years ago drugmakers promised to disclose study results publicly, however they face few penalties for failing to do so.


New York Times November 21, 2007

Dr. Mercola’s Comments:

It is a common trick of the drug cartel to overwhelmingly make public only the positive results to their clinical trials. And if it doesn’t look like you’re going to get any positives, well then you just change what you were looking for (which could easily be the purpose behind Merck and Schering-Plough’s decision to change their trials endpoint).

But the thing that gets me the most riled up is the blatant fact that millions of Americans have been taking these drugs, and paying for the privilege, without any solid evidence whether they’re truly effective (let alone what the real risks are).

The cardiologists referred to in the New York Times article are right to express concern over prescribing drugs that may or may not work. But they missed the boat in comparing these newer cholesterol-lowering drugs to their “gold standard,” the statins. In reality, neither drug is the answer.

PLEASE Understand — Drugs are Not Your Answer to High Cholesterol

It may surprise you to learn that cholesterol is not the major culprit in heart disease or any disease. It may surprise you even more to learn that the guidelines that dictate what number your cholesterol levels should be to keep you “healthy” are fraught with conflict of interest — and have never been proven to be good for you.

It is VERY rare for anyone to need cholesterol-lowering drugs. Among the more than 20,000 patients who have come to my clinic, only four or five of them truly needed these drugs, as they had genetic challenges that required it. If you or someone you know is taking them, odds are very high, greater than 100 to 1, that you or they don’t need it.

This is true whether the drugs are statins or the newer Zetia and Vytorin.

You should know that among the many dangers of statins drugs is an increased risk of heart disease. This is because patients taking statins become depleted in Coenzyme Q10 (CoQ10), which leads to fatigue, muscle weakness, soreness and, ironically, heart failure.

The FDA has had a petition to label statin packages with a warning about statin-induced CoQ10 depletion for years, but nothing has been done about it. Some of the other risks of statin drugs include:

  • Weakness
  • Muscle aches
  • An increase in cancer risk
  • Immune system suppression
  • Serious degenerative muscle tissue condition (rhabdomyolysis)
  • Potential increase in liver enzymes so patients must be monitored for normal liver function

What can you do to protect your heart and keep your cholesterol levels where they naturally should be, without exposing yourself to these outlandish risks?

  • Reduce, with the plan of eliminating, grains and sugars in your daily diet.
  • Eat the right foods for your nutritional type.
  • Get the right amount of exercise.

For the vast majority of people, it really is as simple as that.

www.mercola.com