FDA leaves cancer-causing foot gel on the market

Ever wonder what the Rockville rowdys are up to at tax-payer expense? Maybe it is just pushing harmful drugs through the revolving door, with not regard for your health.

Maybe these folks enjoy a work environment where Big Pharma has a gun at their head and a hand in their wallet.

And, of course, this is not the only example!

There are very effective ways to prevent and heal skin ulcers that many people with diabetes suffer with from time to time. These are natural treatments so it is very unlikely that you will learn about them from mainstream medicine.

You might do better to have a visit with a podiatrist. Here you might learn about a papaya based ointment.

Even the most seemingly innocent drugs can carry fatal side effects. The FDA just announced a study showing that the foot gel Regranex could be causing cancer. And yet, amazingly, Regranex is still on the market!

The prescription foot gel is manufactured by Johnson & Johnson and is often used by diabetics who develop leg and foot ulcers that are difficult to heal.

Apparently, diabetics who'd been prescribed the gel three or more times were at increased risk of death from cancer. With incredible gall, the spokesperson for J&J insisted that Regranex is safe when used as directed. What? This is a topical foot gel—if these people are applying it to the sores on their feet and legs, they ARE using it as directed. Should any foot gel be capable of giving you CANCER!? Does this make sense to you?

Consumers Exploring Homeopathy

What is it they say about back to the future or history repeats itself?

Quite a lot when it comes to homeopathy.

This happens to be my favorite method of care, and really what I devote so much of my time to these days through our educational programs.

I am so convinced that homeopathy IS the medicine of the future that we chose this format- in our Simply4Health line - for the 21st Century version of BioSupplemente, in order to maintain it for perpetuity.

We expect RK BioDrops to arrive soon, as the labels are currently being designed.

NEW YORK—Rising numbers of consumers around the world are turning to homeopathy as an effective system of natural medicine, according to a new report from Global TGI; however, there is still considerable divergence of opinion. According to Global TGI, the highest level of “trust” in homeopathic medicine was in India, at 62 percent, followed by Brazil (58 percent) and Saudi Arabia (53 percent). On the other end of the spectrum, only 15 percent of Britons and 18 percent of Americans said they trust in homeopathy.

According to the market research company, consumers who have faith in homeopathy are more likely to have suffered from chronic or recurrent conditions, the areas where homeopathy is typically used. For example, in the United States, homeopathy supporters are 57 percent more likely than average to suffer from eczema or psoriasis, 29 percent more likely to have asthma, and 22 percent more likely to suffer from allergies or hay fever. <04/24/2008>

Where have these folks been all these years?

I guess I would attribute this latest oversight to health care providers who fail to read the literature about the drugs they prescribe to people for chemo.

Really there is no excuse because if I knew this and warned people of these very risks for a few decades, why is it taking so long foe the oncologists to own up to this grievous error and breach of trust, not overlooking the issue of informed consent...

Study Calls For Action On Heart Risks From Certain Anti-cancer Drugs

Conceptual representation of a constellation of factors that synergize with cardiotoxicity induced by a known cardiotoxic drug and make cardiac events occur at lower than expected cumulative doses of that drug. (Credit: Courtesy of P. Menna, E. Salvatorelli and G. Minotti)

ScienceDaily (Apr. 28, 2008) — Heart damage from certain anti-cancer drugs no longer should be regarded as a rare or relatively unimportant complication, scientists in Italy have concluded in a new overview of research on the cardiotoxicity of anti-cancer drugs. Their review recommends that drug regulatory agencies, physicians, and toxicologists join in a focused research effort to combat the problem.

In the new study, Giorgio Minotti, Pierantonio Menna, and Emanuela Salvatorelli point out that the risk of cardiotoxicity may be higher than previously believed, especially in older patients and those with high blood pressure, coronary artery disease, and other risk factors. Studies of long-term survivors of childhood and adult cancer -- more than 10 million people in the United States alone -- also suggest an increased risk of symptomatic cardiac events.

Their review found that newer, targeted drugs can damage the heart, particularly when combined with old-generation chemotherapeutics. "Toxicologists and regulatory agencies and clinicians should therefore join in collaborative efforts that improve early identification of cardiotoxicity and minimize the risks of cardiac events in patients," the article notes.

The article "Cardiotoxicity of Antitumor Drugs" is scheduled for the May 19 issue of Chemical Research in Toxicology,

Adapted from materials provided by American Chemical Society, via EurekAlert!, a service of AAAS.

American Chemical Society (2008, April 28). Study Calls For Action On Heart Risks From Certain Anti-cancer Drugs. ScienceDaily. Retrieved April 29, 2008, from http://www.sciencedaily.com­ /releases/2008/04/080428091709.htm

and while you consider this concern you might want to learn that your insurance company is up to new tricks, just as the "care centers" seem to be.

Cash Before Chemo:Hospitals Get Tough
Bad Debts Prompt Change in Billing;$45,000 to Come In
By BARBARA MARTINEZ
April 28, 2008; Page A1

LAKE JACKSON, Texas -- When Lisa Kelly learned she had leukemia in late 2006, her doctor advised her to seek urgent care at M.D. Anderson Cancer Center in Houston. But the nonprofit hospital refused to accept Mrs. Kelly's limited insurance. It asked for $105,000 in cash before it would admit her.

Sitting in the hospital's business office, Mrs. Kelly says she told M.D. Anderson's representatives that she had some money to pay for treatment, but couldn't get all the cash they asked for that day. "Are they going to send me home?" she recalls thinking. "Am I going to die?"
A growing trend in the hospital industry means cancer patients like Lisa Kelly are being asked to pay cash upfront before receiving treatment.

Hospitals are adopting a policy to improve their finances: making medical care contingent on upfront payments. Typically, hospitals have billed people after they receive care. But now, pointing to their burgeoning bad-debt and charity-care costs, hospitals are asking patients for money before they get treated.

Hospitals say they have turned to the practice because of a spike in patients who don't pay their bills. Uncompensated care cost the hospital industry $31.2 billion in 2006, up 44% from $21.6 billion in 2000, according to the American Hospital Association.

The bad debt is driven by a larger number of Americans who are uninsured or who don't have enough insurance to cover medical costs if catastrophe strikes. Even among those with adequate insurance, deductibles and co-payments are growing so big that insured patients also have trouble paying hospitals.
FINANCIAL HEALTH

• The Issue: Hospitals are asking patients for payment before receiving treatment.
• The Background: Hospitals say the practice is needed because of an increase in the number of people not paying their bills.
• The Bottom Line: While hospitals provide care to the poor, uninsured and underinsured people are likely to be hardest hit.

Letting bad debt balloon unchecked would threaten hospitals' finances and their ability to provide care, says Richard Umbdenstock, president of the American Hospital Association. Hospitals would rather discuss costs with patients upfront, he says. "After, when it's an ugly surprise or becomes contentious, it doesn't work for anybody."

M.D. Anderson says it went to a new upfront-collection system for initial visits in 2005 after its unpaid patient bills jumped by $18 million to $52 million that year. The hospital said its increasing bad-debt load threatened its mission to cure cancer, a goal on which it spends hundreds of millions of dollars a year.

The change had the desired effect: The hospital's bad debt fell to $33 million the following year.
[Lisa Kelly]

Asking patients to pay after they've received treatment is "like asking someone to pay for the car after they've driven off the lot," says John Tietjen, vice president for patient financial services at M.D. Anderson. "The time that the patient is most receptive is before the care is delivered."

M.D. Anderson says it provides assistance or free care to poor patients who can't afford treatment. It says it acted appropriately in Mrs. Kelly's case because she wasn't indigent, but underinsured. The hospital says it wouldn't accept her insurance because the payout, a maximum of $37,000 a year, would be less than 30% of the estimated costs of her care.

Tenet Healthcare and HCA, two big, for-profit hospital chains, say they have also been asking patients for upfront payments before admitting them. While the practice has received little notice, some patient advocates and health-care experts find it harder to justify at nonprofit hospitals, given their benevolent mission and improving financial fortunes.

In the Black

An Ohio State University study found net income per bed nearly tripled at nonprofit hospitals to $146,273 in 2005 from $50,669 in 2000. According to the American Hospital Directory, 77% of nonprofit hospitals are in the black, compared with 61% of for-profit hospitals. Nonprofit hospitals are exempt from taxes and are supposed to channel the income they generate back into their operations. Many have used their growing surpluses to reward their executives with rich pay packages, build new wings and accumulate large cash reserves.

M.D. Anderson, which is part of the University of Texas, is a nonprofit institution exempt from taxes. In 2007, it recorded net income of $310 million, bringing its cash, investments and endowment to nearly $1.9 billion.
[chart]

"When you have that much money in the till and that much profit, it's kind of hard to say no" to sick patients by asking for money upfront, says Uwe Reinhardt, a health-care economist at Princeton University, who thinks all hospitals should pay taxes. Nonprofit organizations "shouldn't behave this way," he says.

It isn't clear how many of the nation's 2,033 nonprofit hospitals require upfront payments. A voluntary 2006 survey by the Internal Revenue Service found 14% of 481 nonprofit hospitals required patients to pay or make an arrangement to pay before being admitted. It was the first time the agency asked that question.

Nataline Sarkisyan, a 17-year-old cancer patient who died in December waiting for a liver transplant, drew national attention when former presidential candidate John Edwards lambasted her health insurer for refusing to pay for the operation. But what went largely unnoticed is that Ms. Sarkisyan's hospital, UCLA Medical Center, a nonprofit hospital that is part of the University of California system, refused to do the procedure after the insurance denial unless the family paid it $75,000 upfront, according to the family's lawyer, Tamar Arminak.

The family got that money together, but then the hospital demanded $300,000 to cover costs of caring for Nataline after surgery, Ms. Arminak says.

UCLA says it can't comment on the case because the family hasn't given its consent. A spokeswoman says UCLA doesn't have a specific policy regarding upfront payments, but works with patients on a case-by-case basis.

Federal law requires hospitals to treat emergencies, such as heart attacks or injuries from accidents. But the law doesn't cover conditions that aren't immediately life-threatening.

At the American Cancer Society, which runs call centers to help patients navigate financial problems, more people are saying they're being asked for large upfront payments by hospitals that they can't afford. "My greatest concern is that there are substantial numbers of people who need cancer care" who don't get it, "usually for financial reasons," says Otis Brawley, chief medical officer.

Mrs. Kelly's ordeal began in 2006, when she started bruising easily and was often tired. Her husband, Sam, nagged her to see a doctor.

