Friday, June 30, 2006

MERCK'S GARDASIL VACCINE NOT PROVEN SAFE FOR LITTLE GIRLS

..."This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls."
Merck says that this vaccine, at $360 a series, will not have data on vaccination of little boys until 2008. Of course adding to the already heavy overlay of harmful vaccines will do little but raise money for Merck in the meantime. The Feds are also boosting profits by tying the expense into the national program for recommended vaccines.

And don't fail to overlook the glamourous capaign of stars and starlets travelling around the country to help you make a bracelet through for an alleged educational organization funded by Merck - www.maketheconnection.org/

A more insidious drug company strategy involves directly influencing so-called consumer organizations. A report in 2003 warned:
"Pharmaceutical companies are pouring millions of dollars into patient advocacy groups and medical organisations to help expand markets for their products. Many groups have become largely or totally reliant on pharmaceutical industry money, prompting concerns they are open to pressure from companies pushing their products.15"

The influence of pharmaceutical companies over consumer groups is a big concern, according to Martyn Goddard, the health policy officer with the Australian Consumers' Association. "Drug companies find it very easy to recruit consumer groups and they do it very cheaply," he said. "There's almost no such thing as clean money for most consumer organisations.15" With this money comes drug company influence on what these organizations say and the treatments they recommend." from Jay S. Cohen, MD


I think it would be great if Merck would fund CHI so it can do education from the point of view that there is a requirement to provide all the risks and actual benefits of any drug or vaccine. Maybe 'Make the Connection' will share some of their bounty with us as well. CHI helps people learn to make those forgotten informed decision that make taking a drug or vaccine legal. Always question the 'authorities' about forced questionable pharmaceuticals for your best health.

"Informed consent can be effectively exercised only if the patient possesses enough information to enable an intelligent choice (AMA, 1999)."

---------------------------------------------------------

National Vaccine Information Center Criticizes FDA for Fast Tracking Licensure

Washington, D.C. - The National Vaccine Information Center (NVIC) is calling on the CDC's Advisory Committee on Immunization Practices (ACIP) to just say "no" on June 29 to recommending "universal use" of Merck's Gardasil vaccine in all pre-adolescent girls. NVIC maintains that Merck's clinical trials did not prove the human papillomavirus (HPV) vaccine designed to prevent cervical cancer and genital warts is safe to give to young girls.

"Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials," said NVIC president Barbara Loe Fisher. "Merck's pre and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed. This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls.


The FDA allowed Merck to use a potentially reactive aluminum containing placebo as a control for most trial participants, rather than a non-reactive saline solution placebo.[1] A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial. Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials. Merck and the FDA did not disclose how much aluminum was in the placebo.[2]

Animal and human studies have shown that aluminum can cause nerve cell death [3] and that vaccine aluminum adjuvants can allow aluminum to enter the brain, [4 5] as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue. [6 7] Nearly 90 percent of Gardasil recipients and 85 percent of aluminum placebo recipients followed-up for safety reported one or more adverse events within 15 days of vaccination, particularly at the injection site.[8] Pain and swelling at injection site occurred in approximately 83 percent of Gardasil and 73 percent of aluminum placebo recipients. About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. [9 10] Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.

"Merck and the FDA do not reveal in public documents exactly how many 9 to 15 year old girls were in the clinical trials, how many of them received hepatitis B vaccine and Gardasil simultaneously, and how many of them had serious adverse events after being injected with Gardasil or the aluminum placebo. For example, if there were less than 1,000 little girls actually injected with three doses of Gardasil, it is important to know how many had serious adverse events and how long they were followed for chronic health problems, such as juvenile arthritis."

According to the Merck product manufacturer insert, there was 1 case of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis, and 1 case of reactive arthritis out of 11,813 Gardasil recipients plus 1 case of lupus and 2 cases of arthritis out of 9,701 participants primarily receiving an aluminum containing placebo. Clinical trial investigators dismissed most of the 102 Gardasil and placebo associated serious adverse events, including 17 deaths, that occurred in the clinical trials as unrelated.

