Month: August 2008

By Miranda Hitti

Aug. 18, 2008 — The FDA today said it plans to strengthen warnings about life-threatening pancreas problems linked to the type 2 diabetes drug Byetta after getting two reports of deaths and four other hospitalizations in Byetta users.

Those patients had hemorrhagic pancreatitis (inflammation of the pancreas with bleeding) or necrotizing pancreatitis (in which the inflamed pancreas destroys itself).

All six patients were hospitalized, and their Byetta treatment was stopped. The four survivors were still recovering at the time that the FDA learned of their illness.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected and not restarted if pancreatitis is confirmed, notes the FDA. Byetta, given by injection, was approved by the FDA in 2005.

Last October, the FDA noted 30 reports of acute pancreatitis, which is sudden inflammation of the pancreas, in Byetta users. None of those patients had hemorrhagic or necrotizing pancreatitis.

At the time, the FDA asked Byetta's maker, Amylin Pharmaceuticals, to include information on acute pancreatitis in the "precautions" section of Byetta's label. Now, the FDA is working with Amylin to strengthen and draw attention to warnings about acute hemorrhagic or necrotizing pancreatitis.

Amylin and the drug company Eli Lilly and Company collaborate on Byetta. Amylin spokeswoman Anne Erickson emailed a joint statement from Amylin and Lilly to WebMD.

The companies state that pancreatitis is rare in the general public but more common among type 2 diabetes patients.

In patients using Byetta, there have been "rare" case reports of pancreatitis and "very rare" case reports of pancreatitis with complications or fatalities, and the proportion of complicated or fatal cases is "similar" to that observed in the general public with pancreatitis, according to Amylin and Lilly.

By Shaya Tayefe Mogajer

LOS ANGELES (AP) — Eighteen hospitals in California were fined for state health code violations in which patients received shoddy care that in some cases led to deaths.

Violations included an improperly inserted catheter, a ventilator that wasn't turned on and surgical tools left inside patients after operations.

The fines made public Monday stem from investigations by the California Department of Public Health.

The hospitals were fined $25,000 for each violation — the latest of dozens of penalties the state has issued in recent years to more than 40 hospitals.

"The number of penalties will decrease and the quality of care will dramatically improve as hospitals take action to improve," said Kathleen Billingsley, director of the health department's Center for Healthcare Quality. "The entire intent of these fines is to improve the overall quality of care in California."

The report detailed a death at a La Mesa hospital in which a worker failed to turn on a ventilator for a patient who was being transferred. Another patient in Los Alamitos died after falling from a wheelchair with no seat belt on, and a Santa Ana hospital lost a patient from a medication overdose.

At Doctors Medical Center in San Pablo, a registered nurse improperly inserted a catheter into a patient's neck vein on Sept. 1, and the patient died as a result of an air bubble from the tube. The report found the nurse had not completed a required anatomy class or the hospital's training on protocol.

Defending himself in the report, the unidentified male nurse told investigators, "I am the pro of the hospital. The other nurses call me to put in IVs that they cannot get in."

A message seeking comment from the medical center was not returned Monday.

In other cases, patients had surgical instruments or sponges left inside their bodies during surgery, requiring a second surgery to retrieve the items. The report also found some patients experienced surgical awareness during their procedures due to improper anesthesia.

The state has issued 61 such penalties to 42 hospitals, Billingsley said.

By Steven Reinberg

MONDAY, Aug. 18 (HealthDay News) — Recently discovered so-called free radicals that are attached to small particles of air pollution could cause lung damage and perhaps even lung cancer, researchers report.

If confirmed through further research, the finding could help to explain why nonsmokers develop tobacco-related diseases like lung cancer, said lead researcher H. Barry Dellinger, the Patrick F. Taylor Chair of environmental chemistry at Louisiana State University.

It has been known for years that free radicals exist in the atmosphere, and these atoms, molecules and fragments of molecules can damage cells. It had been thought that these particles, which can be produced by combustion, exist for less than a second and then disappear.
ad_icon

"What I found out is that combustion-generated particles contain environmentally persistent free radicals," said Dellinger. "When the radicals are associated with particles, they can apparently exist indefinitely."

These free radicals are remarkably similar to the free radicals found in cigarette tar, Dellinger said. "The implication is you can have the same environmentally related diseases by exposure to airborne fine particles that you can get from cigarettes," he said.

Dellinger noted, however, that one would have to smoke about 300 cigarettes a day to be exposed to the same level of environmental free radicals found in moderately polluted air.