A specialist in Lake Jackson, a town 50 miles from Houston, diagnosed Mrs. Kelly with acute leukemia, a cancer of the blood that can quickly turn fatal. The small cancer center in Lake Jackson refers acute leukemia patients to M.D. Anderson.

When Mrs. Kelly called M.D. Anderson to make an appointment, the hospital told her it wouldn't accept her insurance, a type called limited-benefit.

"When an insurer is going to pay the small amounts, we don't feel financially able to assume the risk," says M.D. Anderson's Mr. Tietjen.

An estimated one million Americans have limited-benefit plans. Usually less expensive than traditional plans, such insurance is popular among people like Mrs. Kelly who don't have health insurance through an employer.

Mrs. Kelly, 52, signed up for AARP's Medical Advantage plan, underwritten by UnitedHealth Group Inc., three years ago after she quit her job as a school-bus driver to help care for her mother. Her husband was retired after a career as a heavy-equipment operator. She says that at the time, she hardly ever went to the doctor. "I just thought I needed some kind of insurance policy because you never know what's going to happen," says Mrs. Kelly. She paid premiums of $185 a month.

A spokeswoman for UnitedHealth, one of the country's largest marketers of limited-benefit plans, says the plan is "meant to be a bridge or a gap filler." She says UnitedHealth has reimbursed Mrs. Kelly $38,478.36 for her medical costs. Because the hospital wouldn't accept her insurance, Mrs. Kelly paid bills herself, and submitted them to her insurer to get reimbursed.
[health costs]
See documents related to Mrs. Kelly's case.
• Mrs. Kelly's certificate of coverage1 through the AARP.
• Mrs. Kelly's May 2007 bill2 from M.D. Anderson.
• One of the letters Ms. Wallack sent3 on behalf of Mrs. Kelly, questioning some of M.D. Anderson's charges
• The hospital's response4
• Letter from M.D. Anderson5 to Mrs. Kelly, regarding a refund for a misbilled item
• Collection notice6 sent to Mrs. Kelly
• Letter from M.D. Anderson7 offering a 10% discount for paying the balance in full by April 30.

M.D. Anderson viewed Mrs. Kelly as uninsured and told her she could get an appointment only if she brought a certified check for $45,000. The Kellys live comfortably, but didn't have that kind of cash on hand. They own an apartment building and a rental house that generate about $11,000 a month before taxes and maintenance costs. They also earn interest income of about $35,000 a year from two retirement accounts funded by inheritances left by Mrs. Kelly's mother and Mr. Kelly's father.

Mr. Kelly arranged to borrow the money from his father's trust, which was in probate proceedings. Mrs. Kelly says she told the hospital she had money for treatment, but didn't realize how high her medical costs would get.

The Kellys arrived at M.D. Anderson with a check for $45,000 on Dec. 6, 2006. After having blood drawn and a bone-marrow biopsy, the hospital oncologist wanted to admit Mrs. Kelly right away.

But the hospital demanded an additional $60,000 on the spot. It told her the $45,000 had paid for the lab tests, and it needed the additional cash as a down payment for her actual treatment.

In the hospital business office, Mrs. Kelly says she was crying, exhausted and confused.

The hospital eventually lowered its demand to $30,000. Mr. Kelly lost his cool. "What part don't you understand?" he recalls saying. "We don't have any more money today. Are you going to admit her or not?" The hospital says it was trying to work with Mrs. Kelly, to find an amount she could pay.

Mrs. Kelly was granted an "override" and admitted at 7 p.m.

Appointment 'Blocked'

After eight days, she emerged from the hospital. Chemotherapy would continue for more than a year, as would requests for upfront payments. At times, she arrived at the hospital and learned her appointment was "blocked." That meant she needed to go to the business office first and make a payment.
[photo]
Lisa Kelly

One day, Mrs. Kelly says, nurses wouldn't change the chemotherapy bag in her pump until her husband made a new payment. She says she sat for an hour hooked up to a pump that beeped that it was out of medicine, until he returned with proof of payment.

A hospital spokesperson says "it is very difficult to imagine that a nursing staff would allow a patient to sit with a beeping pump until a receipt is presented." The hospital regrets if patients are inconvenienced by blocked appointments, she says, but it "is a necessary process to keep patients informed of their mounting bills and to continue dialog about financial obligations." She says appointments aren't blocked for patients who require urgent care.

Once, Mrs. Kelly says she was on an exam table awaiting her doctor, when he walked in with a representative from the business office. After arguing about money, she says the representative suggested moving her to another facility.

But the cancer center in Lake Jackson wouldn't take her back because it didn't have a blood bank or an infectious-disease specialist. "It risks a person's life by doing that [type of chemotherapy] at a small institution," says Emerardo Falcon Jr., of the Brazosport Cancer Center in Lake Jackson.

Ron Walters, an M.D. Anderson physician who gets involved in financial decisions about patients, says Mrs. Kelly's subsequent chemotherapy could have been handled locally. He says he is sorry if she was offended that the payment representative accompanied the doctor into the exam room, but it was an example of "a coordinated teamwork approach."

On TV one night, Mrs. Kelly saw a news segment about people who try to get patients' bills reduced. She contacted Holly Wallack, who is part of a group that works on contingency to reduce patients' bills; she keeps one-third of what she saves clients.

Ms. Wallack began firing off complaints to M.D. Anderson. She said Mrs. Kelly had been billed more than $360 for blood tests that most insurers pay $20 or less for, and up to $120 for saline pouches that cost less than $2 at retail.

On one bill, Mrs. Kelly was charged $20 for a pair of latex gloves. On another itemized bill, Ms. Wallack found this: CTH SIL 2M 7FX 25CM CLAMP A4356, for $314. It turned out to be a penis clamp, used to control incontinence.

M.D. Anderson's prices are reasonable compared with other hospitals, Mr. Tietjen says. The $20 price for the latex gloves, for example, takes into account the costs of acquiring and storing gloves, ones that are ripped and not used and ones used for patients who don't pay at all, he says. The charge for the penis clamp was a "clerical error" he says; a different type of catheter was used, but the hospital waived the charge. The hospital didn't reduce or waive other charges on Mrs. Kelly's bills.

Continuing Treatment

Mrs. Kelly is continuing her treatment at M.D. Anderson. In February, a new, more comprehensive insurance plan from Blue Cross Blue Shield that she has switched to started paying most of her new M.D. Anderson bills. But she is still personally responsible for $145,155.65 in bills incurred before February. She is paying $2,000 a month toward those. Last week, she learned that after being in remission for more than a year, her leukemia has returned.

M.D. Anderson is giving Blue Cross Blue Shield a 25% discount on the new bills. This month, the hospital offered Mrs. Kelly a 10% discount on her balance, but only if she pays $130,640.08 by this Wednesday, April 30. She is still hoping to get a bigger discount, though numerous requests have been denied. The hospital says it gives commercial insurers a bigger discount because they bring volume and they are less risky than people who pay on their own.

The hospital has urged Mrs. Kelly to sell assets. But she worries about losing her family's income and retirement savings. Mrs. Kelly says she wants to pay, but, suspicious of the charges she's seen, she says, "I want to pay what's fair."

Write to Barbara Martinez at Barbara.Martinez@wsj.com8
http://online.wsj.com/article/SB120934207044648511.html

Diagnostic Downfalls

I am always working on improving the process I use that helps identify nutritional weaknesses in body systems in order to help people understand what they can do to reverse their health concerns. My increased efforts of late seem to be focused on a planned patent application in the future.

I arrived at this point because for years now I have met with people who have been to doctors and medical naturopaths (the hybrids) and have come away with less than happy results.

Many of the complaints are a lack of diagnosis, an incorrect diagnosis, or no improvement in their health after spending a lot of money. Often, and maybe I should say 'always', I find that the person knows little or nothing about the drugs or treatments prescribed.

And herein lies the reason I provide the kind of service I do. It is called education.

Seemingly that education helps because as a result of it people gain tools to better maneuver in the health care mess we have in the US today.

Will You Be Misdiagnosed? How Diagnostic Errors Happen

ScienceDaily (Apr. 29, 2008) — How frequently do doctors misdiagnose patients? While research has demonstrated that the great majority of medical diagnoses are correct, the answer is probably higher than patients expect and certainly higher than doctors realize. In a Supplement to the May issue of The American Journal of Medicine, a collection of articles and commentaries sheds light on the causes underlying misdiagnoses and demonstrates a nontrivial rate of diagnostic error that ranges from <5% in the perceptual specialties (pathology, radiology, dermatology) up to 10% to 15% in many other fields.

The sensitive issue of diagnostic error is rarely discussed and has been understudied. The papers in this volume confirm the extent of diagnostic errors and suggest improvement will best come by developing systems to provide physicians with better feedback on their own errors.

Guest Editors Mark L. Graber, MD, FACP (Veterans Affairs Medical Center, Northport, NY and Department of Medicine, SUNY Stony Book) and Eta S. Berner, EdD (School of Health Professions, University of Alabama at Birmingham) oversaw the development and compilation of these papers. Drs. Berner and Graber conducted an extensive literature review concerning teaching, learning, reasoning and decision making as they relate to diagnostic error and overconfidence and developed a framework for strategies to address the problem.

They write, "Given that physicians overall are highly dedicated and well-intentioned, we believe that if they were more aware of these factors and their own predisposition to error, they would adopt behaviors and attitudes that would help decrease the likelihood of diagnostic error. ...Being confident even when in error is an inherent human trait, and physicians are no exception. The fact that most of their diagnoses are correct, and that effective feedback regarding their errors is lacking, reinforces this inclination. When directly questioned, many clinicians find it inconceivable that their own error rate could be as high as the literature demonstrates. They acknowledge that diagnostic error exists, but believe the rate is very low, and that any errors are made by others who are less skillful or less careful. This reflects both overconfidence and complacency. ...In medicine, the challenge is to reduce the complacency and overconfidence that leads to failure to recognize when one's diagnosis is incorrect."

Dr. Pat Croskerry and Dr. Geoff Norman review two modes of clinical reasoning to understand the processes underlying overconfidence. Ms. Beth Crandall and Dr. Robert L. Wears highlight gaps in knowledge about the nature of diagnostic problems, emphasizing the limitations of applying static models to the messy world of clinical practice.

In any endeavor, "Learning and feedback are inseparable," according to Dr. Gordon L. Schiff, who discusses the numerous barriers to adequate feedback and follow-up in the real world of clinical practice. Taking another approach, Dr. Jenny W. Rudolph and Dr. J. Bradley Morrison provide an expanded model of the fundamental feedback processes involved in diagnostic problem solving, highlighting particular leverage points for avoiding error. In the final commentary, Dr. Graber identifies stakeholders interested in medical diagnosis and provides recommendations to help each reduce diagnostic error.

