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Sunday, November 30, 2008

Varicella Outbreak Followed by Forced Vaccination

The only time I ever witnessed a severe reaction to chicken pox was in the 1970s while working in ICU at a hospital in Philadelphia. The wife of one of our GI doctors contracted chicken pox while pregnant. Sadly she died, but the baby survived. Her husband was devastated.

I had chicken pox as a child as did my children. Starch baths helped with the itching as I recall. We had no untoward effects, except that I experienced a shingles outbreak after my father died. But you can be sure I'm not heading out for the shingles vaccine.

Shingles is the same virus as chicken pox. The very painful patches can be treated naturally with valerian root and black walnut tincture. Additionally using St. John's Wort tincture acts as an anti-viral.

This recent event in Washington state shows how its health department is continuing to forcibly push vaccination without providing important vaccine information to parents. It also seems that in the usual style the health department isn't offering the no vaccination option, although the article mentions that the child can be kept at home.

The news station reported on this story while showing smiling children and the band aid covered spot on their arms. They did not provide the information that I've added below the report. You might want to read about problems with Varivax.

Other reports address a measles outbreak in the UK because people are not choosing the combined, yet problematic MMR jabs...

and some refer to the problems of Vaccines, adjuvants and potential toxicity
Spokane Regional Health District officials say at the very most two-dozen students at a north Spokane school have contracted chicken pox.

A letter was sent to parents at an elementary school in Spokane WA - instructing them to keep their children at home until the outbreak has ended if they can't provide proof of vaccination or immunity.

The decision is based on recommendations from the Centers for Disease Control and Prevention (CDC), and made in consultation with the Washington State Department of Health, and Spokane Public School officials.

A Spokane Regional Health District said only three classrooms have been affected by the outbreak thus far.

“Although many people believe that chickenpox is a mild, expected disease of childhood, chickenpox can be very serious,” said Bill Edstrom, epidemiologist for the Spokane Regional Health District.

“For this reason, Washington State began a phased-in requirement for all school children to be vaccinated against this disease beginning in 2005. Vaccine has been available and recommended for all children since 1995.”

During an outbreak, all children, staff and other adults who are working or volunteering in the affected classrooms who are at risk for the disease are recommended by the CDC to be sent home in order to stop the spread of the illness.

Currently, children and staff in affected classrooms without proof of vaccination or previous disease are being sent home for up to 21 days.

If the outbreak continues, this exclusion will be expanded to include all Garfield students and staff without proof of vaccination or previous disease.

A letter will be sent to parents today recommending that parents of all Garfield students prepare for the possible expansion of the outbreak and exclusion order.

It is not possible to predict who will have a mild case of chickenpox and who will have a serious or even deadly case of disease.

Even with uncomplicated cases, children with chickenpox miss an average of 5-6 days of school, and parents or other caregivers miss 3-4 days of work to care for sick children.

Compared with children, adults are at increased risk of complications related to chickenpox.

Vaccination is the best way to prevent infection with varicella—the virus that causes chickenpox—both in an individual and in the community.

Widespread vaccination also reduces the risk of exposure to infection for persons at risk for serious disease who cannot be vaccinated because of illness or other conditions.

The vaccine is safe and effective, and should be used to prevent as many cases as possible.

The varicella vaccine is available at most doctors’ offices, and at the Spokane Regional Health District’s public health clinic.

PASTEUR: Non-changeable microbes cause disease. Monomorphism. The Germ Theory.
BECHAMP: Microbes change. How - function of terrain. Pleomorphism. Terrain (toxicity) Theory.
Ultimately, Pasteur won, but reveresed himself on his deathbed, “...the microbe is nothing, the terrain is everything.”
Unfortunately, the road was paved for the Germ Theory and it was too late for medicine to turn it around.
RESULT: Medicine today alleviates symptoms of disease,but rarely the cause."

What You Should Consider Before Taking the Chicken Pox Vaccine (VARIVAX)

1) VARIVAX is recommended by Merck for children 12 months and older.

2) Chicken pox has a better than 99.99% compete recovery rate followed by life-time immunity.

3) The FDA VAERS' (Vaccine Adverse Events Reporting System) first year surveillance of VARIVAX included over 1,500 reports. 76 were serious adverse reactions that included 2 deaths. While a VAERS report does not prove a causal relationship between the vaccine and the death or disability that follows, the vaccine is highly suspect in all such reports.

4) The FDA has stated that fewer than 10% of serious adverse reactions and deaths following vaccines are reported; independent researchers cite lower rates. The federal government has paid families of vaccine killed and disabled children nearly $100 million in tax-payer dollars each year since 1986 through the National Vaccine Injury Compensation Program (NVCIP).

5) Studies show that up to 3% of VARIVAX recipients contract chicken pox from the vaccine, and that some chicken pox cases may be contracted from recently vaccinated children. Vaccine recipients may therefore pose a health risk to pregnant mothers or family members with chronic health problems or compromised immune systems.

6) VARIVAX has an estimated effectiveness of 6 - 10 years. Vaccinated children may thus be unprotected as adults, when hospitalization and deaths from chickenpox occur at rates 10 and 20 times higher than in childhood, respectively. (Half of the measles cases in the late 1980’s outbreaks occurred in adolescents and adults--most of whom were vaccinated as children.)

7) California’s Pacificare Health Systems HMO chose not to recommend VARIVAX; medical director Dr. William Osheroff said, “The real issue is all of the unanswered questions about Varivax...This is a very benign disease in children, but the vaccine may create a false sense of security as these kids get older and find themselves non-immune. Chickenpox as an adult is a serious disease.”

8) A 1995 edition of Health Magazine stated, “As with any new vaccine, researchers won't have complete information on its effectiveness until it's been in use for at least a generation.”

9) Some parents reported a correlation between VARIVAX and seizures. (The FDA Vaccine Data Safety Link has recently reported that seizures following DPT are “common,” although the DPT vaccine has been in use for decades.)

10) VARIVAX was developed with the use of aborted fetuses. This may pose religious and/or ethical considerations for some people.

11) Infants today may be protected from chicken pox by maternal antibodies from their mothers. However, due to VARIVAX's temporary immunity, vaccinated girls may not have maternal antibodies as adults. Their future children may be susceptible to chicken pox as infants, when they are too young for the vaccine. (The percentage of measles cases in infants has increased significantly in the years following the widespread use of the measles vaccine).

12) Shingles, a sometimes debilitating condition, is caused by the chicken pox virus. It usually occurs after age 50 in a tiny percentage of persons who had chicken pox as children. The relationship between VARIVAX (a live virus vaccine) and shingles is unknown. In 10 years of use, nearly 1 out of 1000 vaccine recipients have developed shingles. There is no way to know how many of the remaining 999 out of each 1000 will also develop shingles in later years.

13) According to the National Vaccine Information Center, many healthcare professionals are very concerned that the live vaccine virus may “reactivate later in life in the form of herpes zoster (shingles) or other immune system disorders.”

14) Dr. A. Lavin of the Department of Pediatrics, St. Luke’s Medical Center in Cleveland, Ohio, strongly opposed licensing VARIVAX, “Until we actually know...the risks involved in injecting mutated DNA [the vaccine] into the host genome [children].”

15) Some studies suggest that chicken pox in a vaccinated child may be milder than in an unvaccinated child. However, some experts believe that this may be due to the vaccine suppressing the illness, which could actually signal a more serious underlying chronic condition. For example, “Atypical measles” is a disease that occurs only in people previously vaccinated for measles, and it is far more serious than regular measles. It is not yet known if “atypical chicken pox” cases will appear as a result of the use of VARIVAX.

16) VARIVAX contains MSG (monosodium glutamate) in 2 forms, according to Jack Samuels, an expert on MSG. According to the FDA, MSG is not advised for infants, children, or pregnant women or children of childbearing age, and people with affective (mental/emotional) disorders.

17) According to VARIVAX product literature, the vaccine contains gelatin and trace amounts of neomycin, and should not be given to people allergic to them; it should not be given to anyone with an immune disorder, or anyone receiving drugs which affect the immune system such as chemotherapy or steroids; it should not be given to people with untreated tuberculosis or certain other infections.

18) Those who may suffer from any chronic condition or who are taking medicine on a regular basis (or whose family members do) should also consider avoiding this vaccine. (This page courtesy of Informed Parents Vaccine Information Home Page)

For more information:

Wednesday, November 26, 2008

Inhaled Steroids Bring Greater Risk of Pneumonia

Steroid inhalers may raise pneumonia risks
Nov. 26, 2008

BALTIMORE, Nov. 26 (UPI) -- Steroid inhalers, commonly prescribed for people with pulmonary disease, can increase the risk of pneumonia, U.S. researchers said.

The Johns Hopkins University study also found that while inhalers helped, they did not extend a patient's life after a year of use, The Baltimore Sun reported Wednesday.

While medical experts have known for years that inhalers are effective in treating wheezing and breathlessness brought on by chronic obstructive pulmonary disease, doctors raised questions about steroid inhalers' side effects and whether they extended a patient's life, said the study's lead author, M. Bradley Drummond, a pulmonologist at the Johns Hopkins School of Medicine.

In the study, investigators examined 11 clinical trials, including 14,426 patients, comparing the incidence of pneumonia in those who used inhalers against those who did not.

Researchers said they weren't sure why inhalers increased the risk of pneumonia, but one theory is that they may weaken a person's immune system.

"Because these agents are so effective at controlling symptoms, we do feel there is a good role for inhaled steroids for treating COPD," Drummond said. "But for some patients there may be more harm than benefits."

Drummond said patients who use inhalers should not stop doing so, but talk with their physicians if they have concerns.

Common trade names for this class of drug in the US include Beclovent, Flovent, and Pulmicort, Aerobid and Azmacort.