The findings were to be presented Monday at the American Chemical Society annual meeting, in Philadelphia.

The persistent free radicals (PFRs) discovered by Dellinger's team attach themselves to small particles of air pollution as they leave smokestacks, car exhaust pipes and household chimneys, and continue to exist as free radicals. Particles of air pollution containing metals, such as copper and iron, are more likely to remain in the atmosphere and can carry these PFRs great distances, Dellinger said.

As PFRs are inhaled, they're absorbed by the lungs and other tissues and cause cell damage that can lead to problems such as asthma, emphysema and lung cancer. However, there's still no direct evidence linking PFRs to any of these diseases, he said.

Dr. Neil Schachter, a professor of pulmonary medicine at Mount Sinai Medical Center in New York City, thinks it's premature to blame persistent free radicals for the adverse effects of air pollution.

"These airborne free radicals are of interest, but I am not sure we are at a point where our scalpel is sharp enough to dissect the individual components of air pollution that cause problems for people," he said.

It's possible that persistent free radicals are responsible for the respiratory damage caused by pollution, Schachter acknowledged. "There are studies that show that modifying free radicals can alter the course of disease," he said. "But the implications of this — what it means to clinics, what it means to doctors, what it means to regulators — I think we are a long way from pulling that together."

Despite the many public efforts to promote physical activity and good nutrition in recent years, despite the constant warnings about the obesity crisis, Americans just keep getting fatter. According to an annual state-by-state look at the problem, adult obesity rates increased in 37 states in the past year, and only the District of Columbia saw a decrease—down a mere 0.1%. More than 25% of adults are now obese in 28 states, up from 19 states last year.

In 1991 no state had an obesity rate above 20%. Today more than 20% of adults are obese in every state except Colorado, where the number stands at 18.4%, according to the survey by two nonprofits, the Robert Wood Johnson Foundation and Trust for America's Health. Mississippi, the worst performer of all 51 on the list (which includes the District of Columbia), stands at 31.7%. Similarly disturbing increases were found in the percentage of adults with Type 2 diabetes, a weight-related disease. The survey found higher incidence of diabetes in 26 states. Four states are above 10%.
No Magic Pill

Overall, adult obesity rates have doubled since 1980, from 15% to 30%, and two-thirds of U.S. adults are now considered overweight or obese. The national rate for diabetes in adults has grown from 5.2% in 1980 to more than 8% now, and one in three Americans has hypertension—often weight-related. The report estimates that the direct health-care costs of obesity exceed $61 billion annually.

The U.S. "is not treating the obesity crisis with the seriousness it deserves," said Jeff Levi, executive director of Trust for America's Health at a press conference. He complained that while obesity rates keep climbing, federal funding for programs to address the problem has been steadily reduced over the last several years. "The only thing going down is the money spent to prevent this epidemic."

Plenty of money is also spent by individuals attempting to lose weight, apparently to little avail. The market for weight-loss treatments in the U.S., including diet programs, herbal products, and the like, is worth some $33 billion a year. About $200 million of that comes from prescription products (BusinessWeek.com, 3/8/08) such as Roche's (RHHBY) Xenical and Abbott Laboratories' (ABT) Meridia, none of which work especially well, say obesity experts.
Obesity Policies Receive Failing Grades

The survey found a correlation between poverty and obesity, with 7 of the 10 states with the highest obesity rates also in the top 10 for poverty rates. But wealthy states such as Connecticut, with an obesity rate of 20.8%, have not escaped the problem. There is also a geographic correlation—11 of the 15 states with the highest obesity rates are in the South, while Northeastern and Western states have the lowest rates.

The survey, published in the report F As In Fat: How Obesity Policies Are Failing In America 2008, combines three years of surveillance data spanning 2005-2007 from the U.S. Centers for Disease Control & Prevention. Individuals with a body-mass index of 30 or above, a calculation based on height and weight, are considered obese. For instance, a person who is 5 ft. 8 in. and weighs 200 pounds has a BMI of 30.4.

The two foundations also reviewed state and federal policies aimed at reducing obesity in children and adults and found that, while all 50 states have some sort of law addressing the issue on the books, only 13 back up these regulations with enforcement language, and of those, only four call for sanctions or penalties if the laws are not implemented.
Medicaid Guidelines on Obesity

Only Georgia and Vermont have specific guidelines for treating obese adults in their Medicaid programs. On the other hand, 20 states do not cover nutritional assessments for obese adults under Medicaid, and in Nebraska and South Carolina the Medicaid programs specifically state that obesity is not a disease and treatment cannot be covered.