These papers also emphasize a second theme. Medical practitioners really do not use systems designed to aid their diagnostic decision making. From early systems in the 1980s to more recent efforts, physicians have underutilized decision-support systems and misdiagnosis rates remain high.

Donald A.B. Lindberg, MD, Director of the National Library of Medicine, writes in an introduction to the Supplement, "I sympathize with and respectfully salute these present efforts to study diagnostic decision making and to remedy its weaknesses...I applaud especially the suggestions to systematize the incorporation of the 'downstream' experiences and participation of the patients in all efforts to improve the diagnostic process."

"In my view, diagnostic error will be reduced only if physicians have a more realistic understanding of the amount of diagnostic errors they personally make," summarizes Paul Mongerson, who created a foundation to promote computer-based and other strategies to reduce diagnostic errors. "I believe that the accuracy of diagnosis can be best improved by informing physicians of the extent of their own (not others) errors and urging them to personally take steps to reduce their own errors."

The Supplement appears in The American Journal of Medicine, Volume 121, Issue 5A (May 2008) published by Elsevier. This supplement was sponsored by the Paul Mongerson Foundation through the Raymond James Charitable Endowment Fund. Many of the ideas expressed here emerged from discussions at a meeting among the authors in Naples, Florida, in December 2006 that was sponsored by the University of Alabama at Birmingham with support from the Paul Mongerson Foundation.

Adapted from materials provided by Elsevier Health Sciences, via EurekAlert!, a service of AAAS.

Elsevier Health Sciences (2008, April 29). Will You Be Misdiagnosed? How Diagnostic Errors Happen. ScienceDaily. Retrieved April 29, 2008, from http://www.sciencedaily.com­ /releases/2008/04/080428092956.htm

Big Pharma Player gets NO from FDA on Proposed Drug

Merck is told NO on it's application for the experimental drug MK-0524A. Another government agency also gave a NO on Merck's proposed trade name for the product, Cordaptive. Merck says it will continue to press on to get the drug approved and file for a different trade name.

Now this is two strikes. The third strike already exists but is ignored by Big Pharma because it clings tightly to the cash cow category of unnecessary cholesterol lowering drugs.

Cholesterol lowering is a category designed to allow for the sale of these drugs, many taken off the market because of deaths, and disliked by patients because of the untoward side effects.

Ultimately, the drugs do little to protect your health, lead to cancer, Alzheimer's, liver failure, kidney failure, muscle wasting, cardiovascular problems and numerous other side effects.

What seems so strange is that this proposed drug contains niacin, or vitamin B3, known to reduce cholesterol. Some people do not like the 'flushing' side effect of B3, but this is a way to let you know the vitamin is working. Niacinamide is non-flushing B3, but it take a longer time to be effective.

Some say the flushing can be counteracted with an aspirin, but I would not encourage increasing the use of aspirin because it has other problems. And besides, why mask the positive effects of B3.

The compound Merck wants to combine with B3, to "offset the side effects of niacin", is laropiprant.

Searching around for information about laropiprant I came up with its chemistry on the AMA web site.

It is interesting to note that lapopriant uses a THERAPEUTIC CLAIM of treating atherosclerosis, dyslipidemia, and related conditions when administered with niacin. And I can't seem to find what it does alone.

But the kicker here is its another fluoride compound with the following chemical names -

1. Cyclopent[b]indole-3-acetic acid, 4-[(4-chlorophenyl)methyl]-7-fluoro-1,2,3,4-tetrahydro-5-(methylsulfonyl)-, (3R)-
2. (-)-[(3R)-4-(4-chlorobenzyl)-7-fluoro-5-(methylsulfonyl)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl]acetic acid.

Remember Baychol? That was a fluoride based anti-cholesterol drug removed from the market.

And look at the problems with fluoride based drugs in other categories like antibiotics, antidepressants and osteoporosis drugs.

Why would you want another round?

But Merck has other ideas.

"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter Kim, president of Merck Research Laboratories.

"We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol," he said in a statement.

"We are encouraged that on April 24, the Committee for Medicinal Products for Human Use (CHMP) recommended marketing approval for MK-0524A in Europe, and we will continue to pursue approval within individual markets in the EU and around the world."

Perhaps you might want to have other plans too, and one should be to stay away from this and other cholesterol lowering drugs.

Improving Hospital Health

For a very long time I have been monitoring the problem with hospital and community induced super infection, what most people refer to as MRSA.

I proposed a natural treatment option, but because it is not drug based it has attracted little attention, except by those who needed help, used my options, and recovered.

As I see it, the bickering still continues about "what to do". It is, I guess, like the Little Red Hen, and 'NO', the sky is 'NOT' falling.

Here is something I find amazing. A hospital takes a novel approach to reducing those testy nocosomial infection rates, and seem to do it well. Where are all the others in this?

I also have to admit chuckling a little bit because some years back the FDA attack me and my web site for material I posted about the history of the use of silver in medicine. Even though silver is common in burn therapy, the FDA still likens it to quackery. Maybe this is my pay back!

http://www.sciencedaily.com/videos/2005/0910-killing_germs.htm

Killing Germs
In Hospitals, Air Ducts with Silver-Based Coating Stay Germ-Free
September 1, 2005 — Preventing hospital infections -- from such stubborn bugs as Staphylococcus aureus -- could get a little easier with a new non-toxic, silver-based material. Used in coating, it helps keep hospital air ducts bacterium- and fungus-free. The material is also used in a number of products including athletic footwear, door hardware, pens and business supplies.

DUARTE, Calif.--For more than 6,000 years, humans have used silver to fight germs, also known as microbes. Now, some hospitals are using a silver compound to reduce hospital infections.

You can't see them, but millions of microorganisms are living quietly among us, in places where we least expect them.

Cancer patient Steve Measer worries about germs a lot. "In the last two months I have been in three separate hospitals." But at the Helford Clinical Research Hospital at City of Hope in Duarte, Calif., where he is receiving treatment, microbes are hard to find.

Dr. James Miser, Chief Executive Officer at City of Hope National Medical Center, says, "The room which we are currently standing is as free of germs as medically possible in a hospital."

This is possible because the ducts delivering air to patients' rooms are coated with a silver-based anti-microbial compound called AgION. It can kill bacteria, viruses and fungus. Jeffrey Trogolo, Chief Technology Officer at AgION Technologies, Inc. in Wakefield, Mass., says, "When the conditions are right, it turns on, and that's where the silver comes out."

Agion technologies is using silver, a centuries-old germ killer, in a unique compound to coat surfaces and instruments that could spread disease. When bacteria are detected, the compound releases silver ions to the surface, killing existing microbes and any new ones that come along. "We have virtually no organisms grown," Dr. Miser says.

It's potent enough to kill germs, but is safe to use on virtually any surface. Trogolo says, "It's less toxic than table salt and less irritating than talcum powder. Ultimately we hope this will result in less infections and actually better outcomes for the patients."

The silver compound can also kill germs in your kitchen, on shopping cart handles, even in your sneakers. It's already used in a number of products including athletic footwear, door hardware, pens and business supplies.
--------------------------------------------------------------------------------
BACKGROUND: Concern over infections acquired in hospitals has intensified over the last several months. AgION Technologies has developed a safe, long-lasting antimicrobial compound based on silver. Researchers have found it to be effective in fighting a wide variety of germs and other pathogens commonly found in healthcare environments. The Clinical Research Hospital at City of Hope in Duarte, Calif., is one of the first in the nation to use AgION-coated antimicrobial steel to minimize infection risks.

HOW IT WORKS: Silver has natural germicidal properties and is one of the oldest antimicrobial agents known. Humans have used silver to ward off disease since the ancient Egyptians; the Greeks used silver vessels for water to keep it fresh. It is still used by settlers in the Australian outback, who suspend silverware in their water tanks to keep spoilage at bay. Silver fell out of favor with the discovery of antibiotics, but interest in its germ-fighting properties has resurged with the rise of drug-resistant organisms and concern over possible epidemics that don't respond to conventional treatment.

RISK FACTORS: Silver is harmless if ingested in small amounts, but like most metals, large doses can be toxic, sometimes fatal. Among other effects, excess silver can be deposited in the skin and tissues, causing discoloration.

The American Society for Microbiology contributed to the information contained in the TV portion of this report.

Note: This story and accompanying video were originally produced for the American Institute of Physics series Discoveries and Breakthroughs in Science by Ivanhoe Broadcast News and are protected by copyright law. All rights reserved.

Just Say YES to Vitamins

So you are one of those millions taking expensive drugs or you are in the next 'cash-cow' wave of Baby Boomers targeted by the pharmaceutical industry to be put on the drug wagon.

You, like many people taking Rx drugs I hear from daily, complain about how you feel and you don't like it.

So what's a body to do about it?

Here is a short list of vitamin deficiencies created by commonly prescribed drugs. Reading this over you just might find a reason to look to supplements.

We are here to help you and are able to offer our drug review service that includes recommendations based on our 50+ years of expertise in the natural health arena. You will also enjoy our selection of very high grade supplements at affordable cost.
Just contact us for more information.

"A healthy diet that provides sufficient amounts of vitamins and minerals is essential to good health, but many studies have shown that numerous common medications can drain vital nutrients from your body. A lack of proper nutrients can contribute to the development of many diseases including cardiovascular disease and cancer.

For example, birth control pills are known to drain vitamins C, B6, B12, folate, riboflavin, selenium and the amino acid tyrosine. And low vitamin C levels are associated with a dramatically increased risk of cervical cancer. Birth control pills also sap magnesium, and women taking these over many years are not only more prone to developing cancer, but they are at greater risk during subsequent surgery and chemotherapy.

Low folate (folic acid) levels have been linked to a variety of cancers, especially those of the breast, cervix and colon. New studies have consistently shown that folate powerfully prevents colon cancer and may slow the growth of other existing cancers.

At least one type of diabetes medication (biguanides) significantly exhausts folate. And aspirin, as well as other over-the-counter pain medications such as ibuprofen, greatly lower folate levels.

A number of medications used to treat high blood pressure are known to reduce levels of such vital nutrients as vitamins B1, K and B6, ascorbate, as well as magnesium, zinc, calcium and CoQ10. In particular, the body’s supply of CoQ10, a critical anticancer nutrient, is siphoned off through use of hypertensive and antidiabetic medications, statins (cholesterol-lowering drugs) and certain antidepressants (phenothiazines and tricyclics).

Statin drugs are notorious when it comes to robbing the body of nutrients. Studies show that they pilfer vitamins A, B12, D, E and K, beta-carotene and folate, as well as calcium, zinc, phosphorus and magnesium.