For one example, using Flovent, also known generically as fluticasone, this is a fluoride based product. There would be an additive factor in that inhaler propellants have traditionally been fluoride based solutions (two chlorofluorocarbon propellants: trichlorofluoromethane and dichlorodifluoromethane).

People using these products should be closely monitored for respiratory function but adrenal insufficiency as well as immune and thyroid function and bone density.

It is not enough that the steroid use can impair immune and endocrine function but bone health as well, especially when the products have a higher than average percentage of fluoride compounds.

More likely than not the higher risk of pneumonia could be correlated with steroid induced immune suppression. Data show upper respiratory infection as a major side effect.

Calcium and DHEA may be depleted using these products also.

Inhaled steroids in the mouth promote Candida albicans(yeast)infections there and also disperse steroids throughout the body(absorbed via the mucous membrane).

Politics, HIV/AIDS and GMO Drugs

The AIDS epidemic has been a world wide environmental and public health issue wince the concept was thrown out in the Nixon Administration by Henry Kissinger. It was Kissinger that led the Department of defense to a plan for bio warfare contaminants that have brought about HIV/AIDS issues.

This has been a boon to Big Pharma with an avenue for creating a profit stream with genetically engineered pharmaceuticals. It has become a political issue too as many reports address the difficulty some groups and nations have in obtaining the drugs.

In some way the drugs have helped, in others the drugs have harmed. This is similar to the interferon use that has been problematic for people with Hep C, MS and correlated "auto-immune" disorders.

For some time we have tried to get funding for an approach to HIV/AIDS that involves the use of supplements to prevent the conversion of HIV to AIDS. (Hope Bill and Melinda are reading this; Sir Elton and Oprah too!)

We also would like to see more respect for groups in Africa that are getting very good response to a mixture with garlic, cayenne, and some other natural ingredients. Beet, especially raw grated beet, is an excellent anti-cancer remedy, so it should encourage mainstream medicos to get a little more open-minded on the cultural approach to health care and healing. (Recall that the AIDS vaccine trial failed.)

Others are questioning the SOP. Could this be that there seem to be some anti-HIV/AIDS nutrients that can probably cure the "dis-ease".

There are four and they involve the glutathione peroxidase mechanism. The key core components are selenium, cysteine, glutamine and tryptophan.

Certainly this is a simpler, safer and very less expensive approach. It is not, however, expedient to Big Pharma, Bill Clinton or politics as usual, and perhaps not the UN agendae.

Recently the Well Being Journal, a publication that has printed a number of my articles, reported on this nutritional supplement regimen and its positive effects. You might find the material interesting reading and very useful. (Additional data)

Other non-SOP approaches are retained at Keep Hope Alive, where I have served as a medical advisor.

With all the benefits to so many from orthomolecular approaches over the past 60 or so years things might be opening up as chemical treatments fail and options dwindle to nothing.

This is just one quark of understanding the benefit of Chaos theory as applied to health and healing.
Universal HIV tests would have big impact: studyBy Michael Kahn Michael Kahn, Tue Nov 25, 2008
LONDON (Reuters) – Near-universal HIV tests and immediate drug treatment for people who test positive would almost eliminate transmission of the deadly virus within a decade, a computer model showed on Wednesday.

Doing this would cost more initially but then save money down the road because there would be fewer HIV-infected people to treat, Reuben Granich and colleagues at the World Health Organization wrote in the journal The Lancet.

The researchers emphasized their findings do not represent new WHO policy or any other guidance but rather stand as a call for discussion on how to better tackle the AIDS epidemic and the role of so-called antiretroviral drugs.

"Although other prevention strategies, alone or in combination, could substantially reduce HIV incidence, our model suggests that only universal voluntary HIV testing and immediate initiation of antiretroviral drugs could reduce transmission to the point at which elimination might be feasible by 2020 for a generalized epidemic, such as that in South Africa," they wrote.

Granich and colleagues used data from South Africa as a test case for a generalized epidemic in their model, which assumed all HIV transmission was through heterosexual sex.

This showed that voluntary screening in which at least 90 percent of the population took part, and immediate drug treatment for those testing positive, could reduce HIV transmission by more than 95 percent within 10 years.

The AIDS virus infects an estimated 33 million people globally, mostly in sub-Saharan Africa, and has killed 25 million. There is no cure.

The advent in the 1990s of combination drug therapy called highly active antiretroviral therapy, or HAART, has extended the lives of many HIV-infected people, particularly in developed countries.

About 3 million people worldwide had received the drug cocktails by the end of 2007, far short of the estimated 6.7 million infected people still in need of treatment, the researchers added.

There are, of course, drawbacks which the researchers and other scientists pointed out. One is how health systems in poor countries can cope with widespread testing, and whether people can stick to the drugs they must take for life.

"At its best, the strategy would prevent morbidity and mortality for the population, both through better treatment of the individual and reduced spread of HIV," Geoffrey Garnett, a researcher at Imperial College London, wrote in a commentary in The Lancet.

"At its worst, the strategy will involve over-testing, over-treatment, side effects, resistance, and potentially reduced autonomy of the individual in their choices of care."

(Reporting by Michael Kahn; Editing by Will Dunham and Mark Trevelyan)
Copyright © 2008 Reuters Limited

Faulty AIDS policies caused 365,000 early deaths in SAfrica: study

WASHINGTON (AFP) – The failure to provide anti-retrovirals to AIDS patients in South Africa led to the premature deaths of 365,000 people between 2000-2005, according to a new Harvard university study.

Researchers at the Harvard School of Public Health (HSPH) said the policies of Thabo Mbeki, who was heavily criticized during his 1999-2008 presidency for the denial of scientific remedies for AIDS, contributed directly to the deaths.

"Many lives were lost because of a failure to accept the use of available (antiretroviral drugs) to prevent and treat HIV/AIDS in a timely manner," researchers said.

Mbeki's health minister, Manto Tshabalala-Msimang, was widely discredited for proposing lemon juice, olive oil, garlic and beetroot as AIDS treatments as the country battled one of the world's worst AIDS epidemics.

Some 5.5 million of the 47 million population are infected by HIV -- over 18 percent of the adult population.

The study, published online last month and available Monday in the Journal of Acquired Immune Deficiency Syndromes, said the country lost at least 3.8 million years of life from the 330,000 adults who died for lack of proper treatment and the 35,000 babies who died after they were born with HIV.

For the study's model researchers compared the policies of the South African government with those of neighbouring Botswana and Namibia, which are suffering from comparable epidemics and did enforce a policy of treating patients with appropriate drugs.

According to the World Health Organization, 33 million people around the world are infected with the AIDS virus, mostly in the sub-Sahara Africa.

Some two million people died worldwide of AIDS in 2007.
Copyright © 2008 Agence France Presse

Tuesday, November 25, 2008

Exercise to Stay Healthy? Why of Course

Some years ago I was part owner in a Seattle business and was searching for a person to do our bookkeeping. My first stop on that search was the local senior center. And I lucked out!

I found a 76 year old retired banker who came to the office and we quickly started on a sound relationship. He did in two afternoons a week what it might have taken someone else five days.

And, even though he lived 17 blocks north and eight blocks east of the office he walked most of the way, only relying on the bus for a short part of the trip, both ways.

He told me one day that when he was younger the doctor told him that walking was the best thing he could do for his health, so he did it.

It is too bad that these researchers didn't know this fellow, but I'll vouch for the benefits.
Fitness and the Brain: Can a Walk a Day Keep Alzheimer's Away?

In the U.S. some five million people have Alzheimer’s disease and 10 million boomers will be at risk for memory problems over their lifetime. Worldwide, more than 100 million people may have Alzheimer’s by the year 2050. As clinicians, we have learned to recognize that jokes about “old-timer’s disease” and “Teflon brain” are often calls for help from seniors worried about their memory lapses. Living longer is obviously no fun if you cannot remember your home address or drive a car. Although we have made tremendous progress in understanding brain changes that accompany aging and dementia, no medications have proven effective for preventing Alzheimer’s to date. In recent years, however, more evidence is pointing to a non-medical way to bolster brain health as we age: exercise.

The Benefits of Exercise
Scientists are excited about the prospects of physical activity and exercise as anti-Alzheimer strategies for many reasons. Exercise training has been shown to reduce risk factors for dementia such as blood pressure, cholesterol, diabetes and depression. Studies in animal models of aging show that exercise can increase blood flow, stimulate nerve cell growth in regions associated with memory and reduce the pathologic changes characteristic of Alzheimer’s. Studies of exercise and memory in humans have been promising but not yet definitive. For example, some, but not all, observational studies of older adults time found that those who were more physically active (for example, in such activities as swimming, walking, ballroom dancing) or who exercised at least three times a week had a lower risk for dementia. Likewise some short-term clinical trials found that aerobic exercise improved certain cognitive abilities. The inconsistency across studies has hampered firm conclusions about the relevance of these findings, however. What was needed to move the field forward was a clinical trial testing whether regular exercise could produce sustained long-term improvements in older adults with memory problems.

In a study published in September 2008, Nicola Lautenschlager and colleagues at the University of Western Australia attempted to do just that. They studied 170 older people with memory complaints of whom 60 percent had objective memory deficits severe enough to be diagnosed with mild cognitive impairment, a condition thought to be a precursor for Alzheimer’s.

Over the next six months, half of the study participants were assigned to a home-based exercise program. They were encouraged to do at least three 50-minute sessions of exercise (mostly walking) each week. Those who were already doing this level of exercise at study entry (about 25 percent) were asked to up their activity level by an additional 50 minutes. The other half were assigned to receive basic health education as a control group. At the end of six months, exercisers improved modestly (scoring about 20 percent higher than controls) on an overall measure of cognitive abilities. The subgroup of people with mild cognitive impairment also improved. One year after the trial ended, the exercisers still sustained a 10 percent edge on overall cognitive score compared with controls and also had significantly less decline on a memory measure. A host of other cognitive subtests did not differ between the groups, however. This study is important because it is the first to demonstrate that exercise benefits cognition in older adults with subjective and objective memory problems over 18 months.