"There is too little long term safety and efficacy data, especially in young girls, and too little labeling information on contraindications for the CDC to recommend Gardasil for universal use, which is a signal for states to mandate it," said Fisher. "Nobody at Merck, the CDC or FDA know if the injection of Gardasil into all pre-teen girls - especially simultaneously with hepatitis B vaccine - will make some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults. With cervical cancer causing about one percent of all cancer deaths in American women due to routine pap screening, it was inappropriate for the FDA to fast track Gardasil. It is way too early to direct all young girls to get three doses of a vaccine that has not been proven safe or effective in their age group."

The National Vaccine Information Center (NVIC), founded in 1982 by parents of vaccine injured children, has been a leading critic of one-size-fits-all mass vaccination policies and the lack of basic science research into biological mechanisms and high risk factors for vaccine-induced brain and immune system dysfunction. As a member of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC), Barbara Loe Fisher urged trials include adequate safety data on pre-adolescent children and warned against fast tracking Gardasil at the November 28-29, 2001 VRBPAC meeting .[11]

Full 2001 FDA Transcript: http://www.fda.gov/ohrms/dockets/ac/cber01.htm#Vaccines & Related Biological

For more information go to www.NVIC.org.

Sunday, June 18, 2006

Food Police in action on false facts

Standing Up To Big Pharma, Big Food, Big Medicine and Big Government

Dr. Eric Topol, a Cleveland cardiologist, one of the earliest critics of Vioxx, has learned the hard way that being outspoken and having integrity can carry a heavy price when speaking out.

In 2004, Dr. Topol published a paper in the Journal of the American Medical Association that first raised concerns that Vioxx, a painkiller, could cause cardiovascular problems.

During one of the class action lawsuits against Merck, the maker of Vioxx, Dr. Topol was called to testify. He reportedly accused Merck of scientific misconduct by misrepresenting its own laboratory findings about the drug's safety.

Less than a week after this testimony, Dr. Topol was fired as chief academic official of a medical college in Cleveland. The reason given by college officials was 'administrative reorganization.'

Dr. Topol was quoted in a newspaper report as saying his firing was a direct consequence of his outspokenness. "The hardest thing in the world is just trying to tell the truth, to do the right thing for patients, and you get vilified. No wonder nobody stands up to the (drug et al) industry."

Now we have the AMA, quoting on their web site that it is the organization that is helping doctors help patients.

The AMA is calling for measures to reduce sodium intake in U.S. diet and urges the FDA to revoke "generally recognized as safe" status for salt in an effort to reduce the burden of cardiovascular disease.
"Cardiovascular disease remains the number one killer of Americans. People who reduce dietary sodium intake are taking an important step in preventing future health problems," said AMA Board Member and practicing cardiologist J. James Rohack, MD. "We hope these recommendations will encourage food manufacturers and restaurants to modify their current practices of adding unhealthy amounts of sodium to their products."

The standard pitch for decades has been that excess sodium greatly increases the chance of developing hypertension, heart disease, and stroke. Research shows most Americans consume two to three times the amount of sodium that is healthy, with an estimated 75 to 80 percent of the daily intake of sodium coming from processed and restaurant foods.

"Just one cup of canned soup can contain more than 50 percent of the FDA recommended daily allowance," explains Dr. Rohack. "A serving of lasagna in a restaurant can put a diner over their recommended daily sodium allowance in just one meal. These examples stress the importance of a national reduction in the amount of sodium in processed and restaurant foods."

The recommendations adopted today include:

* urging the Food and Drug Administration (FDA) to revoke the "generally recognized as safe" (GRAS) status of salt and to develop regulatory measures to limit sodium in processed and restaurant foods;
* calling for a minimum 50 percent reduction in the amount of sodium in processed foods, fast food products and restaurant meals to be achieved over the next decade;
* working with appropriate partners to educate consumers about the benefits of long-term, moderate reductions in sodium intake;
* discussing with the FDA ways to improve labeling to assist consumers in understanding the amount of sodium contained in processed food products and to develop label markings and warnings for foods high in sodium.

The AMA is confident the implementation of these recommendations would reduce sodium intake, result in a better educated consumer, and eventually lower the incidence of hypertension and cardiovascular disease in this country.

Now if you try to go to the core of this issue you find some very interesting things. *Some studies show it might be 'chloride' that is the culprit.
*Some studies show that it is the processing of salt, when heated to 1400 degrees F that drives out impurities, minerals, and any water in the compound that makes 'salt' the problem.