Magnesium depletion is especially associated with the use of certain chemotherapy drugs, such as cisplatin. In fact, levels can fall so low that the result is heart damage and brain injury.

If you have been taking vitamin-depleting medications for years, you are at great risk, and most doctors are either unaware of the problems or simply choose to ignore the danger."

And how about these comments -

Dozens of factors can cause memory loss like that associated with Alzheimer’s disease. Another one that’s currently overlooked is the use of the highly popular statin drugs. One of my first recommendations would be to avoid the use of all drugs if possible. And for any that you decide to take, make sure you know the stated side effects and keep an eye out for those such as dementia and other neurological problems.

The public is constantly being prescribed drugs without being informed of the ultimate consequences. I have serious doubts that “preventive” drug treatment prolongs life; instead, I think it just changes the cause of death. Examples could fill a book.

One example is the anti-cholesterol statin drugs. Two large drug trials come to mind. One trial known as CARE (Cholesterol And Recurrent Events) found that the drug Pravachol reduced the risk of a heart attack by 24 percent. It also found that it increased the risk of women developing breast cancer by 1,100 percent.

The PROSPER trial followed 5,000 participants, aged 70 to 82 years old, who took a statin for three years. The drugs reduced deaths from cardiovascular disease by a remarkable 24 percent. What wasn’t well publicized, however, was that those on statins developed cancer at a higher rate, and the drug showed no benefits whatsoever in women.

And statins aren’t the only drugs where the patients don’t get the full story. The list is seemingly endless.

One of the most common methods of treating high blood pressure is through use of diuretics or “water pills,” and hydrochlorothiazide is one of ones most frequently used. Studies have consistently shown that these diuretics significantly increase the likelihood of developing diabetes. How many doctors tell their patients that?

Natural Health Care has Validation

In the states it often happens that when something good is available to the people, either some would-be elitist tries to establish a monopoly or the concepts are attacked.

I suggest this is something likened to the on-going attack on supplements proffered by the FDA in conspiracy with the AMA and Big Pharma.

It is also very much like the establishment of restricted access to traditional care by four schools of the new hybrid form of naturopathy, coined "naturopathic medicine".

The schools also seem to want to control who practices using herbs, flower essences, aromatherapy and other related modalities.

Of course the end result is less access to care, more control over what kind of care is offered and higher costs to users.

Idaho is one state where the right of choice and access to care is protected, at least for now. A number of other states do not have legislation limiting care to those who have finished up a degree at the four pro ND licensing schools (some with primary hope to get third-party insurance reimbursement and pay down school loans).

It seems the attack has started in the UK.

As an activist, I would encourage readers to speak out loudly to prevent any further damage -

Alternative medical degrees 'harm' universities
By Tom Peterkin
Last Updated: 2:43am BST 24/04/2008

A growing number of universities are offering "bogus" degrees in alternative and complementary medicine, researchers warn today.

Greenwich offers five BSc degrees including aromatherapy

The increasing number of courses in subjects such as homeopathy, acupuncture and Chinese medicine is "besmirching the reputation" of the country's higher education system, they say.

A top five list of institutions offering "unscientific" degrees has been compiled to highlight the extent to which alternative medicine is being taught in universities.

The rankings, which are topped by Westminster University, have been drawn up to provoke vice-chancellors into debating the scientific basis for such degrees.

"We want to embarrass them into acknowledging the pseudo-scientific degrees they are offering," said the authors of the survey, which is published in the Times Higher Education magazine.

advertisementWestminster University offers five BSc honours degrees, which cover Chinese medicine and acupuncture, complementary therapies, homoeopathy, naturopathy plus remedial massage and neuromuscular therapy.

An MSc in Chinese herbal medicine is also available.

Students at Middlesex can choose from three BSc (Hons) courses in complementary health sciences and Chinese medicine, plus two MSc degrees in Ayurvedic medicine, native to the Indian subcontinent, and Chinese medicine.

Greenwich offers five BSc degrees including aromatherapy and complementary stress management therapies. Counselling, Chinese medicine, homoeopathy and acupuncture are on offer in Salford University's four BSc complementary medicine degrees.

At Thames Valley University, students can study for a BSc (Hons) in homoeopathy or complementary medicine in healthcare or an MA in Naad yoga.

The table was drawn up by Edzard Ernst, a professor of complementary medicine at Exeter University, and Simon Singh, a science author.

They went through the Universities and Colleges Admissions Service and university websites and found 43 institutions offering a total of 155 "unscientific" courses.

Westminster University said its courses included research and criticism. Middlesex University said Indians and Sri Lankans had considered Ayurveda a science for thousands of years.

Tim Duerden, a complementary medicine lecturer at Salford, said students were given the chance to develop their critical faculties.

Greenwich said the survey had wrongly listed three different courses, which were in fact three different strands of the same degree. Two others had been withdrawn.

Thames Valley said the yoga course was not part of its science department.

http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2008/04/24/nuni124.xml

Peppermint takes on a Medical Mask

Peppermint Oil May Relieve Digestive Symptoms, Headaches

Authors and Disclosures
Laurie Barclay, MD, has disclosed no relevant financial relationships.
Charles P. Vega, MD, FAAFP, has disclosed that he has received grants for educational activities from Pfizer.

April 13, 2007 — Peppermint oil is effective in treating digestive disorders and other conditions including headaches, although high dosages may cause adverse effects, according to the results of a review reported in the April 1 issue of American Family Physician.

"The medicinal use of peppermint and other mint plants probably dates back to the herbal pharmacopoeia of ancient Greece, where peppermint leaf traditionally was used internally as a digestive aid and for management of gallbladder disease; it also was used in inhaled form for upper respiratory symptoms and cough," write Benjamin Kligler, MD, MPH, from the Albert Einstein College of Medicine of Yeshiva University in New York, and Sapna Chaudhary, DO, from the Beth Israel Continuum Center for Health and Healing in New York. "Peppermint oil, which is extracted from the stem, leaves, and flowers of the plant, has become popular as a treatment for a variety of conditions, including irritable bowel syndrome (IBS), headache, and non-ulcer dyspepsia."

Specific applications of note are as follows:

Peppermint leaf and oil have a long history of use for digestive disorders.

Enteric-coated peppermint oil is a safe alternative to effectively reduce some IBS symptoms, recent evidence suggests, although some evidence is conflicting (evidence rating, B).

Peppermint oil combined with caraway oil appears moderately effective in treating nonulcer dyspepsia (evidence rating, B).

Peppermint oil applied topically may effectively treat tension headache (evidence rating, B).

Peppermint oil has relaxant effects on smooth muscle. When given via enema, it has been shown to be modestly effective in relieving colonic spasm in patients undergoing barium enemas (evidence rating, B).

Although peppermint oil is well tolerated at the commonly recommended dosage, it may cause significant adverse effects at higher dosages. Common adverse effects include allergic reactions, heartburn, perianal burning, blurred vision, nausea, and vomiting. Interstitial nephritis and acute renal failure are rare.

Because peppermint oil may inhibit the cytochrome P450 1A2 system, it may interact with drugs metabolized via this system.

Peppermint oil is contraindicated in patients with hiatal hernia, severe gastroesophageal reflux, and gallbladder disorders and should be used with caution in pregnant and lactating women.

The recommended dosage is 0.2 to 0.4 mL of peppermint oil 3 times daily in enteric-coated capsules for adults, and 0.1 to 0.2 mL of peppermint oil 3 times daily for children older than 8 years. Cost is approximately $24 to $32 for a 1-month supply.

"Peppermint oil should not be used internally or on or near the face in infants and young children because of its potential to cause bronchospasm, tongue spasms, and, possibly, respiratory arrest," the authors conclude. "However, the amount of peppermint in over-the-counter medications, topical preparations, and herbal teas is likely safe in pregnant and lactating women and in young children."

The authors have disclosed no relevant financial relationships.

Am Fam Physician. 2007;75:1027-1030.

Clinical Context
Peppermint has been used as a medicinal substance for thousands of years. Most modern preparations of peppermint use its oil, which usually is provided with an enteric coating to prevent gastroesophageal reflux. This oil contains menthol, menthone, cineol, and other oils, and there is evidence that this combination of compounds can relax gastrointestinal smooth muscle as well as lower esophageal sphincter pressure.

Peppermint oil has been used to treat not only gastrointestinal complaints but also headache. The current article reviews the efficacy and safety of peppermint oil for these indications.

Study Highlights
Peppermint oil appears to be mildly effective in reducing symptoms of IBS, particularly flatulence, abdominal pain, and distension, in adults. However, there has been significant heterogeneity among research into this subject.

A study of children between the ages of 8 and 17 years who had IBS found that peppermint oil was more effective than placebo in reducing the severity of abdominal pain.

Two(2)trials have demonstrated that treatment with peppermint oil reduced the risk for gastrointestinal spasm during barium enema, with peppermint associated with up to a 3-fold increase vs placebo in the rate of having a procedure free of spasm.
The combination of 90 mg of peppermint oil plus 50 mg of caraway oil has been demonstrated to reduce symptoms of nonulcer dyspepsia, including fullness, bloating, and spasm. This combination should be used cautiously for patients with dyspepsia, as peppermint oil may promote gastroesophageal reflux.

2 studies have delineated the efficacy of topical peppermint oil in tension headache. In 1 study, a combination of peppermint and ethanol was superior to placebo in terms of analgesia. Another trial demonstrated that topical peppermint oil was similar to acetaminophen in terms of treatment efficacy.

The therapeutic dosage in most trials of peppermint oil and IBS was 0.2 to 0.4 mL taken 3 times daily in enteric-coated capsules. The 1 trial examining its use for childhood IBS used a dosage of 0.1 mL of peppermint oil 3 times daily for children weighing less than 45 kg.

Peppermint oil can be toxic in overdose, leading to interstitial nephritis and acute renal failure. Because it may promote gallstone formation, it should not be used in patients with cholelithiasis or cholecystitis. Peppermint oil also may trigger menstruation and should not be used during pregnancy.

The most common adverse events associated with peppermint oil include allergic reactions, heartburn, perianal burning, blurred vision, nausea, and vomiting. Peppermint oil may inhibit the cytochrome P450 1A2 system.

Pearls for Practice
Peppermint oil contains menthol, menthone, and cineol and may work by relaxing smooth muscle in the gastrointestinal tract. Peppermint oil also may reduce lower esophageal sphincter pressure and therefore usually is supplied with enteric coating.
Peppermint oil offers mild efficacy for symptoms of IBS and may improve colonic spasm associated with barium enema. Topical formulations of peppermint oil may improve tension headache.