Further Questions
But this study was not a clean win and raises additional questions. The effect size was too small for an average person to be able to notice a benefit (although any effect is better than nothing in a field with no alternatives). Compliance with exercise decreases over time: Can we motivate people to sustain exercise habits over long periods? Are memory benefits seen only with aerobic exercise or can any type of physical activity help? This study did not follow people long enough to address the billion dollar question: Can regular exercise postpone the development of Alzheimer’s disease? The study by Lautenschlager and colleagues provides an important proof of principle and will help us design future trials to test these issues further. The availability of newer brain scans will also help us directly track whether exercise can affect the progression of Alzheimer brain pathology in people at risk. It has been said that “a man’s health can be measured by which he takes two at a time—pills or stairs.” As our society grows increasingly reliant on medications, lifestyle strategies such as exercise seem like, well, a no brainer.

P. Murali Doraiswamy, M.D. is head of the Division of Biological Psychiatry at Duke University and an author, with Lisa P. Gwyther and Tina Adler, of The Alzheimer's Action Plan, a consumer guide to memory problems. Benson Hoffman, Ph.D., is assistant clinical professor of Medical Psychology at Duke University.

Aspartame: Sweet, Sweet Poison

This is an article you most likely will never see in the US mainstream press.

You should however because aspartame is a toxic substance first developed as an insecticide, as was sucralose.

The article just might cause you to switch and lay off this chemical stuff that damages your mitochondrial DNA, leading to diseases of many kinds.

Just another way of covertly creating a cadre of lab rats, as I see it.
By Carlos H. Conde

During the past several weeks, an advertisement has been appearing in the Philippines’s major newspapers that extols aspartame, the artificial sweetener that goes by the brands Equal, Nutrasweet, to name two. The ad, about half a page in size, makes the assertion that aspartame is safe and that the food-and-drug regulatory agencies of the Philippines and of the United States, among other countries, have determined it to be so. The ad does not carry the name of any group or individual, thus it is safe to assume that the aspartame industry is behind it.

I am always convinced that if somebody tries to mislead the public, he would publish advertisements so frequently until the public accepts the ad’s assertion as the truth. This was the strategy that Joseph Goebbels used and perfected in selling Nazism to the German people. “If you tell a lie big enough and keep repeating it, people will eventually come to believe it,” Goebbels had said. This is the underlying principle of advertising and public relations.

The question is, Why would the makers of aspartame spend millions of pesos to convince the public about the safety of their product? Particularly at a time when the use of the sweetener, so far as I can tell, is exploding in the Philippines, what with Coca-Cola recently launching its Zero brand? Coke Zero, of course, uses aspartame.

I am sure the answer lies in the fact that there’s still much debate about the safety of aspartame.

Read the complete story here: Aspartame: Sweet, Sweet Poison.

Health Lobby Still Plans to Stick with Health Reform

With Tom Daschle now selected to head HHS, don't think he won't be followed by a pack of lobbyists. Don't expect anything different in the House or Senate.

The pack of thieves are circling the wagons, and guess who might just be the target...

I suppose if you say reform you have to ask by whose definition and on whose standards.

Daschle has been in a lobby group lately and he is for vaccines and mammogram.

Surely we can't believe that his tenure in the US Senate led him to stay clear of the rafts of rubles handed out by the lobby groups, even under the cover of supposed change and reform.

What happens can cgange but only if you are wililng to stand up to the status quo and fight for your health rights, level the playing field, and get the agenda to truly be people first!
Health Care Reform Stays in the Picture; Health Lobby Probably Does, Too
By Andrew Green
Conventional wisdom had it that the current economic morass might temporarily sideline President-Elect Obama’s push to reform health care. But today brings news that a handful of influential Washington players might not be willing to wait.

Senator Max Baucus, a Montana Democrat and the chairman of the Finance Committee, today released a 104-page position paper mapping his vision of health care reform. Meanwhile, Massachusetts Senator Ted Kennedy is convening a spectrum of stakeholders in hopes of getting legislation together by Obama’s inauguration, according to The Washington Post.

And health care reform advocates are likely not the only ones excited by this news. The health care lobby — one of Washington’s largest — is probably already gearing up for a fight similar to that of the early ’90s, when the Clinton administration unsuccessfully attempted to overhaul the health care system. The Center spent a year documenting the millions of dollars and thousands of hours spent lobbying various players in the health care reform effort, culminating in our 1994 report, Well Healed: Inside Lobbying for Health Care Reform.

The landmark investigation ripped the lid off the special-interest hijacking of the Clinton administration’s efforts to reconstitute our country’s health care system. Among its findings: At least 80 former congressional and executive branch officials had gone through the “revolving door” to work for health care interests. Almost a hundred public relations, lobbying, and law firms were hired to influence the debate. Hundreds of special interests cumulatively spent in excess of $100 million to affect the outcome.

Now, 14 years later, is there any doubt that those numbers will do anything but go up?

Breast Cancer, Natural Regression

Might this be a blow to the massive breast cancer industry if further study proves this finding.

If you follow this blog (4 pages of articles) and the long standing material found at you will know we stand behind the facts of mammogram as a cause of breast cancer.

We have been educating the public, and especially women, on this issue for at least 20 years. Our information has come from the 1960s HHS/FDA/CDC and other data provided to us during the years we worked in concert with the eminent researcher John Gofman, PhD, MD.

While others are claiming to be first up with the data we stand on our track record.

The data against mammogram has been known since the 1960s by the US government health agencies. Almost 50 years later the same campaign runs rampant.

In Spokane a woman who was diagnosed with breast cancer (I'd like to see that proof)was put through six rounds of standard treatemnt (SOP) including chemotherapy. She now has leukemia.

She prbably was never told that chemo is a causative factor for leukemia, and as the local news report stated, she has been fighting for months with insurance over a bone marrow transplant that could save her life.

This is SOP for insurers who manipulate their data to stave off treaments and payouts, even if it leads to death.

Had the TV station not gotten involved, the insurance company might not ever had started to back peddle on its denial scheme and approve treatment.

Of course the treatment is costly and of course the woman has, more likely than not, failed to be advised that IV vitamin C, B12 shots, thyroid support, T cell support and iodine just might help her out, along with solid nutriton and other natural therapy tailored for her situation; most aimed at correcting the deficiencies and damage caused by the exccessive chemo. And is she was treated at the Sokane area cancer center she probably was overloaded on chips and candy they offer during the chemo sessions that only feeds the cancer.

And you do have to ask, once again, did she really have it. And was she given all the information or even a chance for healing.

But then the woman most likele was never told mammogram causes breast cancer and the treatment statistics are so bad that it takes screening of 1,200 women for 14 years to save one life from breast cancer while during that time scores would suffer anxiety, surgery and mastectomies, chemo or radiation for suspicious lumps that turned out to be benign.

This new Norwegian study may support the 1970s data.
The researchers said their findings provide new insight on what is "arguably the major harm associated with mammographic screening, namely, the detection and treatment of cancers that would otherwise regress."

By Michael Kahn

LONDON (Reuters) - Researchers who tracked breast cancer rates in Norwegian women proposed the controversial notion on Monday that some tumors found with mammograms might otherwise naturally disappear on their own if left undetected.

But leading cancer experts expressed doubt about the findings and urged women to continue to get regular mammograms, saying this screening technique unquestionably saves lives by finding breast cancer early on when it is most treatable.

Dr. Per-Henrik Zahl of the Norwegian Institute of Public Health in Oslo and Norwegian and U.S. colleagues examined invasive breast cancer rates among nearly 120,000 women age 50 to 64 who had a mammogram -- an X-ray of the breast used to find evidence of cancer -- every two years over a six-year period.

They compared the number of breast cancers detected with another group of about 110,000 Norwegian women of the same age and similar backgrounds who were screened just once at the end of the six-year period.

The researchers said they expected to find no differences in breast cancer rates but instead found 22 percent more invasive breast tumors in the group who had mammograms every two years.

This raises the possibility that some cancers somehow disappear naturally, although there is no biological reason to explain how this might be, according to Zahl, whose findings were published in the Archives of Internal Medicine.

"We are the first ones to publish such a theory," Zahl said in a telephone interview. "What we say is many cancers must spontaneously disappear or regress because we cannot find them at later screenings. I have no biological explanation for this."

Mammography and breast self-examination for tumors are standard methods used for early detection of breast cancer, the leading cause of cancer deaths among women worldwide.

The American Cancer Society estimated that about 465,000 women die of breast cancer globally each year, and 1.3 million new cases are diagnosed.

"I think generally when we look at studies like this it is important to keep in mind there are some studies that change practice and others that make us think a little bit more, said Dr. Eric Winer, director of the Breast Oncology Center at Dana-Farber Cancer Institute in Boston.

"The idea that somehow these cancers go away entirely is, I would say, an intriguing hypothesis, but one we don't have a lot of evidence to support," said Winer, who was speaking on behalf of the American Society of Clinical Oncology.

In much of Europe women undergo mammograms every two years after age 50 except for in Britain where it is every three years, Zahl said. The American Cancer Society recommends that women get an annual mammogram beginning at age 40.

Bob Smith, director of cancer screening for the American Cancer Society, said Zahl's team misinterpreted the data, and expressed doubt about the idea that a significant number of breast tumors "spontaneously regress."

"I imagine there are still some people who believe the Earth is flat, but there are not very many of them," Smith said in a telephone interview. "It's not usual -- it happens every day that research is published that gets it wrong."

The researchers acknowledged many doctors might be skeptical of the idea but they cited 32 reported cases of a breast cancer regressing, a small number for such a common disease.

The researchers said their findings provide new insight on what is "arguably the major harm associated with mammographic screening, namely, the detection and treatment of cancers that would otherwise regress."