"There needs to be a sense of urgency and outright alarm," said Dr. James Marks, senior vice-president of the Robert Wood Johnson Foundation. "This is the fifth F As In Fat report and each year we see more evidence that our nation's obesity epidemic continues to gain speed and destructive force." Marks and Levi attributed the steady rise in overweight Americans to large serving-sizes in restaurants, the high cost of nutritional food, and more time spent in front of TVs and computer screens. "No single action or effort led to this change," said Levi, and in the same way no single action will solve it.

Levi and Marks called on governments, parents, schools, and corporations to come up with ways to reverse the fat trend, particularly in children. But leadership, they say, must come from the federal government, which they say has put few resources into fighting obesity. Although they support in principle the Federal Obesity Prevention Act legislation introduced in July by Senators Chris Dodd (D-Conn.), Tom Harkin (D-Ind.), and Jeff Bingaman (D-N.M.), calling for a national strategy for combating obesity, they worry the funding won't be there. "A strategy alone is insufficient if resources are not placed behind it," said Levi.

"These findings have potential clinical implications," the researchers wrote, "as they suggest that long-term rosiglitazone usage in the treatment of Type 2 diabetes and insulin resistance may cause osteoporosis, owing to a combination of decreased bone formation and increased bone resorption."

Researchers monitored the effects on bone breakdown and formation in mice that had been given Avandia. They found that the activity of osteoclasts was increased in the animals, leading to a loss of bone mass.

Osteoclasts are cells that continually destroy old bone in the body. In a healthy body, the same amount of bone is then created by cells called osteoblasts. In the mice taking Avandia, increased osteoclast activity without a concurrent increase in osteoblast activity lead to bone loss.

When the researchers blocked the gene that Avandia targets, however, the mice's osteoclasts failed to mature properly, leading to an increase in bone mass instead. According to the researchers, this suggests a new area of research for treating osteoporosis.

GlaxoSmith Kline has reported a greater risk of hand, upper arm and foot fractures in patients taking Avandia, but a company spokesperson said that GlaxoSmith Kline is not aware of any increase in the spinal fractures that are commonly associated with osteoporosis.

Controversy over Avandia erupted in May, when the FDA issued a warning that the drug raised the risk of heart attack and death among patients taking it. Since that time, prescription of the drug has dropped in the United States, but has continued to increase in parts of Europe. More than 1.5 million prescriptions for rosiglitazone and the related drug pioglitazone were given out in 2006.

by Lyndsay Moss

Injections of vitamin C could halve the growth of cancerous tumours, research suggested yesterday. A study in the United States found that the vitamin could prove useful in treating cancers for which few other options currently exist.

The breakthrough, which comes following tests on mice, follows decades of research into the potential of vitamin C in tackling cancer.

However, experts warned that the benefits of the vitamin had yet to be demonstrated in human patients.

For the latest study, researchers from the National Institutes of Health in Bethesda, Maryland, examined the effects of vitamin C on cells grown in laboratories. Two hours of exposure to the vitamin significantly cut the survival of ovarian, pancreatic and brain tumour (glioblastoma) cancer cells.

Similar results were seen when cancer-ridden mice were injected with vitamin C. The therapy halved the growth of aggressive tumours, killing cancer cells while leaving healthy tissue unharmed.

It is thought the discovery could provide a new lifeline for patients with a poor prognosis and few other options.

Tackling cancer with vitamin C would also have the added advantage of being cheap compared with many of the very expensive cancer treatments.

Usually the body keeps a tight rein on high vitamin C levels in the blood. But the scientists found that the mechanism can be by-passed if the vitamin is injected straight into the blood instead of passing through the digestive system. When this is done it releases the powerful anti-cancer potential of the vitamin, according to the researchers writing in the journal Proceedings of the National Academy of Sciences.

The experiments showed that high levels of vitamin C in the blood generate hydrogen peroxide, which is lethal to tumours. The chemical forms in the spaces between cancer cells, damaging membranes, upsetting metabolism and scrambling the DNA of the tumour.

Even the growth of aggressive cancers was held back in the experiments. But healthy tissues appeared to resist the effects.

The use of high-dose vitamin C as an alternative cancer treatment has a long history dating back to the 1970s. Patients have taken the vitamin both by mouth and intravenously, but with mixed results in scientific trials. For this reason, claims that vitamin C can treat cancer have been dismissed by conventional cancer experts. But the new investigation, led by Dr Qi Chen, may help to start changing attitudes towards this approach.