PEPPERMINT

TRADITIONAL HERBAL USES
---Medicinal Action and Uses---Peppermint oil is the most extensively used of all the volatile oils, both medicinally and commercially. The characteristic anti-spasmodic action of the volatile oil is more marked in this than in any other oil, and greatly adds to its power of relieving pains arising in the alimentary canal.

From its stimulating, stomachic and carminative properties, it is valuable in certain forms of dyspepsia, being mostly used for flatulence and colic. It may also be employed for other sudden pains and for cramp in the abdomen; wide use is made of Peppermint in cholera and diarrhoea.

It is generally combined with other medicines when its stomachic effects are required, being also employed with purgatives to prevent griping. Oil of Peppermint allays sickness and nausea, and is much used to disguise the taste of unpalatable drugs, as it imparts its aromatic characteristics to whatever prescription it enters into. It is used as an infants' cordial.

The oil itself is often given on sugar and added to pills, also a spirit made from the oil, but the preparation in most general use is Peppermint Water, which is the oil and water distilled together.

Peppermint Water and spirit of Peppermint are official preparations of the British Pharmacopoeia.

In flatulent colic, spirit of Peppermint in hot water is a good household remedy, also the oil given in doses of one or two drops on sugar.

Peppermint is good to assist in raising internal heat and inducing perspiration, although its strength is soon exhausted. In slight colds or early indications of disease, a free use of Peppermint tea will, in most cases, effect a cure, an infusion of 1 ounce of the dried herb to a pint of boiling water being employed, taken in wineglassful doses; sugar and milk may be added if desired.

An infusion of equal quantities of Peppermint herb and Elder flowers (to which either Yarrow or Boneset may be added) will banish a cold or mild attack of influenza within thirty-six hours, and there is no danger of an overdose or any harmful action on the heart. Peppermint tea is used also for palpitation of the heart.

In cases of hysteria and nervous disorders, the usefulness of an infusion of Peppermint has been found to be well augmented by the addition of equal quantities of Wood Betony, its operation being hastened by the addition to the infusion of a few drops of tincture of Caraway.

ESSENTIAL OIL
Botanical Name: Mentha piperita
Common Method of Extraction: Steam Distilled
Color: Clear with a Yellow Tinge
Consistency: Thin
Perfumery Note: Top
Strength of Initial Aroma: Strong

Aromatic Description: Minty, reminiscent of peppermint candies, but more concentrated. More fragrant than spearmint.

Peppermint

Possible Uses: Asthma, colic, exhaustion, fever, flatulence, headache, nausea, scabies, sinusitis, vertigo. [Julia Lawless, The Illustrated Encyclopedia of Essential Oils (Rockport, MA: Element Books, 1995), 59-67.]

Constituents: Menthyl Acetate, Menthone, Cineole, Limonene, Phellandrene, Pinene, Beta-Caryophyllene [Shirley Price, The Aromatherapy Workbook (Hammersmith, London: Thorsons, 1993), 54-5.]

Safety Information: Avoid in cardiac fibrillation, epilepsy, fever. Mucous membrane irritant and neurotoxic (toxic to the nerves). Some of this information applies to oral use, but is provided for informational purposes (no essential oil should be taken internally without the guidance of a qualified aromatherapy practitioner). [Robert Tisserand, Essential Oil Safety (United Kingdom: Churchill Livingstone, 1995), 160.]

May cause sensitization. [Julia Lawless, The Illustrated Encyclopedia of Essential Oils (Rockport, MA: Element Books, 1995), 175.]

Important Note: The information provided in the Oil Profiles area is for educational purposes only. This data is not considered complete and is not guaranteed to be accurate.

General Safety Information: Do not take any oils internally without consultation from a qualified aromatherapy practitioner. Do not apply undiluted essential oils, absolutes, CO2s or other concentrated essences onto the skin. If you are pregnant, epileptic, have liver damage, have cancer, or have any other medical problem, use oils only under the proper guidance of a qualified aromatherapy practitioner. Use extreme caution when using oils with children and give children only the gentlest oils at extremely low doses. It is safest to consult a qualified aromatherapy practitioner before using oils with children. A skin patch test should be conducted prior to using an oil that you've never used before. Instructions on conducting a skin patch test and more safety information can be found by visiting the Safety Information page. For very in-depth information on oil safety issues, read Essential Oil Safety by Robert Tisserand.

Pay offs at FDA: Drug approval and green light for danger

Cash greases the wheels of FDA approvals now more than ever with the new legislation passed in 2007 -----

Another doctor's comments

Ask any doctor, and he'll tell you that speed and safety rarely go hand-in-hand. As a recent study indicates, it's just as true for the drug approval process as it is for a surgical procedure.

Researchers at Harvard detected a disturbing correlation between the drugs that received lightning-fast FDA approvals and the drugs that ultimately needed to be pulled off the market due to safety issues.

Forgive me if I'm not surprised.

Back in 1992, Congress imposed approval deadlines on the FDA – and you'll never believe why. Drug companies agreed to pay millions in fees to the FDA to enable the money-strapped agency to hire more reviewers that would help to clear the gigantic logjam of drug applications. In return for this payment, the FDA agreed to speed the approval (or rejection) of 90 percent of all potential drugs within a year of the application's submission – or they'd have to refund the money. What's more, the FDA has only six months to approve drugs that are considered to be "lifesaving" or otherwise "high priority."

Outrageous? You bet. This is a Federal agency that's charged with the unbiased review of the safety of food and drugs for public consumption… and yet they entered into a lucrative financial arrangement WITH THE VERY COMPANIES WHOSE PRODUCTS THEY ARE INTENTED TO MONITOR.

According to the Harvard study, the FDA is 3.4 times more likely to approve a drug in the two months leading up to a deadline. Like any government agency, the FDA doesn't want to be in the business of giving money back, so it's finally spurred into action once a possible refund is hanging over its head.

Dr. Steven Nissen, chief of cardiology at the Cleveland Clinic, was among the first to raise concerns about drugs like Vioxx, Bextra, Rezuilin, and Baycol – all of which were approved just in time to meet their approval deadline, but were all ultimately pulled off the market. Nissen called the Harvard study a "wake-up call," adding that it "puts the FDA in a very difficult situation when they're trying to make complex decisions under these very, very tight deadlines; we've got to reevaluate now whether that's good public policy."

I can save the reevaluation time: it's horrific public policy. And it's a blatant conflict of interest for the FDA. Approve the drugs fast or lose the cash!? It's the worst possible example of my tried and true dictum to "follow the money."

Of course, the FDA's policy with this – as with everything else – is deny, deny, deny. FDA drug chief Dr. Janet Woodcock said, "The FDA won't approve a drug if we are not ready. And we have the option of denying approval altogether if there is any question about safety."

Thanks for the info, Dr. Woodcock – we all know that the FDA "has the option" to deny approval. That's the whole point of having an approval process in the first place. The question is whether or not the agency is exercising that option judiciously (or at all), and for the right reasons. The fact that she even phrases it as "having the option" gives me chills.

Unfortunately, I'm not sure that this raised alarm will ultimately do any good. As the economy slackens, federal budgets dwindle. Those processing fees paid by the deep- pocketed Big Pharma companies are not likely to be supplanted by tax money or reallocation any time in the near future. And last year, Congress reaffirmed the deadline system, so it's unlikely to make it back into any serious floor debate any time soon.

Besides … there's money to be made. And as always, the public good will take a back seat to the almighty dollar.

Fast to point out too-fast FDA approvals,

William Campbell Douglass II, M.D.

Drug company buy outs in the supplement industry continue

Pharmaceuticals industry

GSK pays $720m for elixir of life
Graeme Wearden guardian.co.uk, Wednesday April 23 2008

This article was first published on guardian.co.uk on Wednesday April 23 2008. It was last updated at 11:58 on April 23 2008.

The drug maker GlaxoSmithKline has bought a US company that uses a molecule found in red wine to try to slow the ageing process.

GSK announced last night that it is paying $720m (£362m) for Sirtris Pharmaceuticals, a small firm based in Cambridge, Massachusetts.

Sirtris is a pioneer in the study of sirtuins, a class of enzymes thought to prevent illnesses such as diabetes and Parkinson's disease, and to inhibit the processes behind ageing and obesity.

GSK is paying $22.50 a share for Sirtris, an 84% premium on its closing share price yesterday. It said the deal could lead to the production of exciting new drugs.

"Modulation of this family of enzymes is a potentially transformative science that could address diseases associated with metabolism and ageing such as diabetes, muscle wasting, and neurodegeneration," said Moncef Slaoui, the chairman of research and development at GSK.

Sirtris's research has focused on resveratrol, a compound found in grapes and red wine. It is known to increase the production of sirtuins by activating a gene called SIRT1.

Sirtris has been developing drugs that act in the same way as resveratrol by triggering the expression of the SIRT1 gene. It has conducted around 20 clinical trials.

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http://www.guardian.co.uk/business/2008/apr/23/glaxo.sirtris/print

Chemo continues to damage

Here are two recent reports discussing the damage caused by chemotherapy. What part of this is your doctor NOT telling you?

Chemotherapy Causes Delayed Severe Neural Damage, Study Shows
ScienceDaily (Apr. 22, 2008) — Cancer treatment with chemotherapeutic agents is often associated with delayed adverse neurological consequences - an occurrence often referred to as "chemobrain" - that may compromise the quality of life of a proportion of cancer survivors. Now, new research demonstrates that treatment with a single chemotherapeutic agent, 5-fluorouracil (5-FU), by itself is sufficient to cause a syndrome of delayed degeneration in the central nervous system (CNS). 5-FU is a widely used chemotherapeutic agent that is employed, alone or in combination with other agents, in the treatment of cancers of the colon, rectum, breast, stomach, pancreas, ovaries and bladder.

Little is known about the side-effects of chemotherapy on the CNS, despite their obvious clinical importance. Until now researchers have not fully understood the underlying biology, including whether these effects require: exposure to multiple chemotherapeutic agents; chemotherapeutic agents plus the body's own response to cancer; blood-brain barrier damage; or inflammation. Clinicians have also lacked animal models to study this important problem.

Professor Mark Noble and colleagues of the University of Rochester Stem Cell and Regenerative Medicine Institute and the Harvard Medical School, Boston discovered that short-term systemic administration of 5-FU to mice caused both acute CNS damage and a syndrome of progressively worsening delayed damage. This damage was not self-repairing, and instead became worse over time. In addition, Noble and colleagues also demonstrated that treatment with chemotherapy also had delayed effects on the speed with which information is transferred from the ear to the brain.