(additional reporting by Julie Steenhuysen; Editing by Will Dunham and Angus MacSwan)
© Thomson Reuters 2008 All rights reserved

It's Old News and You Aren't Getting It

This blog and material found on our original domain,, will help you find quite a bit of accurate, scientific information about viruses, cold and flu.

We aren't offering sensationalistic rants as seems to be the driving factor on some other sites. We offer facts and we try to provide information that will help you face health concerns in a more informed and educated approach. We also hope to encourage your enquiring mind so you will seek other corroboration.

Another medical colleague has provided some sound analysis on the current state of flu and vaccines. This doesn't surprise us because the track record for this vaccine, Tamiflu, has been abysmal if you have been tracking the data since the product got the FDA stamp to pass go in exchange for money.

Tamiflu really has been a failure for health but perhaps not for money.

However, since you most likely won't see these latest reports, we'll put them here for your edification.

And remember, the best prevention for flu is good health and sound nutritional status. If you get on this tract, you'll be amazed at the difference, and you'll save a bundle of money over the long term of a healthy life.

Commentary by Dr. Henry Niman

H1N1 Tamiflu Resistance Reporting Delays in North America
November 23, 2008

Based on the level of oseltamivir resistance observed in only one influenza subtype, H1N1, and the persisting high levels of resistance to the adamantanes in H3N2 viruses, CDC continues to recommend the use of oseltamivir and zanamivir for the treatment or prevention of influenza in the United States. Use of amantadine or rimantadine is not recommended.

The above comments from the latest influenza weekly report from the CDC comments on the levels of anti-viral resistance “observed”. However, reports from Europe and North America suggest that virtually all influenza A in the United States this season will be resistant to at least one anti-viral. The resistance rate for H3N2 for amantadines remains at or near 100%. Although test results for this season has been very limited, all H3N2 tested thus far has been resistant to amantadines. Similarly, last season the rate of resistance for the H1N1 sub-clade 2C (Hong Kong) was also 100%. Last season there were two H1N1 sub-clades in circulation in the US, and the rate of Tamiflu resistance for clade 2B (Brisbane/59) was around 10%. However, the level rose to 100% in several countries in the southern hemisphere in the 2008 season, and initial reports from Europe and North America (England, 12/13; Scotland, 2/2; Norway, 1/1; Canada, 1/1; United States, 1/1) suggest the level for clade 2B will be at or near 100% this season.

The numbers “observed” in the United States is low, because the reported number tested is low. In the latest report, the United States has reported 62 H1N1 isolates, but none have been tested for both oseltamivir and amantadine resistance. One isolate collected in September, prior to the official start of this flu season was amantadine resistance, strongly suggesting was clade 2C. One of two isolates tested for Tamiflu resistance this season had H274Y, and it is likely that the other will be amantadine resistant (but test results have not been released) and clade 2C.

Since the level of Tamiflu resistance is expected to be near 100%, it is somewhat surprising that more test results have not been released. The UK has issued an initial report on the 12/13 with H274Y in southwestern England, and has noted that two resistant isolates were also identified in Scotland, indicating the Tamiflu resistance is widespread.

Canada announced the resistance in its first influenza A isolate, but that was over a month ago, and Canada has also not released addition data. Thus, even though the Tamiflu resistance levels of clade 2B are expected to be at or near 100%, each country has only released test results on one clade 2B isolate, and both were resistant, consistent with frequencies reported in Europe this season.

Since most clinicians in North America are unaware of the expectation that the vast majority of Brisbane/59 H1N1 will be Tamiflu resistant, prompt release of test results would be useful.

Monday, November 24, 2008

Drug Trials Only Adverts?

An exquisite essay on just how it is!
Clinical Drug Trials: See them for what they often are — advertisements
by Warren Bell, MD

Just about every week, an announcement is made about research concerning some sort of new treatment. In just about every case, the treatment is a drug.

This does not mean, however, that drugs are the most important or valuable type of therapy, but rather that modernday, multi-national “big pharma” drug corporations have enormous, financial clout. Due to their patent-based monopolistic profits, drug companies earn 10 times more than all other types of treatment combined. Cnsequently, they can afford to hire the best advertising and public relations experts to relentlessly promote their products in the industry and public media.

So-called announcements from big pharma can more accurately be described as advertisements. They are, in point of fact, carefully crafted propaganda for the latest product generated by clever drug development teams, whose most important members are often public-relations experts and lawyers.

Reading between the profit lines

Let’s look at a hypothetical but typical drug announcement, one piece at a time:

“The results of a double-blind, multicenter trial of the new drug Zaronda, announced today by a research team at the University of Great Hill, reveal that this new breakthrough treatment significantly lowered levels of LDL cholesterol compared to placebo. Dr. Ronald McDonald, chief researcher and Head of the Department of Internal Medicine at UGH’s University Hospital, noted that this new drug represented “An exciting development in the battle against the growing epidemic of heart disease.”

Zaronda was developed in the research laboratories of Muck, Rake and Klink. Share values for the company rose 18 percent after the results of this study were announced.”

Double blind, multi-center trial:

This kind of phrase is used to make the ad sound scientifically impressive. “Double-blind” is thought of as the golden star of study models because neither the subject nor the researcher knows who is receiving the actual treatment in comparison to the placebo (dummy pill). The model and term are used in this case to create the impression of impartiality and rigour.

Multi-center trial: Using such a phrase suggests that large numbers of experimental subjects were involved, implying that it was a serious trial that cost a lot of money.

In actual fact, of course, size counts for nothing in many cases. In 1747, an experiment using only 12 subjects proved that limejuice prevents scurvy and ensured British naval dominance for 150 years.

The new drug: Drug companies want you to believe that what you’re reading about is “hot off the press,” creating the impression of excitement and hope.

Zaronda: Believe it or not, advertising geniuses in the drug industry have
figured out that certain letters are more “sexy.” The letters Z, X, and Y, for example, sell more drugs than most others. That’s why you see strange names for drugs, such as Xanax, Zostrix and Zyloprim.

Research team at the University of Great Hill: Drug companies know that there is still a veneer of respectability attached to educational institutions. They strive to mention either a university or hospital in association with any new drug research. Even if the research is carried out in the company’s own laboratories, the university or hospital connection will likely always come first.

Breakthrough: A key of almost all drug advertisements is the “breakthrough.”
Once again, the word creates the sense of excitement and drama that drug companies know will help to sell their product to desperate people. However, in a typical year, with say 800 new drug submissions, no more than half a dozen can actually be termed useful, let alone a breakthrough.

Significantly lowered levels of LDL cholesterol: Contrary to what many people think, high or low cholesterol is not a significant measure of your health, which makes this phrase a surrogate marker. Getting sick or dying is significant, but changing the amount of a substance in your bloodstream is not. (Some skeptical experts believe that there is no direct connection between cholesterol and heart disease.)

By taking advantage of the fact that many people—including many doctors—mistakenly
equate the lowering of cholesterol with improving a person’s health, drug companies cleverly create the impression that their drug can help. One of the most famous drug trials in medical history involved a drug that lowered cholesterol dramatically but markedly increased the number of deaths from gallbladder disease.

Compared to placebo: Here is one of the best tricks of the drug industry. Instead of comparing a new treatment to older, established treatments, the industry almost always compares a new product to a placebo. That way, they don’t have to worry that the public will compare the new drug to something already on the market—something that might be as good as the new product or even better.

Dr. Ronald McDonald... Chief...Head: The impression created here is of a researcher with an armload of qualifications and exceptional scientific expertise. What is never mentioned is that the good doctor is undoubtedly receiving substantial sums of money from the company making the drug being tested. Numerous studies in medical literature have shown that when this happens, research studies almost always show that the drug works well. He who pays the piper, plays the tune.

An exciting development in the battle against the growing epidemic of heart disease: Once again, this phrasing is attempting to drum up the impression of action, movement and excitement.

Heart disease is mostly caused by over consumption of food, lack of exercise and other lifestyle factors. Taking an expensive pill to deal with this behaviour can hardly be considered an effective weapon. Nevertheless, drug companies use military jargon and scare tactics to drum up business.

Share values for the company rose 18 percent: This kind of information is increasingly tagged onto the end of these ads. The fact that it’s there at all
reveals the true underlying purpose of these so-called treatment creations. They are designed to make money for shareholders of giant multinational corporations.

Patents for profit

By now you may think I’m against all drug companies, but I’m not. Evidence shows that approximately one percent of new drugs are significantly useful. I feel that the real problem with clinical trials is that the vast majority are done on patented drugs.

No one is eager to do trials on vitamins, herbal preparations, homeopathic remedies, physical therapies, or any of the other numerous non-pharmaceutical interventions that many people use every day. Why? Because the profit margin on these approaches
is trivial compared to the windfall profits earned by patented drugs.

If even one-tenth of the money currently wasted on patented drug trials were diverted into independent studies of natural health products, manual treatments and community health-related programs, therapy would be revolutionized overnight.

Treatments and interventions would become safer, less expensive, more accessible
and more sustainable.

Until that happens (and it will require public funding to be done properly)we’re going to have to go on swimming in a sea of flagrant advertisements for drugs of questionable value and unknown risk, disguised as legitimate.

My hope is that this article throws you a modest life raft to help you avoid

Warren Bell, MD, is a HANS member practicing in the heart of the Okanagan Valley. He’s also President of the Association of Complementary and Integrative Physicians of BC.
Courtesy magazine.

Natural Perspective on Gardasil

Sweden now will provide this vaccine free of charge. Perhaps they have over looked the facts and other risks.
Gardasil is a vaccination against human papillomavirus (HPV) that’s manufactured by Merck & Co. and marketed as “anti-cancer.” However, Canada has one of the lowest cervical cancer rates in the world.

In addition, 70 percent of women with HPV infection clear it spontaneously within one year, and 90 percent within two years.