The AMA and obviously the FDA and perhaps the USDA have not looked at the food industry to take a more active role in addressing all the 'salt' in food and other consumer products. Then we have the upcoming artificial salt flavoring approved for consumption by humans without any labeling requirements. No one has look at soda. The AMA recently tabled the issue to limit the intake of soft drinks, so perhaps the pressure is on the medical mafia to ignore this source of dietary sodium.

You know you gotta start reading the labels.

And, just maybe the AMA oughta start paying more attention to the work of one of their own, Dr. John Laragh, who believes that salt is a critical factor in health.

It is true that pigs often eat their young. You might ask why, and when you do you find that the answer lies in having too little salt. You also might ask about al those salt licks used for animal health. Then you could ask just why animal studies are looked at so akin to humans. And I suppose the string could go on for more than a few miles on this one.

So where do I think this should go?

Just maybe to the use of natural salt*, you know, the funny looking stuff that is often in color but no matter the form, still is replete with precious minerals not burned out by processing.

This is just another call from me to say "Hey!" "How about reading some labels..."

It might just be that easy.

*natural salt information is readily available from the Leaflady

and look for her acclaimed book - The Road to Health Natural Care Series: Blood Pressure Care Naturally

Saturday, June 10, 2006

One More Time, with feeling

As they see it, at the CDC, about 500 people each year die in the US from flesh-eating bacteria. This comes as a comment following the death of a young University of Tulsa football player. To me, it seems as if they think this is par for the course. Since these 'experts' tell us that antibiotics no longer are effective, are they throwing their hands in the air, with hopelessness?

I suppose this hopelessness is that no one yet has figured out that there just might be some effective treatment if they by-passed the money-engine that otherwise refer to as a pharmaceutical company.

As an idealist, with a clear understanding that money, drugs and insurance drive the health care industry today, I still hold out hope for something better.

To borrow from one of my favorite book titles, "small is beautiful: 'medicine', as if people mattered".

Well, serendipity crossed my computer a few weeks ago when I received an abstract about a real medical doctor at Georgetown that had done some research involving the use of essential oils and their antibiotic effect.

I started out on this quest about 1996 when difficult bacterial infections like E.coli and flesh-eating bacteria first hit the print pages.

The way I looked at this, people were suffering and dying when they did not have to.

I started writing letters, hoping for a reply with a show of some interest (silly me). The first was to the Washington state health department director, who never answered my letter.

I continued to monitor the cases reported in the news, growing world-wide as time passed. I would write the doctors named in articles, reporters writing articles; about any one I thought might take interest in saving life.

About two years ago I finally issued my 'Challenge to Mainstream Medicine to Think Outside the Box". This was posted in an international publication on the web, and of course I was hoping for replies. I issued it again in 2005 and 2006, yet only one health professional, a dentist from New Zealand, cared to reply.

Dr. James Howenstine ran an article or two. He was very gracious in his reply, yet underscored that the money issue was the obstacle.

Then, low and behold, the oregano oil research article from dear Dr. Harry Preuss at Georgetown ended up in my e-mail.

This was just after I responded with an essential oil and herbal remedy for someone in Canada who was suffering with amoebic dysentery and a nasty little bug called Blastocystis.

I contacted Dr. Preuss and shared my thoughts with him. He welcomed my contact and kindly sent me copies of his research.

While he continues to search for funding to do more research, he correctly advises me that traditional medicine is "just not ready for this.

Yes, we can just put more millions into 'research' for some new patented anti-biotic that might end up killing people or causing diabetes, even though approved by the FDA.

We can do this, or we can start to care about people's lives and first do not harm.

Like a grateful person told me about one of my essential oil treatments - see comments

Medical students in France receive education in the use of botanical medicine and essential oils.

If they can do it in France, with more effective health care than the states, they can - and should - do it here.

Or if interested, they can sign up for my course, or inquire about my protocols.

--------------------------------------

Related article -
Super Bug: Merck pursues soil bacteria in research. Patent anyone?

It's the Worms

When my youngest child was little she ate things like handfuls of sand on the beach at the shore and budding tulip flower heads in her grandmother's yard. She made mudpies because I relished that thought from childhood days when I was dressed in hand-smocked percale dresses with bow-tie sashes in the back, being admonished if I were to get dirty before going off to Sunday dinner in the Ladie's Dining Room at the Union League or the country club.