Myelin sheaths are necessary for normal neuronal function. One key finding of the study was that clinically relevant concentrations of 5-FU were toxic not only for dividing cells of the CNS but also for the cells that produce the insulating myelin sheaths (non-dividing oligodendrocytes). The delayed damage the researchers measured was to the myelinated tracts of the CNS and associated with extensive myelin pathology. The findings regarding the speed of ear-to-brain information transfer may offer a non-invasive means of analyzing myelin damage associated with cancer treatment.

"Multiple clinical reports have identified neurotoxicity as a complication of treatment regimens in which chemotherapeutic agents such as 5-fluorouracil are components," says Noble. "As treatments with chemotherapeutic agents will clearly remain the standard of care for cancer patients for many years to come, the need to better understand such damage is great."

Professor Noble continues "These studies extend the field of stem cell medicine beyond the use of cell transplantation for tissue repair. It is our knowledge of stem cell biology that allows us to begin to understand some of the causes of this syndrome, as well as providing the means of preventing or repairing this damage."

This research provides the first demonstration that delayed CNS damage can be induced by a single chemotherapeutic agent and also generates the first animal model of such damage. These studies further demonstrate that this syndrome differs from that caused by irradiation and thus may represent a new class of delayed CNS degenerative damage.

Journal reference: Systemic 5-fluorouracil treatment causes a syndrome of delayed myelin destruction in the CNS. Ruolan Han, Yin M. Yang, Joerg Dietrich, Anne Luebke, Margot Mayer-Pröschel and Mark Noble. Journal of Biology (in press)

Adapted from materials provided by BioMed Central/Journal of Biology, via EurekAlert!, a service of AAAS.

BioMed Central/Journal of Biology (2008, April 22). Chemotherapy Causes Delayed Severe Neural Damage, Study Shows. ScienceDaily. Retrieved April 23, 2008, from http://www.sciencedaily.com­ /releases/2008/04/080421191425.htm

Chemotherapy's Damage To The Brain Detailed

While it is increasingly acknowledged by the scientific community that many chemotherapy agents may have a negative impact on brain function in a subset of cancer patients, the precise mechanisms that underlie this dysfunction have not been identified. (Credit: iStockphoto/Vasiliy Yakobchuk)ScienceDaily (Apr. 22, 2008) — A commonly used chemotherapy drug causes healthy brain cells to die off long after treatment has ended and may be one of the underlying biological causes of the cognitive side effects -- or "chemo brain" -- that many cancer patients experience. That is the conclusion of a study published today in the Journal of Biology.

A team of researchers at the University of Rochester Medical Center (URMC) and Harvard Medical School have linked the widely used chemotherapy drug 5-fluorouracil (5-FU) to a progressing collapse of populations of stem cells and their progeny in the central nervous system.

"This study is the first model of a delayed degeneration syndrome that involves a global disruption of the myelin-forming cells that are essential for normal neuronal function," said Mark Noble, Ph.D., director of the University of Rochester Stem Cell and Regenerative Medicine Institute and senior author of the study. "Because of our growing knowledge of stem cells and their biology, we can now begin to understand and define the molecular mechanisms behind the cognitive difficulties that linger and worsen in a significant number of cancer patients."

Cancer patients have long complained of neurological side effects such as short-term memory loss and, in extreme cases, seizures, vision loss, and even dementia. Until very recently, these cognitive side effects were often dismissed as the byproduct of fatigue, depression, and anxiety related to cancer diagnosis and treatment. Now a growing body of evidence has documented the scope of these conditions, collectively referred to as chemo brain. And while it is increasingly acknowledged by the scientific community that many chemotherapy agents may have a negative impact on brain function in a subset of cancer patients, the precise mechanisms that underlie this dysfunction have not been identified.

Virtually all cancer survivors experience short-term memory loss and difficulty concentrating during and shortly after treatment. A study two years ago by researchers with the James P. Wilmot Cancer Center at the University of Rochester showed that upwards of 82% of breast cancer patients reported that they suffer from some form of cognitive impairment.

While these effects tend to wear off over time, a subset of patients, particularly those who have been administered high doses of chemotherapy, begin to experience these cognitive side effects months or longer after treatment has ceased and the drugs have long since departed their systems. For example, a recent study estimates that somewhere between 15 and 20 percent of the nation's 2.4 million female breast cancer survivors have lingering cognitive problems years after treatment. Another study showed that 50 percent of women had not recovered their previous level of cognitive function one year after treatment.

Two years ago, Noble and his team showed that three common chemotherapy drugs used to treat a wide range of cancers were more toxic to healthy brain cells than the cancer cells they were intended to treat. While these experiments were among the first to establish a biological basis for the acute onset of chemo brain, they did not explain the lingering impact that many patients experience.

The scientists conducted a similar series of experiments in which they exposed both individual cell populations and mice to doses of 5-fluorouracil (5-FU) in amounts comparable to those used in cancer patients. 5-FU is among a class of drugs called antimetabolites that block cell division and has been used in cancer treatment for more than 40 years. The drug, which is often administered in a "cocktail" with other chemotherapy drugs, is currently used to treat breast, ovarian, stomach, colon, pancreatic and other forms of cancer.

The researchers discovered that months after exposure, specific populations of cells in the central nervous -- oligodendrocytes and dividing precursor cells from which they are generated -- underwent such extensive damage that, after 6 months, these cells had all but disappeared in the mice.

Oligodendrocytes play an important role in the central nervous system and are responsible for producing myelin, the fatty substance that, like insulation on electrical wires, coats nerve cells and enables signals between cells to be transmitted rapidly and efficiently. The myelin membranes are constantly being turned over, and without a healthy population of oligodendrocytes, the membranes cannot be renewed and eventually break down, resulting in a disruption of normal impulse transmission between nerve cells.

These findings parallel observations in studies of cancer survivors with cognitive difficulties. MRI scans of these patients' brains revealed a condition similar to leukoencephalopathy. This demyelination -- or the loss of white matter -- can be associated with multiple neurological problems.

"It is clear that, in some patients, chemotherapy appears to trigger a degenerative condition in the central nervous system," said Noble. "Because these treatments will clearly remain the standard of care for many years to come, it is critical that we understand their precise impact on the central nervous system, and then use this knowledge as the basis for discovering means of preventing such side effects."

Noble points out that not all cancer patients experience these cognitive difficulties, and determining why some patients are more vulnerable may be an important step in developing new ways to prevent these side effects. Because of this study, researchers now have a model which, for the first time, allows scientists to begin to examine this condition in a systematic manner.

###
Other investigators participating in the study include Ruolan Han, Ph.D., Yin M. Yang, M.D., Anne Luebke, Ph.D., Margot Mayer-Proschel, Ph.D., all with URMC, and Joerg Dietrich, M.D., Ph.D., formerly with URMC and now with Harvard Medical School. The study was funded by the National Institutes of Neurological Disorders and Stroke, the Komen Foundation for the Cure, and the Wilmot Cancer Center.

Adapted from materials provided by University of Rochester Medical Center.

University of Rochester Medical Center (2008, April 22). Chemotherapy's Damage To The Brain Detailed. ScienceDaily. Retrieved April 23, 2008, from http://www.sciencedaily.com­ /releases/2008/04/080422103947.htm

HIV/AIDS Drugs and Monitoring Scheme

It would seem to me that instead of monitoring drug adherence and effort to look at preventive use of supplements to help with this serious health problem would be more in order.

This concept is something I have addressed on this blog before, and I am happy to take any chance to do the same thing again.

Scientists Test Device To Track Medication Adherence In Patients With HIV/AIDS

ScienceDaily (Apr. 22, 2008) — Most of us have missed a dose of antibiotic or forgotten to take a daily vitamin. But when the stakes are higher -- as they are for people with HIV/AIDS -- a skipped pill could mean the difference between health and hazard for the entire population.

Now, a breath monitoring device developed by scientists at the University of Florida and Xhale Inc. could help prevent the emergence of drug-resistant strains of HIV by monitoring medication adherence in high-risk individuals.

"For HIV, it's been shown that if you don't take a very high percentage of your medication, you may as well not take medication at all," said Richard Melker, M.D., a professor of anesthesiology at the UF College of Medicine and chief technology officer for Xhale.

Patients who take some but not all of their medication increase the likelihood the virus will mutate into a deadlier, drug-resistant form. Experts have tried literally hundreds, if not thousands, of ways to monitor drug adherence, ranging from daily log books to blister packs that record the time each pill is dispensed. Despite the money, time and effort devoted to these methods, Melker said only one works well: directly observed therapy, or DOT.

"If you have a disease that is deemed to be a public health risk, authorities can put you into a program where you have to come to the clinic every day and be observed putting the pill into your mouth and swallowing it," Melker said.

But that process is inconvenient for patients, as well as for clinic personnel who have to track them down when they fail to show up. A breath-monitoring device developed by UF scientists and Xhale could change that, allowing patients to participate in a type of virtual DOT from home.

"The machine sits in your home and when it's time for you to take your medication, it makes a beeping noise. If you don't hit a button after about five minutes, it's going to beep louder and louder until you come," Melker said. "If you don't come after a certain amount of time, the machine can call the clinical trial coordinator and indicate that subject or patient didn't take the medication as prescribed."

The device, which is slightly smaller than a shoebox, records the results of each breath test, allowing patients to bring a memory card or USB key to the clinic once a month and receive a printout of their results. Eventually, the researchers hope to reduce the size of their detection device to fit inside a cell phone. But for now, they're satisfied that the technology works.

"The doctor can see how often you took it and exactly what time. If it made the patient really sick or dizzy and they didn't take it, they can find out why," Melker said. "It's not just a question of did I or didn't I take it, but when you took it or why you didn't take it."

The researchers developed the adherence monitor by incorporating minute amounts of an alcohol into a gel capsule. The additive, called 2-butanol, is one of many GRAS -- Generally Recognized as Safe -- compounds approved by the Food and Drug Administration for use in foods.

"We wanted (patients) to swallow a chemical and have it transform into something else that's easy to monitor," said Matthew Booth, Ph.D., an assistant professor of anesthesiology at the UF College of Medicine and an investigator in the study. "When it hits the stomach lining and liver, an enzyme converts the alcohol to a gas that can be measured in the breath."

To determine how well the byproduct could be detected, six healthy volunteers swallowed empty pills in which the capsules contained trace amounts of 2-butanol. After five to 10 minutes, the scientists could measure the volatile byproduct in the volunteers' breath using a small detector. The scientists say their device could also be used to monitor medication adherence in patients with other communicable diseases, such as tuberculosis.