This means that even if a woman has a high-risk strain of HPV, there is a very good likelihood that her immune system will be able to resolve it naturally.

The risk of any cervical disease is greatly decreased with a yearly Pap smear and safe sexual practices. There is a concern that this vaccine will give women a false sense of security and decrease yearly Paps and safe sexual practices.
Other factors that increase the risk of cervical cancers include:
long-term oral contraceptive use,
and nutritional deficiencies.

Addressing these factors, irrespective of vaccination, is very important.

Sunday, November 23, 2008

Correcting One of Those Cholesterol Myths

I notice from time to time that people are searching for information about keeping arteries clean and healthy. This may be associated with the rash of anti-cholesterol drug-dosing-on-a-rampage panic, or earnest queries.
Order lecithin granules through to help us continue this work.

I am not a fan of soy. It might be said that if I suggest a soy based supplement that I am ignoring my own best advice. My greatest concern about soy today are the facts that it is generally a GMO crop and it does have many negative health effects.

On the up side, a long used supplement, especially for those who have been convinced that eggs are evil, you might find some salvation in lecithin.

Lecithin is good for you in that it contains phosphatidyl choline, phosphatidyl inositol and essential fatty acids as linoleic acid in a tablespoon of granules. It also contains fish-oil-like, omega-3 linolenic acid. Any one of these substances is not found in a standard daily diet.

Choline & Inositol are essential for the breakdown of fats and cholesterol. And lecithin helps prevent arterial congestion, helps distribute body weight, increases immunity to viral infections, cleans the liver and purifies the kidneys.

Dr. Michael Sharon suggests that it "improves the condition of patients with neurological disorders such as tardive dyskinesia (a side effect of anti-psychotic drugs), Parkinson's disease and Alzheimer's disease or pre-senile dementia."

It may help with improving attention span which would certainly benefit ADD/ADHD issues.

Lecithin helps in maintaining the surface tension of cell wall membranes. Without enough lecithin, the cell wall hardens. This condition contributes to premature aging of the cells. The surface tension of the cell, maintained by lecithin is also responsible for transmitting nerve impulses and messages through or from the cell.

Udo Erasmus, PhD shares some lecithin function facts -
"Lecithin helps keep cholesterol soluble. In a food like eggs, which contain a large amount of cholesterol, it is especially important that lecithin be of high quality.

"Lecithin keeps cholesterol isolated from arterial linings, protects it from oxidation, and helps prevent and dissolve gall and kidney stones by its emulsifying action on fatty substances.

"Lecithin is necessary in our liver's detoxification functions, which keep us from slowly being poisoned by breakdown products of metabolic processes that take place in our body. Poor liver function is a common forerunner of cancer. According to some healers, cancer always involves the liver. Deficiency of either Choline or EFAs can induce cancer in experimental animals, and is likely involved in causing some human cancers.

"Lecithin increases resistance to disease by its role in our thymus gland. Here, EFAs are precursors of several prostaglandins, as well as being vital as part of the ammunition made by our immune cells to kill bacteria (fatty acid peroxides are used to produce bacteriocidal hydrogen peroxide).

"Lecithin is a phospholipid that makes up 22% of both the high density (HDL) and low density lipoprotein (LDL) cholesterol-carrying vehicles in our blood. These vehicles keep cholesterol and triglyceride fats in solution in our bloodstream and carry them to and from all parts of our body.

"Lecithin is an important part of membrane phospholipids that are involved in electric phenomena, membrane fluidity, and other functions for which EFAs are responsible.

"Finally, lecithin is an important component of bile. Its function in digestion is to break food fats into small droplets (emulsify them), to increase their surface area, speeding up the digestion of fats by enzymes."

Other helpful information about lecithin is that each serving (1 tbsp.) contains:
Choline 275 mg, Inositol 168 mg, Potassium 108 mg, Linoleic Acid (omega 6 EFA) 2,025 mg, Phosphatidylcholine 1,760 mg, Phosphatidylethanolamine 1,530 mg, Phosphatidylinositol 1,070 mg, Linolenic Acid (omega 3 EFA) 260 mg.

and Lecithin
Breaks up fats and cholesterol, Excellent for a healthy heart
Contains the Highest Phosphatide concentration available (98% or more!)
Is a Rich source of GLA (Gamma Linoleic Acid)
Helps the body utilize Vitamins A,D,E and K
Is Excellent for memory, concentration and recall
Cleanses liver and kidneys
Helps the body absorb nutrients

Lessen Chronic Inflammation
People whose diets supplied the highest average intake of choline (found in egg yolk and soybeans), and its metabolite betaine (found naturally in vegetables such as beets and spinach), have levels of inflammatory markers at least 20% lower than subjects with the lowest average intakes, report Greek researchers in the American Journal of Clinical Nutrition (Detopoulou P, Panagiotakos DB, et al.)

Compared to those whose diets contained <250 mg/day of choline, subjects whose diets supplied >310 mg of choline daily had, on average:

* 22% lower concentrations of C-reactive protein
* 26% lower concentrations of interleukin-6
* 6% lower concentrations of tumor necrosis factor alpha

Compared to those consuming <260 mg/day of betaine, subjects whose diets provided >360 mg per day of betaine had, on average:

* 10% lower concentrations of homocysteine
* 19% lower concentrations of C-reactive protein
* 12% lower concentrations of tumor necrosis factor alpha

Each of these markers of chronic inflammation has been linked to a wide range of conditions including heart disease, osteoporosis, cognitive decline and Alzheimer's, and type-2 diabetes.

In an accompanying editorial in the American Journal of Clinical Nutrition entitled, "Is there a new component of the Mediterranean diet that reduces inflammation?," Steven Zeisel from the University of North Carolina at Chapel Hill noted that choline and betaine work together in the cellular process of methylation, which is not only responsible for the removal of homocysteine, but is involved in turning off the promoter regions of genes involved in inflammation.

"Exposure to oxidative stress is a potent trigger for inflammation. Betaine is formed from choline within the mitochondria , and this oxidation contributes to mitochondrial redox status ," Zeisel continued.

"If the association between choline and betaine and inflammation can be confirmed in studies of other populations, an interesting new dietary approach may be available for reducing chronic diseases associated with inflammation," he concluded.

Recommended daily intakes of choline were set in 1998 at 550 milligrams per day for men and 425 milligrams a day for women. No RDI has been set for betaine, which, since it is a metabolite of choline, is not considered an essential nutrient.

Practical Tip: Egg yolks are the richest source of choline, followed by soybeans. Spinach, beets and whole wheat products are primary sources of betaine. (Olthof MR, van Vliet T, et al. J Nutr)

FDA Unapproved Drugs Cost Millions

Safety and Effectiveness are two keywords in the forefront at the FDA that seem to be disregarded.

This is not surprising at all since the real control over drugs and their use relies more on junque science from the pharmaceutical industry rather than the supposed watch-dog agency.

Certainly this is one more example of an ineffective bureaucracy that has little interest in either serving or protecting as is its mandate.

This isn't surprising under the lame duck administration we've all suffered under during the past eight years. What remains to be seen is how effective the new crew is going to be at bringing about massive change needed in this agency and others, or will we have MOS...

Find out about unapproved drugs - and be sure to let your members of Congress know just how you feel about this, especially those who struggle with the high cost of pharmaceuticals and Medicare's payola otherwise known as the Senior Drug Plan (D). Perhaps now that things are "changing" the deep hole might get filled in a bit.

Of course one thing you may want to consider is signing up for one of our natural health classes so that you can learn how to use natural health to get well and stay well in this toxic world.
Govt pays millions for unapproved drugsBy RICARDO ALONSO-ZALDIVAR and FRANK BASS, Associated Press Writers
23 November, 2008

WASHINGTON – Taxpayers have shelled out at least $200 million since 2004 for medications that have never been reviewed by the government for safety and effectiveness but are still covered under Medicaid, an Associated Press analysis of federal data has found. Millions of private patients are taking such drugs, as well.

The availability of unapproved prescription drugs to the public may create a dangerous false sense of security. Dozens of deaths have been linked to them.

The medications date back decades, before the Food and Drug Administration tightened its review of drugs in the early 1960s. The FDA says it is trying to squeeze them from the market, but conflicting federal laws allow the Medicaid health program for low-income people to pay for them.

The AP analysis found that Medicaid paid nearly $198 million from 2004 to 2007 for more than 100 unapproved drugs, mostly for common conditions such as colds and pain. Data for 2008 were not available but unapproved drugs still are being sold. The AP checked the medications against FDA databases, using agency guidelines to determine if they were unapproved. The FDA says there may be thousands of such drugs on the market.

Medicaid officials acknowledge the problem, but say they need help from Congress to fix it. The FDA and Medicaid are part of the Health and Human Services Department, but the FDA has yet to compile a master list of unapproved drugs, and Medicaid — which may be the biggest purchaser — keeps paying.

"I think this is something we ought to look at very hard, and we ought to fix it," said Medicaid chief Herb Kuhn. "It raises a whole set of questions, not only in terms of safety, but in the efficiency of the program — to make sure we are getting the right set of services for beneficiaries."

At a time when families, businesses and government are struggling with health care costs and 46 million people are uninsured, payments for questionable medications amount to an unplugged leak in the system.

Sen. Charles Grassley, R-Iowa, has asked the HHS inspector general to investigate.

That unapproved prescription drugs can be sold in the United States surprises even doctors and pharmacists. But the FDA estimates they account for 2 percent of all prescriptions filled by U.S. pharmacies, about 72 million scripts a year. Private insurance plans also cover them.

The roots of the problem go back in time, tangled in layers of legalese.

It wasn't until 1962 that Congress ordered the FDA to review all new medications for effectiveness. Thousands of drugs already on the market were also supposed to be evaluated. But some manufacturers claimed their medications were "grandfathered" under earlier laws, and even under the 1962 bill.