We used antibiotics only when really necessary and our pediatrician was also wise enough to help us avoid unnecessary vaccinations. My children also had the real thing like chicken pox and measles, just like I did.

Yes, we were taught that having these normal childhood dis-eases helped the immune system fulfill its purpose.

Now what do we hear? Maybe the cause of some of the dis-eases plaguing industrialized countries is obsessive-compulsive hygiene.

And so what's new in medical research? Not leeches this year, just worm eggs, and a swig or two of Gatorade (no longer that electrolyte replacement drink you knew it for years ago, but one now heavy on the high fructose corn syrup - oh, isn't that the stuff that promotes diabetes?).

I am certainly not one to deny that intestinal dis-eases are not debilitating, but I do have to question the tunnel vision of medical researchers today for some of their outlandish ideas when they fail to look effective treatments for such conditions as Chrohn's dis-ease, or the new one that came out just after Novartis developed a drug for it (along with a very distasteful ad that is demeaning to women), IBS or 'irritable bowel syndrome'.

Well, with many recovered cases of these conditions in my files, I wonder why I didn't think of worm eggs, especailly after some really good, and time-tested natural treatments worked every time...

So now hear you go, read it for yourself and if you'd like something more reasonable if you are frustrated by this health concern, let me know.

Worms may help bowel disease

The upside of Linda Mansfield's research is that it may lead to a new treatment for inflammatory bowel disease. The downside is that it would involve swallowing worm eggs. Mansfield is a professor of microbiology at Michigan State University who specializes in the study of parasites.

She's also one of several researchers around the country looking at the use of threadlike intestinal parasites called whipworms to treat the disease, which can cause diarrhea, painful cramps and even intestinal bleeding.

"It's extremely debilitating," Mansfield told the Lansing State Journal for a story Friday. "People talk about having 256 bouts of diarrhea a year when they have this disease. It gets to the level where some of them are not able to work."

Inflammatory bowel disease, the most common forms of which are Crohn's disease and ulcerative colitis, is a condition that is virtually unknown in the developing world. But it is becoming increasingly common in industrialized countries.

Researchers have put forward several explanations for that, among them diets high in fat and refined foods. But another possible cause, Mansfield said, is increasing levels of hygiene.

Portions of the immune system actually require periodic infections in order to develop properly. Some exposure to dirt, bacteria and even worms can be beneficial.

"By living in an ultra-clean environment," Mansfield said, "we're removing some of the things that helped to educate our immune system."

Mansfield said it's possible that the human immune system developed in a way that's reliant, to some degree, on the presence of parasitic worms.

She wasn't the first to hit on that idea. A research team at the University of Iowa already has tried treating human patients with a whipworm egg and Gatorade cocktail. Their results were promising.

David Elliott was a member of that team.

"There are probably individuals in the population who, back when worms were prevalent, were the healthiest because their immune systems could fight off all sorts of things," he said. "When worms are removed, their immune systems become unbridled, and they move on to develop disease."

Mansfield came to the topic from an animal angle.

More than a decade ago, she began studying whipworm infections in pigs, initially trying to develop a vaccine against the parasites.

But one of the things she noticed along the way was that whipworm infections produced a strong anti-inflammatory immune response.

When given to patients with inflammatory bowel disease, the worms can help to counteract the inflammation and "actually reset the immune system to be in better balance," Mansfield said.

Further, pig whipworms are relatively safe. Most people will expel them in a matter of weeks and, if that doesn't happen, they can be eliminated with anti-worm drugs.

That's promising, if a little unpleasant, for people like Linda Rockey.

The Mason woman has suffered from Crohn's disease for more than 30 years. Having tried most conventional treatments, she said she's "right at the end of the rope."

If she had no other alternatives, she said, "if they said. `This is it. You eat these worms,' I would do it. At some point, you're willing to try anything."

The whipworm treatment still needs to undergo further testing before it can be approved by the FDA.