The scientists said: "Pharmacologic concentrations of ascorbate (the chemical name for vitamin C] decreased tumour volumes 41-53 per cent in diverse cancer types known for both their aggressive growth and limited treatment options."

Dr Alison Ross, science information officer at Cancer Research UK, said: "This is encouraging work but it's at a very early stage because it involves cells grown in the lab and mice."

Dating back to the beginning of last century mineral depletion in our soils, and thus in the food we eat, has been horrendous – and it has gotten much worse in recent decades, as we strip the top eight feet of soil throughout the world of the vital major minerals and up to 80 trace minerals that man has adapted to for thousands of years and which are needed for optimum health.

The way nature works in a more or less "natural" state is that tree roots go deep in the soil and bring up vital minerals that are replaced as the trees die and decompose.  In addition, animals that eat and contain the minerals themselves die and decompose and are returned to the soil.  Similarly, animal and human waste matter is returned to the soil.

In modern times, we have disrupted the natural cycle of mineral replenishment by clear-cutting the forests and trees to make crop land, removing most of the waste and dead animals, and we have over-farmed virtually all of our soil without allowing time for micro-organisms to convert the remaining minerals into usable forms for plants.  Thanks to the advent of petro-chemical fertilizers in 1908, we have mostly returned to the soil only petroleum derived nitrogen, potassium and phosphorus – which produce lush growth but nutrient-poor plants.

To make matters worse, we have applied pesticides and herbicides that have killed off vital micro-organisms which help convert remaining soil minerals to usable forms.

Thanks to the extended use of fertilizers and "maximum yield" mass farming methods the soil in the North American continent has had an average of 85% mineral depletion over the past 100 years – the worst of any other country in the world.

The end result is that a bowl of spinach most of us eat today contains perhaps 1/8th the nutrition of the bowl our grandparents and great grandparents ate.

The role of minerals and human health is immense, yet seldom recognized.  Two times Nobel Prize winner Linus Pauling went so far as to state unequivocally "You can trace every sickness, every disease, and every ailment to a mineral deficiency."

Dr. Gary Price Todd echoed this sentiment when he stated, "The lack of minerals is the root of all disease."

Considering that minerals are the most basic of building blocks for proper nutrition and health, such statements can hardly be considered exaggerations.  Quite simply, without minerals, nothing else works.  Amino acids and enzymes don't work and so vitamins and other nutrients don't get broken down and absorbed properly and we end up with major deficiencies in both vitamins and minerals. The end result is a chain reaction of poor health where nothing works as it should.

"In the absence of minerals, vitamins have no function. Lacking vitamins, the system can make use of the minerals, but lacking minerals vitamins are useless."

– Dr. Charles Northern, researcher and MD

Another major area where mineral deficiency manifests itself, in addition to poor health and immune system support, is obesity.  Similar to the cats and dogs one sees eating grass when they instinctively know they are either deficient in vitamins and minerals or need extra ones to combat an illness or infection, I believe that the human body also sends such instinctive signals at times that it is missing vital nutrients, but we no longer recognize what it is our bodies are telling us and where to find what we need to silence the signals.

Such confused signals often lead to cravings, and so we eat and eat to try to satisfy them, but what we really crave is missing nutrition.  Instead of turning to a nutritious diet or other healthy way to furnish minerals (such as the plant derived minerals from the prehistoric clays in Utah available from Utopia Silver), we turn to the SADS diet, fast foods, nuked meals, sweets, junk food, etc. often to no avail. Perhaps many of us can relate to that familiar quandary of eating and eating to the point of being gorged, and yet still feeling hungry for "something".  That something very often is likely minerals!

Coming Installments:

"Measuring the Loss of Minerals in our Soils and Foods"
"Gone Without a Trace – Our Essential Disappearing Trace Minerals"
"Heading off a Health Disaster – Replacing our Lost Minerals"

Live long, live healthy, live happy!

About the Author:
Tony Isaacs, is a natural health advocate and researcher and the author of books and articles about natural health including "Cancer's Natural Enemy" and "Collected Remedies". Mr. Isaacs hosts The Best Years in Life website for baby boomers and others wishing to avoid prescription drugs and mainstream managed illness and live longer, healthier and happier lives naturally (http://www.tbyil.com). He also hosts the CureZone "Ask Tony Isaacs" forum as well as the Yahoo Health Group "OleanderSoup”.  Mr. Isaacs is currently residing in the scenic Texas hill country near Utopia, Texas where he serves as a consultant to the Utopia Silver colloidal silver and supplement company and where he is working on a major book project.