Then, in the early 1980s, a safety scandal erupted over one of those medications. E-Ferol, a high potency vitamin E injection, was linked to serious reactions in some 100 premature babies, 40 of whom died.

In response, the FDA started a program to weed out drugs it had never reviewed scientifically. Yet some medications continued to escape scrutiny.

Sometimes, the medications do not help patients. In other cases, the FDA says, they have made people sicker, maybe even killed them. This year, for example, the FDA banned injectable versions of a gout drug called colchicine after receiving reports of 23 deaths. Investigators found the unapproved drug had a very narrow margin of safety, and patients easily could receive a toxic dose leading to complications such as organ failure.

Critics say the FDA's case-by-case enforcement approach is not working.

"The FDA does not appear to have a systematic mechanism to report these drugs out," said Jon Glaudemans, senior vice president of Avalere Health, a health care industry information company, "and there doesn't seem to be a systematic process by which health insurance programs can validate their status. And everyone is pointing the finger at someone else as to why we can't get there."

In most cases, doctors, pharmacists and patients are not aware the drugs are unapproved.

"Over the years, they have become fully entrenched in the system," said Patti Manolakis, a Charlotte, N.C., pharmacist who has studied the issue. Only a few unapproved drugs are truly essential and should remain on the market, she added.

Tackling the problem is made harder by confusing — and sometimes conflicting — laws, regulations and responsibilities that pertain to different government agencies.

Medicaid officials said their program, which serves the poor and disabled, is allowed to pay for unapproved drugs until the FDA orders a specific medication off the market. But that can take years.

Compare that with Medicare, the health care program for older people.

Medicare's prescription program is not supposed to cover unapproved drugs. Medicare has purged hundreds of such medications from its coverage lists, but continues to find others.

It might be easier to sort things out if the FDA compiled a master list of unapproved drugs, but the agency hasn't. FDA officials say that would be difficult because many manufacturers do not list unapproved products with the agency. Yet, the AP found many that were listed — a possible starting point for a list.

Among the drugs the AP's research identified were Carbofed, for colds and flu; Hylira, a dry skin ointment; Andehist, a decongestant, and ICAR Prenatal, a vitamin tablet. Medicaid data show the program paid $7.3 million for Carbofed products from 2004 to 2007; $146,000 for Hylira; $4.8 million for Andehist products, and $900,000 for ICAR.

Grassley said the system is failing taxpayers and consumers.

"The problem I see is bureaucrats don't want to make a decision," Grassley said. "There is no reason why this should be such a house of mirrors when so much public money is being spent." Grassley is considering introducing legislation to ensure that consumers are told when a medication is unapproved.

FDA officials say they tell Medicaid and Medicare when the agency moves to ban an unapproved drug, so the programs can stop paying.

"The situation is complicated by the fact that Medicaid and Medicare have a different regulatory regime than FDA does," said FDA compliance lawyer Michael Levy. "There are products that we may consider to be illegally marketed that could be legally reimbursed under their law."

The FDA began its latest crackdown on unapproved drugs two years ago and has taken action against nine types of medications and dozens of companies. Typically, the agency orders manufacturers to stop making and shipping drugs, and it also has seized millions of dollars' worth of medications. But federal law does not provide fines for selling unapproved drugs, and criminal prosecutions are rare.

Some manufacturers of unapproved drugs say their products predate FDA regulation and are "grandfathered in."

"These are drugs that don't require an FDA approval," said Bill Peters, chief financial officer of Hi-Tech Pharmacal in Amityville, N.Y. "These are products with active ingredients that have been on the market for a long time." The company is moving away from older products, Peters said, and its new market offerings are FDA-approved.

Levy said the FDA is skeptical that any drugs now being sold are entitled to "grandfather" status. To qualify, they would have to be identical to medications sold decades ago in formulation and other important aspects.

The agency is targeting drugs linked to fraud, ones that do not work and, above all, those with safety risks. While the crackdown has helped, it does not appear to have solved the problem.

The gout drug banned by the FDA this February is not the only recent case involving safety problems.

Last year, the FDA banned unapproved cough medicines containing hydrocodone, a potent narcotic. Some had directions for medicating children as young as age 2, although no hydrocodone cough products have been shown to be safe and effective for children under 6.

In a 2006 case, the agency received 21 reports of children younger than 2 who died after taking unapproved cold and allergy medications containing carbinoxamine, an allergy drug that also acts as a powerful sedative. Regulators banned all products that contained carbinoxamine in combination with other cold medicines.

"We as Americans have a belief that all the prescription drugs that are available to us have been reviewed and approved by the FDA," said Manolakis, the pharmacist. "I think the presence of these drugs shows we have a false sense of security."

Thursday, November 20, 2008

Gingko Study Leaves Much to Be Considered

It is interesting to note that Schwabe supplied the gingko tablets for this study. As a pharmaceutical company it has had a financial interest in the Nature's Way brand for some years. It is a German company that focuses on standardized herbal products because of the impact of Commission E and CODEX in that country.

This makes a major difference in the outcome of any study that looks at possible treatments for a disease condition. The low does rate of a 120 mg. tablet is also an issue; the dose may just be too low to achieve any benefit.

Most traditional herbalists would not suggest the use of a standardized product for starters, except in very specific situations. The push to standardized herbal products has come about in an effort to isolate certain factors, generally single elements, found in whole herb products that are thought to be the "effective ingredient". This makes them behave more like drugs rather than herbs.

Gingko can provide antioxidant protection, support normal memory function, promote mental clarity, maintain healthy eyes, support normal hearing function, support the body as it ages, help maintain proper energy, support a healthy cardiovascular system, support healthy blood function, support healthy oxygen flow to the brain and peripheral areas of the body.

Gingko or Gingko biloba as it is commonly known is a popular herb that comes from the gingko biloba tree found throughout the world. It is a herb which has been used for 5,000 years by humans, especially in Chinese or Oriental medicine. It is the most popular prescription drug in Germany and France for symptoms of aging in association with deteriorating memory. In 1988 it was prescribed more than 5 million times in Germany alone. Not only is it used for improved memory functions but it possesses properties which improve blood circulation.

Hundreds of scientific papers have been published on ginkgo, confirming that ginkgo stimulates blood flow to the brain by dilating blood vessels, decreasing platelet aggregation, and being a powerful antioxidant to block oxidation of the fatty cell membrane.

As a result, it improves cerebral vascular insufficiency, memory and peripheral circulation in conditions such as intermittent claudication.

Gingko is not recommended during pregnancy and lactation.

You may read more about gingko here.

In our work we prefer to utilize liquid herbal extracts and sometimes herbal capsules that are a combination of the complete extract and whole herb. We also custom blend combination formulas based on client needs. We also would not hang our hat on the results of this study by failing to offer gingko to people with Alzheimer's disease if the situtaion dictated it.

Referring to the "blood thinning" function of gingko, it may, like vitamin E and other natural products, be a safer alternative to aspirin and warfarin or drugs such as Plavix in the long term.

Ginkgo fails to prevent Alzheimer's in large studyBy CARLA K. JOHNSON, Associated Press Writer
Tue Nov 18, 2008

CHICAGO – The dietary supplement ginkgo, long promoted as an aid to memory, didn't help prevent dementia and Alzheimer's disease in the longest and largest test of the extract in older Americans. "We don't think it has a future as a powerful anti-dementia drug," said Dr. Steven DeKosky of the University of Virginia School of Medicine, who led the federally funded study.

Extracts from ginkgo tree leaves have antioxidant and anti-inflammatory effects, but earlier research on ginkgo and memory showed mixed results. Annual U.S. sales of the supplement reached $107 million in 2007, according to Nutrition Business Journal estimates.

For the new study, appearing in Wednesday's Journal of the American Medical Association, researchers recruited more than 3,000 people, ages 75 and older, from voter and mailing lists in Maryland, Pennsylvania, California and North Carolina.

Half were randomly assigned to take 120 milligrams of ginkgo biloba twice a day, a typical dose taken by people who think it may help memory. The others took identical dummy pills.

Participants were screened for dementia every six months. After six years, dementia had been diagnosed at a similar rate in both groups; 277 in the ginkgo group and 246 in the group taking the dummy tablets. When the researchers looked only at Alzheimer's disease, that rate too was similar.

At the start, some people showed mild difficulties with thinking; ginkgo didn't work to prevent dementia in those people either.

Ginkgo appears relatively safe, DeKosky said. There was no difference in the rate of adverse events such as heart attacks and gastrointestinal bleeding between the groups. There were 16 strokes from bleeding in the brain in the ginkgo group versus eight in the placebo group, a difference that wasn't statistically significant, he said, because the number of strokes was too small.

People on the blood thinner warfarin shouldn't take ginkgo because of the risk of increased bleeding.

Proponents claim ginkgo protects the brain by preventing the buildup of an Alzheimer's-related protein or by preventing cell-damaging oxidative stress.

Would ginkgo work better to prevent dementia if people started taking it earlier, say, in middle age? The study didn't look at that, DeKosky acknowledged, adding that following people for 25 years from middle age to old age would be expensive research. The study also didn't test whether ginkgo improves thinking and memory in the short term.

"It would have been terrific if this worked. It's inexpensive, available and relatively safe," said Paul Solomon, professor of neuroscience at Williams College in Williamstown, Mass., who wasn't involved in the new study but has studied ginkgo.

"Now with this kind of evidence, you can confidently tell people it didn't show benefit in more than 3,000 people in six years of research," Solomon said.

There may still be a role for ginkgo in treating, rather than preventing, Alzheimer's disease, said Michael McGuffin, president of the American Herbal Products Association, a trade association.

Some previous ginkgo trials have shown no benefit in Alzheimer's symptom treatment, while others have found it comparable to prescription drugs such as Aricept, also known as donepezil.