From: Lansing State Journal

Monday, June 5, 2006

Another healthy drug for women: Osteoporosis from breast cancer treatment

more than just osteoporosis -

Further down in this post you will find this paragraph:"Oncologist Julie Gralow, M.D., of the University of Washington and Fred Hutchinson Cancer Center in Seattle said that women should also consider other ways to improve bone strength, "such as exercise and use of bisphosphonates."

So what's this about 'bisphosphonates'?
While Fosamax is a fluoride based drug I ad vise against on the basis that is makes bones hard and brittle, not strong and flexible, while supporessing your thyroid, it just so happens that drugs like Actonel -from Proctor & Gamble pharmaceuticals- are made from by-products of TIDE, other wise known as bisphosphonates.

These drugs can lead to what is called ONJ or osteonecrosis of the jaw. Some call this "bone death" as a literal translation from the Latin might define. What it might mean to you is disfigurement, pain and mouth ulceration. Cancer patients seem to be more at risk receiving the drugs intravenously, as they may have to undergo much more invasive dental procedures.

Well, it just goes to show you that women are still on the second class list when it comes to health care.

It's not enough that mammography promotes cancer or chemotherapy leads to all kinds of health problems. Radiation can cause things like lung cancer and congestive heart failure, not to mention thyroid problems, or the 'Race for the Cure' does nothing to prevent or find the cure.

But now we have a breast cancer drug that gives you osteoporosis.

Just another action point on my 'Think Before You Pink' list.

***
Five Years of Arimidex Causes Bone Loss
By Peggy Peck, Managing Editor, MedPage Today
Reviewed by Robert Jasmer, MD; Assistant Professor of Medicine, University of California, San Francisco
June 04, 2006

Action Points
*Explain to interested patients that this report suggests that women taking Arimidex can have a significant loss of bone mineral density.

*This study was published as an abstract and presented in a poster at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.

Review
J. Leonard Lichtenfeld, M.D.
Amer. Cancer Society

ATLANTA, June 3 —

For women with normal bone density at baseline, however, five years of Arimidex is unlikely to cause osteoporosis, said investigators with the Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial, who reported the findings today at the American Society of Clinical Oncology meeting here.

Women taking Arimidex had about a 40% increase in risk of fractures while on the study, said Robert E. Coleman, M.D., Weston Park Hospital in Sheffield, England. "When the drug was discontinued the excess fracture risk declined," he added.

The overall fracture rate was 7.7% among women taking tamoxifen in the study versus 11% for women taking Arimidex. Dr. Coleman said the difference was significant, but did not report the P value. There was, he said, no statistically significant difference in the rate of hip fractures between women taking Arimidex and those taking tamoxifen.

The rate of bone mineral density loss decelerates over time so that the rate at two to five years was significantly less than the loss over the first two years of treatment, (mean difference in annual rate of change 0.0113, 95% CI 0.006-0.0017; P=0.0002).

Five patients with osteopenia at baseline developed osteoporosis by five years, he said.

After five years, women taking Arimidex lost 6.1% of bone mineral density at the hip and 7.2% at the spine versus losses of 2.8% at the hip and 0.7% at the spine in the tamoxifen group (P<0.0001).

The ATAC trial recruited postmenopausal women with invasive primary breast cancer and randomized them to adjuvant treatment with Arimidex, tamoxifen, or combination therapy. The trial reported that Arimidex was superior to tamoxifen or combination therapy for preventing recurrence of breast cancer.

This 68-month subset analysis compared bone mineral density between 81 women treated with Arimidex and 86 women treated with tamoxifen. Lumbar spine and total hip bone mineral density were measured by dual-energy x-ray absorptiometry at baseline, one year, two years, and five years.

On the basis of these results, Dr. Coleman recommended that women taking Arimidex should have their bone mineral density monitored every one to two years. "They should also take calcium and vitamin D supplements during Arimidex therapy."

Oncologist Julie Gralow, M.D., of the University of Washington and Fred Hutchinson Cancer Center in Seattle said that women should also consider other ways to improve bone strength, "such as exercise and use of bisphosphonates."

J. Leonard Lichtenfeld, M.D., deputy medical director at the American Cancer Society, said the results should not be surprising because oncologists since have been long concerned about possible bone loss with aromatase inhibitors.

Primary source: American Society of Clinical Oncology
Source reference: Coleman RE et al "Effect of anastrazole on bone mineral density: 5-year results form "Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial" Abstract 511.