"It is encouraging that the biological and chemical elements of the adherence system work as predicted. We were able to conclusively show who swallowed the capsules containing the 2-butanol. With further optimization, we are optimistic the device will perform very well," said Donn Dennis, M.D., the Joachim S. Gravenstein professor of anesthesiology at the UF College of Medicine and an investigator in the study.

The researchers say the device may prove equally helpful for monitoring adherence in clinical trials.

"If you enroll HIV/AIDS patients in a clinical trial and they don't take the medication, then you may not get adequate proof that the drug is effective," Melker said. "It might be effective, but some of the patients aren't taking it."

Phase 2 trials are often conducted in the community, rather than at research institutions, making it difficult for researchers to monitor adherence. As a result, many trials enroll a larger group of subjects than needed, in hopes they'll obtain enough data to determine the safety and efficacy of the medication.

"If we had a good way of doing DOT that's realistic, instead of having someone come to your house or you going to clinic every day of your life, then we would know whether these people stopped taking their medication and why. Right now, nobody knows any of that." Melker said. "The implications of being able to understand what normal human behavior is in a clinical trial and, of course, in the real world, are huge."

Adapted from materials provided by University of Florida.

University of Florida (2008, April 22). Scientists Test Device To Track Medication Adherence In Patients With HIV/AIDS. ScienceDaily. Retrieved April 23, 2008, from http://www.sciencedaily.com­ /releases/2008/04/080421121947.htm

Still Covering up the Risks, after all these years

My apologies to Paul Simon for taking off with part of a line from his song, Still Crazy After All These Years, but it seems very appropriate.

I may be called crazy for my positions from time to time but you run that risk when you try to educate people about reality, against the grain of the mass marketing of things that may not really do the job, or cause more harm.

This past weekend I was in Spokane, WA participating in a workshop on various aspects of survival. My section of the program was about natural health care, of course.

While waiting for the program to begin I noticed many women walking in the direction of the new convention center for the women's show, all dressed up in their pink.

I do happen to like certain shades of pink, especially magenta, but I am one not easily swayed by a massive PR campaign that has been operating for too many years, with less than stellar outcomes.

One of the items on the fund raising agenda of the Woman's Show and the Sunday replay of the 'Race for the Cure' was new mammography equipment for Sacred Heart Hospital. I am sure this is an agenda items in most places promoting the 'Race'.

While I am not opposed to raising money for women's health, or other health care concerns, I am opposed to institutionalized campaigns that - in effect - do not achieve the goal as stated.

Ladies, mammogram causes cancer! Why is there no fund raising for Thermography machines that detect earlier, don't promote cancer, and don't force you to compress breast tissue?

Ladies, there is no cure because if one had been found the cash pipeline would disappear.

Ladies, please get educated.

Start here with one of my old fact sheets.

Think Before You Pink –

For well more than a decade I have been teaching women about the facts - and risks - of industrialized medicine. Part of this system is the approach to breast cancer and other supposedly helpful treatments for conditions we are told are risks to our health.

Much of this is far from truth, as is, for instance the information I was given while a college student, that breast cancer would be cured by 1972.

Since this isn't what happened I would like to share some facts for your consideration because mammography offers marginal benefit, the risk is substantial, and the costs incurred are enormous."

“…Mammograms increase the risk for developing breast cancer and raise the risk of spreading or metastasizing an existing growth,' says Dr. Charles B. Simone, a former clinical associate in immunology and pharmacology at the National Cancer Institute...“…the annual mammography screening of 10,000 women aged 50-70 will extend the lives of, at best, 26 of them; and annual screening of 10,000 women in their 40s will extend the lives of only 12 women per year."

In a Swedish study of 60,000 women, 70 percent of tumors detected by mammography weren't tumors at all. These "false positives" aren't just financial and emotional strains, they may also lead to many unnecessary and invasive biopsies. In fact, 70 to 80 percent of all positive mammograms do not, upon biopsy, show any presence of cancer. Remember also that it takes 8 to 12 years for a 'tumor' to be detected by x-ray.

For some reason mammography-centric medicine has completely overlooked the much safer thermal and infrared imaging technologies... Further no comments are made regarding dangers of X-Ray exposure. An allegation that breast screening is being over-promoted to women who are not being alerted to the harm that can result was published in the British Medical Journal several years ago.

Hazel Thornton, a former breast cancer patient and visiting fellow at the University of Leicester, and Michael Baum, emeritus professor of surgery at University College, London, and a long-time critic of screening, have teamed up with a colleague to demand information for women that sets out the risks and benefits. They cite evidence showing 1,200 women would have to be screened for 14 years to save one life from breast cancer while during that time scores would suffer anxiety, surgery and mastectomies for suspicious lumps that turned out to be benign.

In 1978, Irwin J. D. Bross, Director of Biostatistics at Roswell Park Memorial Institute for Cancer Research commented about the cancer screening program: "The women should have been given the information about the hazards of radiation at the same time they were given the sales talk for mammography... A jump to the exposure of a quarter of a million persons to something which could do more harm than good was criminal and it was supported by money from the federal government and the American Cancer Society."

The National Cancer Institute (NCI) was warned in 1974 by Professor Malcolm C. Pike at the University of Southern California, School of Medicine. A number of specialists concluded that "giving women under age 50 a mammogram on a routine basis is close to unethical." Repeat... The experts in the government were told not to do this to healthy women in the YEAR 1974! The warning was ignored.

"Over 280,000 women were recruited without being told that no benefit of mammography had been shown in a controlled trial for women below 50, and without being warned about the potential risk of induction of breast cancer by the test which was supposed to detect it ...in women below 50…mammography gives no benefit..."

Mammography was known to cause cancer but the media and government "health officials" stayed silent! The mammography policy pushed by the American Cancer Society to fill its bank account remained the U.S. government policy for ten more years until a massive Canadian study showed conclusively what was known 20 YEARS earlier (1972) but what was not in the interests of ACS and NCI to admit: X- raying the breasts of women younger than age 50 provided no benefit and probably endangered their lives.

1992. Dr. Samuel Epstein “…The high sensitivity of the breast, especially in young women, to radiation induced cancer was known by 1970, based on research by John Gofman PhD, MD. Nevertheless, the establishment then screened some 300,000 women with x-ray dosages so high as to increase breast cancer risk by up to 20 percent in women aged 40 to 50 who had mammogram annually. Women were given no warning whatever; how many subsequently developed breast cancer remains uninvestigated. “…Additionally, the establishment ignores safe and effective alternatives to mammography, particularly trans-illumination with infrared scanning.

“…For most cancers, survival has not changed for decades. Contrary claims are based on rubber numbers."

Find more information about the risks of breast screening at http://www.leaflady.org/women.htm

Mumps Outbreak may indicate another vaccine failure.

It seems as if this story is just another indicator that the vaccine propaganda is really a failed initiative.

Large Mumps Outbreak Characterized by 2-Dose Vaccine Failure

Authors and Disclosures
Laurie Barclay, MD
Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.
Désirée Lie, MD, MSEd, has disclosed no relevant financial relationships.
Brande Nicole Martin Disclosure:no relevant financial information.

April 9, 2008 — Despite a high coverage rate with 2 doses of mumps-containing vaccine, a large mumps outbreak occurred among midwestern college-age adults who probably received the second dose as schoolchildren, according to the results of a study reported in the April 10 issue of the New England Journal of Medicine. The study authors suggest that a more effective mumps vaccine or changes in vaccine policy may be warranted.

"The widespread use of a second dose of mumps vaccine among U.S. schoolchildren beginning in 1990 was followed by historically low reports of mumps cases," write Gustavo H. Dayan, MD, from the US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, and colleagues. "A 2010 elimination goal was established, but in 2006 the largest mumps outbreak in two decades occurred in the United States."

The investigators reviewed data on mumps cases reported in the United States during 2006, detailed case data from the states that were most highly affected, and vaccination-coverage data obtained in 3 nationwide surveys.

Of 6584 cases of mumps reported in 2006, a total of 76% occurred between March and May, and 85% of patients lived in 8 contiguous midwestern states. Although 85 patients were hospitalized, there were no deaths.

The national incidence of mumps was 2.2 per 100,000. The highest incidence was in persons 18 to 24 years of age, with an incidence 3.7 times that of all other age groups combined; subgroup analysis revealed that 83% of these patients were currently enrolled in college.

Of the patients in 8 highly affected states who had known vaccination status, 63% overall and 84% of those aged 18 to 24 years had received 2 doses of mumps vaccine. National coverage of 1-dose mumps vaccination among preschoolers was 89% or more nationwide and 86% or more in highly affected states during the 12 years preceding the outbreak. In 2006, the national 2-dose coverage was 87% among adolescents, the highest rate in US history.

"Despite a high coverage rate with two doses of mumps-containing vaccine, a large mumps outbreak occurred, characterized by two-dose vaccine failure, particularly among midwestern college-age adults who probably received the second dose as schoolchildren," the study authors write. "A more effective mumps vaccine or changes in vaccine policy may be needed to avert future outbreaks and achieve the elimination of mumps."

Possible explanations for the outbreak may include waning immunity secondary to a lack of natural exposure, or mumps vaccine–induced immunity (derived from genotype A virus) may be less effective against heterologous strains (eg, G genotype).

Limitations of the study include cases of mumps reported through a passive surveillance system with unknown sensitivity; inability to assess vaccine effectiveness with the use of outbreak surveillance data because of high vaccine coverage among patients with mumps; and the ability of laboratory testing to confirm, but not to rule out, mumps.

"Future studies will help to evaluate national vaccine policy, including whether the administration of a second dose of MMR [measles-mumps-rubella] vaccine at a later age or the administration of a third dose would provide higher or more durable immunity," the study authors conclude.

Dr. Dayan, who was employed at the CDC during the preparation of this article, has disclosed being employed at Sanofi Pasteur. Dr. O'Keefe holds an equity interest in Abbott Laboratories, and Ms. Kenyon has received a federal Emerging Infections and Protection grant. The other study authors have disclosed no relevant financial relationships.

N Engl J Med. 2008;358:1580-1589.

Clinical Context
Reports of mumps infection dropped dramatically after the implementation of a policy of 1-dose mumps immunization in 1977 in the United States. In the 1980s, outbreaks of mumps occurred in vaccinated and unvaccinated adolescents and young adults, but since the requirement for 2-dose MMR vaccination, the rates of mumps had decreased with a goal of 2010 for elimination of mumps in the United States.

However, in 2006, the United States experienced the largest mumps epidemic in 2 decades, primarily in 8 midwestern states and in young adults aged 18 to 24 years. The epidemic was unexpected, abrupt, and focal. This study describes patterns associated with the outbreak and vaccination histories of those affected by the epidemic.