A four-month supply of ginkgo can cost less than $10. But not all brands contain what their labels claim., which tests the ingredients in supplements, reported Tuesday that of seven ginkgo products it reviewed, five failed to pass its tests. An eighth ginkgo product also passed the group's test in a voluntary certification program.

The dementia study was funded by a grant from the National Institutes of Health's National Center for Complementary and Alternative Medicine, which is undertaking large, scientific tests of a number of commonly used dietary supplements. The agency said it's the largest-ever randomized trial of a botanical medicine. There have been larger studies of vitamins and minerals.

DeKosky reported receiving grants from and acting as a consultant for several drug companies, including some that make dementia drugs. Schwabe Pharmaceuticals of Karlsruhe, Germany, provided the ginkgo tablets and identical placebos.

On the Net: JAMA:
Ginkgo fact sheet:
Copyright © 2008 The Associated Press.

Wednesday, November 19, 2008

Black Box for Avastin

We reported earlier this year that the FDA approved Avastin, manufactured by Genentech, for breast cancer treatment. It had been previously approved for colon and lung cancer treatment.

Today, UPI reports that a panel had recommended that Avastin needs a Black Box warning.
Study says Avastin needs black box warningPublished: Nov. 19, 2008
NEW YORK, Nov. 19 (UPI) -- A drug touted as a safer, gentler way to treat cancer increases the risk of blood clots, a U.S. study in the Journal of the American Medical Association said.

A study showed about 12 percent of the people taking Avastin developed blood clots in the veins, which is a rate that's 30 percent higher than among patients not taking the drug, USA Today reported.

Because clots are among the leading causes of sickness and death among cancer patients, the study's authors recommended Avastin get the U.S. Food and Drug Administration's strongest warning, known as a "black box" warning.

Avastin is among the new "targeted therapies" billed as a safer and gentler alternative to traditional chemotherapy, USA Today said.

Doctors didn't know the magnitude of Avastin's risks until now because earlier studies were too small to show a trend, co-author Shenhong Wu of New York's Stony Brook University said. Wu says his study results are strong because he pooled results of 15 well-designed trials with nearly 8,000 patients.

A spokeswoman for the drug's maker Genentech said Avastin's label already warns about the risk of blood clots, which can be treated or prevented with blood-thinners, the spokeswoman said.

In the mean time, what you aren't hearing from the FDA is that there is another cancer cure that is available, like so many the FDA already holds from the public doamin.

Daschle at HHS?

Tom Daschle, former Senate Majority Leader from South Dakota, gives his objectives in a June 2008 speech. His analysis of the health care crisis is this:

Daschle is for fluoridation which is known NOT to prevent cavities; it causes many other severe health problems. The fluoride based drugs cause problems as well.

Maybe if RFK is open to overseeing EPA we can get rid of fluoride once and for all.

Daschle is for mammogram which the FDA has always known the procedure promotes breast cancer.

Electronic records are known to be easily hacked. The data is also collected and sold or otherwise circulated without your permission. HIPPA saw to this little hidden fact.

What are Daschle's ideas on supplement parity and protected access to services outside the medical mafia?

Lots of questions need to be asked.

Maybe he is the political pick but are his ideas too out of date. Is he really reading the research or just parroting what he's been given from the propaganda grist mill at CDC et al?
US Healthcare has three major problems: 1) Cost containment. We spend $8000/capita – 40% more than the next most expensive country in the world (Switzerland). Last year businesses spent more on healthcare than they made in profits. General motors spends more on healthcare than they do on steel.

2) Quality control. The US system cannot integrate and create the kind of efficiencies necessary. The WHO has listed us as 35 in overall health outcomes. Some people ask, "If we have a quality problem, why do kings and queens come to the US for their healthcare?" They come to the best places like the Mayo Clinic, the Cleveland Clinic, or Johns Hopkins. They don't go to rural South Dakota. We have islands of excellence in a sea of mediocrity.

3) Access. People are unable to get insurance if they have a pre-existing condition. 47 million people don't have health insurance. We have a primary care shortage, and hospitals turning away patients because they're full.

His solutions are these:

Universal coverage. If we don't have universal coverage we can't possibly deal with the universal problems that we have in our country.

Cost shifting is not cost savings. By excluding people from the system we're driving costs up for taxpayers – about $1500/person/year.

We must recognize the importance of continuity of care and the need for a medical home. Chronic care management can only occur if we coordinate the care from the beginning, and not delegating the responsibility of care to the Medicare system when the patient reaches the age of 65.

We must focus on wellness and prevention. Every dollar spent on water fluoridation saves 38 dollars in dental costs. Providing mammograms every two years to all women ages 50-69 costs only $9000 for every life year saved.

Lack of transparency is a devastating aspect of our healthcare system. We can't fix a system that we don't understand.

Best practices – we need to adopt them.

We need electronic medical records. We're in 21st century operating rooms with 19th century administrative rooms. We use too much paper – we should be digital.

We have to pool resources to bring down costs.

We need to enforce the Stark laws and make sure that proprietary medicine is kept in check.

We rely too much on doctors and not enough on nurse practitioners, pharmacists, and physician assistants. They could be used to address the primary care shortage that we have today.

We have to change our infrastructure. Congress isn't capable of dealing with the complexity of the decision-making in healthcare. We need a decision-making authority, a federal health board, that has the political autonomy and expertise and statutory ability to make the tough decisions on healthcare on a regular basis. Having this infrastructure in place would allow us the opportunity to integrate public and private mechanisms within our healthcare system in a far more efficient way.

Big Insurance Seeking Spoils

While the Obama transition team wields the ugly power of spoils for the victor, all those with vested interests are jockeying viciously for position.

And while everyone seems to have been spoon fed on the idea of national health insurance, Big Insurance is seeking an eye on profits as it uses ploys that are trendy and seem to get them a big payoff for superficial pandering with their manipulated media statements in line with what their pundits think COngress will swallow.

Of course Hillary is back in this fray, trying to cut deals, hubby Bill trying to cut deals, and Teddy Kennedy seemingly blocking some of them.

Kennedy has been wheeling and dealing with the big players on a health plan, but you can be sure it isn't with Joe and Jane Six-Pack in mind.

Maybe its more like roulette, le juet sont fait!

I'm not against everyone having access to care, but the question has to be who really is controlling the care.

The Hillary Plan was dead before it started in her husband's administration. Has she really kept in touch with the "outside" over all these years to allow her to start on this with a clean slate?

We need reform on many levels. Reform requires new ideas and fresh folks who aren't mired in the Beltway Bandit band and their tunnel vision.

If you haven't been keeping up with the G8 that is now the G20, you do need to know what their plan is and how it will effect your health. If you dare to risk reading much more truthful interpretations of their actions than what you'll ever read or hear in the media as it is today start here.
Insurers make pitch for health coverage mandate
By KEVIN FREKING, Associated Press Writer

WASHINGTON – The health insurance industry says it will support a national health care overhaul that requires them to accept all customers regardless of pre-existing medical conditions.

In return, the industry said Wednesday, it wants Congress to require that everyone buy coverage.

Lawmakers have signaled their intent to craft health care legislation early next year, and the insurance industry's support would make passage much easier. That legislation is expected to closely track the proposals of President-elect Barack Obama.

Karen Ignagni, president of the board of directors for America's Health Insurance Plans, says she hopes the endorsement will help members of Congress fashion their proposal.

Splenda Lawsuit Agreement Not to be Disclosed

Yes sucralose, or Splenda, is a chlorinated hydrocarbon first developed as an insecticide. We certainly wonder why the terms of the settlement are confidential as the data may impact consumer health and should be public.

I does have some untoward effects on health which may have been concealed from the FDA at the time the manufacturer was seeking approval.

Splenda is known to cause seizures, shrinkage of the thymus gland, effects endocrine function, may lead to liver swelling and calcification of the kidneys. The chemical structure is 1,6chloro-1,6-dideoxy-beta-D-fructofuranosyl-4-chloro-4-deoxy-alpha-D-galactopyranoside. More information on sucralose can be found here: Holistic Med.

Safeer and natural sweeteners are agave, Just Like Sugar or stevia.

McNeil Nutritionals and the Sugar Association Inc. jointly announced Monday that they have reached a settlement of a lawsuit regarding the sugar substitute Splenda marketed by McNeil.

Terms of the settlement are being kept confidential.

The association sued McNeil in 2004 claiming McNeil falsely promoted Splenda as a natural product “made from sugar, so it tastes like sugar.” The association argued in its lawsuit that Splenda is actually a chlorinated, artificial sweetener.

McNeil filed its own lawsuit against the Sugar Association in 2005 accusing the association of conducting a “smear campaign” against Splenda and creating a Web site,, that contained allegedly false statements about the product.

The details of the settlement agreement have been filed at U.S. District Court for the Central District of California.

The Sugar Association, a Washington, D.C., trade group that represents the sugar industry, and McNeil said they have agreed to make no additional comments on the terms of the settlement.

McNeil Nutritionals, of Fort Washington, Pa., is a division of Johnson & Johnson (NYSE:JNJ) of New Jersey.

Philadelphia Business Journal - November 17, 2008
© American City Business Journals Inc.

Tuesday, November 18, 2008

Diabetes Cost Continues to Rise

Preventing complications of diabetes is a very important issue. Preventing diabetes is much more important. Worker productivity certainly may be a concern but should rank at the bottom of the list.

Prevention would be the focus. Newer drugs should be limited in use and older, less costly yet more effective drugs should be used when at all possible.

Big Ag should be banned from its control at the USDA in regard to food processing and food ingredients that promote the disease.

Aspartame and sucralose should be banned as the FDA does know of the devastation these chemicals pose. High fructose corn syrup should be included as well in the ban.

Natural therapies that are available to help prevent neuropathy are available. Other natural therapies to reduce blood sugar levels should be established as options.

Thorough endocrine evaluations should be offered because diabetes can be associated with low adrenal and low thyroid function.

And the US health care system can do better to improve the low raking it has in regard to improving health of those with chronic disease.
Study puts a total on diabetes cost: $218 billion
By LINDA A. JOHNSON, AP Business Writer
Tue Nov 18, 2008

TRENTON, N.J. – As diabetes is rapidly becoming one of the world's most common diseases, its financial cost is mounting, too, to well over $200 billion a year in the U.S. alone.

A new study, released Tuesday exclusively to The Associated Press, puts the total at $218 billion last year — the first comprehensive estimate of the financial toll diabetes takes, according to Danish pharmaceutical company Novo Nordisk A/S, which paid for the study.

That figure includes direct medical care costs, from insulin and pills for controlling patients' blood sugar to amputations and hospitalizations, plus indirect costs such as lost productivity, disability and early retirement.

The study, conducted by the Lewin Group consultants, estimates costs to society for people known to have Type 1 or Type 2 diabetes at $174.4 billion combined, a total previously reported by Novo Nordisk, the world's top producer of insulin and the maker of diabetes pills such as NovoNorm and Prandin. That study was done with the American Diabetes Association.

The new study adds estimates for people who haven't been diagnosed yet ($18 billion), women who develop diabetes temporarily during pregnancy ($636 million) and those on track to develop diabetes, an increasingly common condition called pre-diabetes ($25 billion).

"Diabetes has not seen a decline or even a plateauing, and the death rate from diabetes continues to rise," said Dana Haza, senior director of the National Changing Diabetes Program, an effort Novo Nordisk began in 2005 to improve diabetes care and prevention in the U.S.

"The numbers just keep going higher and higher, and what we want to say is, 'It's time for government and businesses to focus on it,'" said Haza, who believes diabetes will be the country's biggest health problem in the future, worsened by the obesity epidemic.

Novo Nordisk is to present the data Tuesday at a health care conference for corporate executives and then plans to publish a full report in a professional journal. The calculations are based on numbers from sources including databases on treatment of people with commercial insurance, Medicare and Medicaid, federal public health surveys and other sources.

Andrew Webber, president and chief executive of the National Business Coalition on Health, said the study is the first he's seen estimating diabetes costs. He praised its inclusion of indirect costs, which "add up and create such a powerful argument as to why employers need to take this challenge on."

"This study gives a very persuasive argument to employers to invest in a culture of health in their workforce," Webber said, calling the worsening diabetes epidemic "the tsunami that is coming."

Among people known to have diabetes, the new study estimated $10.5 billion in medical costs and $4.4 billion in indirect costs, or a total of $14.9 billion, for people with Type 1 diabetes, which generally begins in youth and can have a genetic link. Nearly 6 percent of the 17.5 million Americans diagnosed with diabetes have Type 1.

The study estimated $105.7 billion in medical costs and $53.8 billion in indirect costs, totaling $159.5 billion, for people with Type 2 diabetes, previously called adult-onset diabetes because of its link to the bigger waistlines and sedentary lifestyles.

The National Changing Diabetes Program, which includes medical partners such as the American Academy of Family Physicians and American Diabetes Association, wants more Americans at risk of diabetes to know their blood sugar level and control it. It also wants the White House to appoint a coordinator for diabetes prevention and education.

Meanwhile, plenty of companies have started their own efforts, said Webber, whose group includes 61 business coalitions with about 7,000 employers and 35 million employees and dependents.

Webber said six of those coalitions are running programs giving participating employees diabetes medicines without a co-pay, six more give doctors extra money for helping patients get their diabetes under control, and one coalition offers both types of programs.

"My guess is we need to do both," to prevent complications and improve worker productivity, Weber said.

On the Net: National Changing Diabetes Program,
Copyright © 2008 The Associated Press.

Bone Loss Problematic, Bone Drugs Risky

In January 2008 the FDA issued warnings regarding the class of drugs developed to allegedly help people with osteopenia and osteoporosis.

Numerous problems are associated with these drugs, including bone frailty and increased fracture rates.

Now chemotherapy for cancer seems to be opening a new window to ply these drugs on patients who already are health compromised because of the cancer and chemotherapy drug treatments.

It is interesting to note that there does exist a safe and effective approach to maintaining storng, healthy and flexible bones with vitamins and other natural supplements.

Some other physicians express concern -"
Bisphosphonates, like Fosamax and Actonel, are taken up by osteoclasts with resulting loss of osteoclast activity and inhibition of bone resorption, and bone remodeling (link). Although DEXA scanning confirms increased bone density and studies such as the FIT suggest reduced fracture rate, Susan Ott, MD raises questions about the long term safety of bisphosphonates. Although the bisphosphonates appear to have short term benefits, she speculates that after 5 years of use, there is severe suppression of bone formation with negative effects such as microdamage and brittleness.

Jennifer P. Schneider, MD, PhD reports a 59-year old previously healthy woman on long-term alendronate. While on a subway train in New York City one morning, the train jolted, and the woman shifted all her weight to one leg, felt a bone snap, and fell to the floor, suffering a spontaneous mid -femur fracture (see image). In the months following, it became clear that the fracture was not uniting. Schneider speculates that increased bone density from the bisphosphonate drug does not necessarily equate with good bone quality. By decreasing osteoclast activity and bone resorption, and therefore bone formation as well, microdamage, and brittle bone may result in fractures.

Odvina reports on 9 cases of spontanous fracture while on alendonate. Five of the nine cases were spontaneous mid femur fractures. Two had bilateral mid femur fractures same as Toulouse Lautrec. Six cases had delayed or absent fracture healing. Histomorphometric analysis of the cancellous bone showed markedly suppressed bone formation, and Odvina raised the possibility that severe suppression of bone turnover could develop during long-term alendronate therapy, resulting in increased susceptibility to, and delayed healing of, nonspinal fractures.

Dimitrakopoulos reports on 11 patients presenting with necrosis of the jaw, claiming this to be a new complication of bisphosphonate therapy administration, i.e. osteonecrosis of jaws. He advised clinicians to reconsider the merits of the rampant use of bisphosphonates. Osteonecrosis of the jaw is a common finding in pycnodysostosis. The bisphosphonates recreate the same clinical p rofile of spontaneous mid femur fractures, failure of bone healing and jaw necrosis which tormented Toulouse Lautrec.

In spite of this well known information, there are four more drugs in clinical trials which are specifically designed to inhibit cathepsin K, the enzyme defect in Lautrec's genetic bone disease. FDA approval for use in osteoporosis treatment is expected. Excuse me here, but perhaps this thinking needs re-evaluation. In essence we are creating a population of women with Toulouse Lautrec's bone disease. Ironically, women who sustain fractures while on Fosamax are told by their docs that the fractures are due to the underlying osteoporosis, not the drug. "

Cancer Treatment May Result In Bone Loss, Study Finds

ScienceDaily (2008-11-17) -- A new cross-Canada study has found that breast and prostate cancer treatment can foster bone loss. Scientists explain how loss of bone mass might affect 46,000 people diagnosed with breast and prostate cancer each year and place them at increased risk for osteoporosis and fractures. ... > read full article

FDA Issues Alert on Bone Drugs
By Elizabeth Trotta
The FDA posted an alert on Monday regarding possible severe, sometimes incapacitating bone, joint, and/or muscle pain in patients taking a class of bone-density drugs called bisphosphonates.
The possibility of such pain is listed in the drugs' prescribing information, but the FDA warned that doctors may overlook it to the point that it's prolonged or results in impairment, possibly requiring analgesics. This pain can occur days, months or years after initial use, and the risk factors for and incidence of severe musculoskeletal pain associated with the class are still unknown, according to the agency.

"Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug," noted the health regulator in a Med Watch post on Monday.

The class of bone drugs in question include:

Proctor & Gamble's(PG Quote - Cramer on PG - Stock Picks) Actonel, Actonel +Ca, and Didronel

Novartis'(NVS Quote - Cramer on NVS - Stock Picks) Aredia, Reclast and Zometa

Roche and GlaxoSmithKline's(GSK Quote - Cramer on GSK - Stock Picks) Boniva

Merck's(MRK Quote - Cramer on MRK - Stock Picks) Foxamax, Fosamax + D

Sanofi Aventis'(SNY Quote - Cramer on SNY - Stock Picks) Skelid.

Drug companies downplay risks of bone-strengthening drugs for women
18.01.2008 Source: URL: -0

Drug companies exaggerate the benefits and downplay the risks of prescribing bone-strengthening drugs for women whose bones are weakened but who do not have osteoporosis, a new report claims.

Drugs such as alendronate and risedronate do reduce the risk of fractures of women with osteoporosis, according to the article in the Jan. 19 issue of BMJ.

Alendronate is a bisphosphonate drug used for osteoporosis and several other bone diseases. It is marketed alone as well as in combination with vitamin D (2,800 U and 5600 U, under the name Fosamax+D). Merck's U.S. patent on alendronate is set to expire in 2008 and Merck has lost a series of appeals to block a generic version of the drug from being certified by the U.S. Food and Drug Administration.

Risedronate sodium is a bisphosphonate used to strengthen bone, treat or prevent osteoporosis, and treat Paget's disease of bone. It is produced and marketed by Procter & Gamble and Sanofi-Aventis.

In January 2006 P&G and its marketing partner Sanofi-Aventis filed a Lanham Act false claims lawsuit against rival drugmakers Roche and GlaxoSmithKline claiming false advertising about Boniva. The manufacturers of Boniva, a rival bisphosphonate, were accused in the suit of causing a "serious public health risk" through misrepresentation of scientific findings. In a ruling on on September 7 2006 U.S. District Judge Paul A. Crotty rejected P&G's attempted injunction. P&G was criticized for attempting to "preserve its market share by denigrating Boniva". Judge Crotty wrote that "Roche was clearly entitled to respond with its own data, provided that the data was truthfully and accurately presented".

Source: «PRAVDA.Ru».