Study Highlights
Mumps cases were classified though the National Notifiable Diseases Surveillance System from state health departments to the CDC.
A confirmed case was one that met clinical and laboratory criteria, whereas a probable case met only clinical criteria.
3 times were defined: preresurgence (2000-2005), resurgence (2006), and postresurgence (January - June 2007).
Case data from the 8 most severely affected midwestern states included vaccination status, self-reported ethnicity, and college attendance for 4 states.
Data on mumps vaccination rates were obtained from 4 sources: the US Immunization Survey, the National Immunization Survey, the National Health Interview Survey, and school vaccination surveys.
After 1967, reported mumps cases decreased by 98%, with increased numbers in the 1980s followed by low case counts from 2000 to 2005 when less than 350 cases were reported annually.
In January 2006, mumps cases were noted on college campuses, with a peak occurring in April 2006 and 40 US states reporting 2786 cases.
By December 31, 2006, a total of 6584 cases and 85 hospitalizations for mumps had been reported, with no deaths.
No large outbreaks occurred in primary or secondary schools.
In the postresurgence period, the case rate was 60 per month with a total of 359 cases for 6 months.
In the preresurgence period, the incidence of mumps was less than 1 case per million.
During the 2006 resurgence, the national incidence was 2.2 per 100,000 persons, and 8 states had the highest case counts (range, 170 - 1964) and incidence rates (2.9 - 65.9 per 100,000 persons).
These 8 states accounted for 85% of cases and comprised only 13% of the US population.
Mumps was confirmed by polymerase-chain–reaction assay or viral isolation in all highly affected US states.
The rate of 1-dose vaccination was 78% to 80% among 24-month-old children in the 1980s.
From 1995 to 2006, 1-dose coverage for children aged 19 to 35 months was 90% to 93% and 86% to 96% in the 8 highly affected US states.
From 1997 to 2003, 2-dose mumps vaccine coverage among adolescents aged 13 to 15 years increased from 68% to 77%.
In 2006, 2-dose vaccine coverage between 13 and 17 years was 87%.
In the period from 2006 to 2007, second-dose coverage for kindergartners and first-graders was 81% to 100% (mean coverage, 97%).
In the 8 highly affected US states, 29% of infected persons were aged 18 to 24 years; among those with known vaccination status, 13% had received no vaccine, 25% had received 1 dose, and 63% had received 2 or more doses.
Less than 4% of those younger than 30 years were unvaccinated.
Among those 30 years or older, the proportion of unvaccinated persons increased progressively to 73%.
64% of those infected were women, and whites had an incidence rate twice as high as that of other races or ethnic groups.
Incidence of infection was highest among college students aged 18 to 24 years and recipients of 2 doses of mumps vaccine.
The authors suggested that vaccine failure, waning immunity, high population density, incomplete immunity to wild virus, genotype G virus, and infection imported from another region in the world contributed to the outbreak.
The authors advocated evaluation of national policy on vaccination for mumps including consideration of administration of a third dose to provide higher or more durable immunity.

Pearls for Practice
In the mumps resurgence of 2006, a total of 8 US states representing 13% of the national population were most affected, with 85% of cases.
In the highly affected US states, those who were college students ages 18 to 24 years old, women, white, and those who received a 2-dose schedule of vaccination were most likely to be infected during the 2006 mumps outbreak.

Media Coverage Of Breast Cancer Focuses Too Little On Prevention, Study Suggests

Over the last 40 years too little has been promoted about prevention of cancer. Too little has been done to remove radiation as the main approach to screening, only to promote more cancer. Too little has been done to expose the Race for the Cure as one of the most non-effective fundraising stunts to come along. And too little has been done to fully educate people about the many very effective therapies outside of chemo and radiation; chemo and radiation leading to a very low and ineffective cure rate of 1-2 per cent.

This article gives you some more information -
http://www.sciencedaily.com/releases/2008/04/080415111718.htm

Properly Analyzing Data

This should be available to all the naysayers that wish to convince you that vitamins are bad for your health.

Indeed they are not, and they contribute beneficial nutrients to help you be well and stay well in a toxic world.

However, we remind you that it is important to purchase quality products.

Are anti-oxidants REALLY harmful to you??
From a colleague in the UK, Patrick Holford -

Headlines in today's papers such as 'Vitamin Pills "Increase Risk of Early Death"' claim that anti-oxidants are not good for you and could even do you harm. But, don't believe everything you read!

What's this review about?

This is the fourth time Bjekalovic and his group have reviewed the effects on selected studies on antioxidants. Anyone following the science of antioxidants over the past 20 years will be aware of a vast number of studies reporting positive results. So, how do you end up with a headline that implies antioxidants increase mortality?

In this review, which is a rehash of their paper published last year in the Journal of American Medical Association (JAMA), they first excluded over 400 trials, that had no deaths. They then decided which trials they liked (low risk bias) and did not like (high risk bias), a factor that has received criticism in mainstream medical journals.

What the experts say

One of the world's leading experts in this field, Dr Balz Frei said "This is a flawed analysis of flawed data, and it does little to help us understand the real health effects of antioxidants, whether beneficial or otherwise," (1)

Dr Bernadine Healey, former director of the National Institute of Health said, "Blenderizing these diverse trials into one giant 232,606-patient-strong study to come up with a seductively simple proclamation is just silly. When the researchers tallied up the mortality from the 68 trials, there was no difference based on vitamin intake. The headlines that these supplements significantly increase the risk of death by 5 percent overall came only when the researchers pulled out the 47 trials they deemed to have been the best executed. Actually, in the 21 randomized trials they peeled off, mortality was decreased by 9 percent among those taking the vitamins." (2)

How did they come up with the reported results?

Not surprisingly, the selection process in today's review excluded many of the most positive studies. For example, quoting the review itself, 'In secondary prevention trials (meaning people with disease) with high-bias risk, mortality was significantly reduced by supplements.' In those they called 'low-bias risk' there was no significant change in mortality.

To report an even more negative result, which is what newspapers often home in on, they also excluded all trials on selenium, which actually reduced mortality the most of all the antioxidants considered.

Beta-carotene

As an example, let's look at beta-carotene, which is given the worst rating. The review states 'Beta-carotene used singly or in combination with other antioxidants had no significant effect on mortality when including all 24 trials' BUT 'After exclusion of high-bias risk and selenium trials, however, beta-carotene singly or combined significantly increased mortality in 12 trials.'

Antioxidants and cancer

Even if we were to accept the exclusion of the so-called high-bias risk trials let's look more closely at the apparently negative studies. A graph of all these trials shows five that skew the results towards a negative (p.167). I thought I'd look closer at these trials. The first was by Dr Correa from the pathology department at the Louisiana State University Health Sciences Centre, and showed a clear protective effective of antioxidant supplements against gastrointestinal cancer. (3)

I decided to contact Dr Correa and he was "amazed", he said, because his research, "far from being negative, had shown clear benefit from taking vitamins". Correa told us there was no way the study could show anything about mortality. "Our study was designed for evaluation of the progress of pre-cancerous lesions", he said. "It did not intend, and did not have the power, to study mortality and has no value to examine mortality of cancer."

Vitamin E and statins

The next, called the DATOR trial, gave people with high cholesterol, high dose vitamin E (750iu) and statins. (4) As nutritionists we caution against this because statins stop you making CoQ10 which results in vitamin E becoming a potentially harmful oxidant. That's exactly what this trial reported, "These results indicate that the antioxidant effect of Vitamin E is attenuated (reduced) when given in conjunction with this statin." So these negative effects of vitamin E might actually be because it's taken with a drug that makes it harmful! Given that the majority of the trials included in this review were on sick people, presumably taking medication, this kind of confounding variable really should be taken into account. It is not.

Selenium's protective effects

The next trial, published on the Mayo Clinic's journal, that skewed the results to a negative reported a positive outcome. (5) It investigated the effect of selenium of oesophageal cancer. It found that 'among subjects with mild esophageal squamous dysplasia (early stage) at baseline, selenomethionine did have a protective effect.' For those with more advanced cancer it did not.

In January this year the authors published a paper 'Efficacy of antioxidant supplementation in reducing primary cancer incidence and mortality: systematic review and meta-analysis.'(6) Their conclusion was that 'beta carotene supplementation appeared to increase cancer incidence and cancer mortality among smokers, whereas vitamin E supplementation had no effect. Selenium supplementation might have anticarcinogenic effects in men and thus requires further research.'

So, what does all this mean?

Well, if you look at all the studies reviewed, strictly for reducing mortality, not for other benefits, Bjekalovic concludes 'Beta-carotene, vitamin A and vitamin C, used singly or in combination with other antioxidants had no significant effect' although a number of vitamin C studies did report reduced mortality. 'Selenium used singly or in combination with other antioxidants significantly decreased mortality.' (7). Beta-carotene, as we know, is best not taken singly by smokers. Vitamin E in high dose, as we know, should not be taken by those on statins without additional CoQ10. Selenium and vitamin C are most likely to be beneficial.

So, should we throw away our antioxidants?

Certainly not. Personally, I haven't recommended isolated antioxidant supplementation for 20 years and doubt they would produce much effect in sick people with advanced disease states, except for vitamin C at high doses - a subject not examined in this review. Antioxidants are team players. I take a combination of vitamin E, CoQ10, vitamin C, glutathione, anthocyanidins, resveratrol, beta-carotene, alpha lipoic acid and selenium. There's good reason to do so if you look at what's known about their effects in reducing markers of ageing. But these are as well as eating loads of fruit and veg, nuts and seeds.

Wishing you the best of health.

References

1. http://oregonstate.edu/dept/ncs/newsarch/2007/Feb07/vitaminstudy.html

2. http://health.usnews.com/usnews/health/articles/070304/12healy_print.htm

3. P Correa et al, 'Chemoprevention of gastric dysplasia: Randomized trial of antioxidant supplements and anti-Helicobacter pylori therapy', Journal of the National Cancer Institute (2000), vol 92, pp1881-8.

4. Manuel-Y-Keenoy B et al Impact of Vitamin E supplementation on lipoprotein peroxidation and composition in Type 1 diabetic patients treated with Atorvastatin. Atherosclerosis. 2004 Aug;175(2):369-76]

5. Bardia et al Randomized, placebo-controlled, esophageal squamous cell cancer chemoprevention trial of selenomethionine and celecoxib.Gastroenterology. 2005 Sep;129(3):863-73

6. Bardia A et al Efficacy of antioxidant supplementation in reducing primary cancer incidence and mortality: systematic review and meta-analysis. Mayo Clin Proc. 2008 Jan;83(1):23-34.

7. Bjelakovic et al, Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases (Review), Cochrane Library, Issue 2, 2008