GOT Arthritis?

I read something on this issue last week and haven't had time to get it up on Natural Health News or get my comments posted either.

What is of interest to me is the high percentage of people reporting increases in the signs and symptoms of arthritis, 22%.


In the early 90s a rise in arthritis was being reported too.  Back then the concerns were included in the reporting.


Some of the concerns about 20 years ago included water fluoridation; lack of exercise; poor diet and poor nutrition; not eating meat, move to use of PUFAs (polyunsaturated oils); continuing focus on low fat and non fat diet schemes; over use of artificial sweeteners; reliance on drugs that offered more side effects, even death, than relief; over use of NSAIDS leaving many with serious side effects and in some cases kidney and liver failure or death.

I am sure I am leaving some things out, but I do not want to exclude this important item:

As more and more processed and convenience type food, microwave cooking, and anti-nutrition methods began to take over modern food preparation, making broth fell by the wayside.  Making broth from bones is a very easy process and the end product is filled with nutrients that protect joint function.

Eating meat is also fallen by the wayside, and because of this, people take in less natural CLA, cetyl myristoleate, and health promoting saturated fat.  


Changes in this pattern also may be related to increasing fertility problems, as well as obesity concerns and other health problems now not being able to be diagnosed.

This won't be halted by a drug.


from AP

A surprising jump in the number of Americans hobbled by arthritis may be due to obesity, health experts said Thursday.

About 22 percent of U.S. adults have been told by a doctor that they have arthritis, the Centers for Disease Control and Prevention reported. The statistic comes from national telephone polling of tens of thousands of adults in 2007 through 2009.

That translates to nearly 50 million people with the joint disease. It's also roughly the same percentage with arthritis as reported in a 2003-2005 study.

But there was a significant jump in adults who said their joint pain or other arthritis symptoms limited their usual activities, to 9.4 percent from 8.3 percent. That means more than 21 million adults have trouble climbing stairs, dressing, gardening or doing other things, up from less than 19 million only a few years before, the CDC researchers estimated.

That jump was "more than we would have expected," said Dr. John Klippel, president of the Atlanta-based Arthritis Foundation.

Klippel said the increase probably was due mainly to baby boomers, who are at an age when they are more likely to suffer osteoarthritis, the most common form of arthritis. It breaks down cartilage and causes pain and joint stiffness.

He added that a complicating factor is high rates of baby boomers who are overweight and obese. Extra weight puts more pressure on arthritic joints, making the problem worse, he said.

The percentage of people who were hobbled was more than twice as high in obese people as those who were normal weight or were underweight, the CDC researchers found. Obesity can lead to or worsen osteoarthritis in the knees, the researchers wrote.

The study is published in a CDC publication, Morbidity and Mortality Weekly Report. SOURCE

And in case you do not follow health history, here is a review from 2004 -

February 2004 - Mother was right about cod liver oil
At a press conference held at the Royal College of Surgeons in London on February 12 2004 , researchers from Cardiff University in Wales announced the results of a study which found for the first time in humans that cod liver oil really is effective in slowing the progression of osteoarthritis. The team, led by Professor Bruce Caterson and Professor John Harwood of Cardiff University, and Professor Colin Dent, of the University of Wales College of Medicine, provided two extra strength cod liver oil capsules per day to arthritis patients ten to twelve weeks before knee replacement surgery and found that 86 percent of the participants experienced a partial or complete reduction in the enzymes that cause cartilage damage, compared to 26 percent of a placebo group. Enzymes that cause joint pain were also reduced in the cod liver oil group.
Professor Caterson commented, "This breakthrough is hugely significant because it demonstrates the efficacy of a dietary intake of cod liver oil in patients with osteoarthritis taken prior to their joint replacement surgery. The data suggests that cod liver oil has a dual mode of action, potentially slowing down the cartilage degeneration inherent in osteoarthritis and also reducing factors that cause pain and inflammation. What these findings suggest is that by taking cod liver oil, people are more likely to delay the onset of osteoarthritis and less likely to require multiple joint replacements later in life.”
Professor Dent added, “Patients resort to joint replacement surgery when the symptoms and pain of their arthritis becomes unbearable. Cod liver oil can counteract these symptoms and if you can switch off the cartilage destruction and pain then surgery may not be necessary. We're very excited by this latest trial."

It is nice to recall that I learned in the 60s just how useful cod liver oil is for the "itis" category.  Wouldn't it be nice if this is what you had been reading instead of all about the dangerous drugs prescribed, pushed by Big PhRMA? 

Jolly Joints

Regular exercise is essential to preserving your health—and it’s even more important if you suffer from arthritis, since losing excess weight and increasing your strength can help to lighten the load on your joints in the long run. The key is to find supplements that can minimize your exercise routine’s more damaging effects—while still allowing you to reap the many benefits of physical activity. (courtesy VRP)

Glucosamine is one of the most popular and effective answers to this common paradox, with research showing that this cartilage-supporting molecule can significantly relieve inflammation, while improving your joint function and combating degeneration.

Additional joint-protective compounds can work in tandem with glucosamine to enhance its effects—most notably chondroitin sulfate and methylsulfonylmethane/MSM, which can reduce pain and swelling, slow your joints’ breakdown, plus increase flexibility and mobility.

Plus its great for longevity-

In a prospective, cohort study involving 77,719 residents of Washington state, between the ages of 50 and 76 years, who were followed for an average of 5 years, during which 3,577 deaths occurred over the course of 387,801 person-years of follow up, supplementation with glucosamine and chondroitin were each associated with reductions in total mortality (HR=0.83 and HR=0.83, comparing high intake, defined as > or = 4 d/wk for > or = 3 years to low intake). In addition, high intake of fish oil was associated with a reduced risk of total mortality as well (HR=0.83), however the test for trend was not significantly significant. These results suggest that regular long-term supplementation with glucosamine and/or chondroitin may reduce the risk of total mortality.

We offer bulk glucosamine, MSM, chondroitin, Nutri-Joint and Nutri-Joint for pets

Try Backward walking

Gluten allergy boosts death risk

This is a timely report in terms of the article below about current cancer therapies, and the fact we have known for decades that cancer is most often a nutritional disease.

Not too long ago I wrote to a physician who is doing gastrointestinal work and with people who have rheumatoid arthritis. I asked him if he was screening his patients for gluten and gliaden allergy and allergy to other foods.

You guessed it, the answer was 'NO'.

I think this article represents a start, but the movement has to continue. It may be up to you, instead of asking for reflux drugs, to demand proper food allergy testing. The system I use tests for 250 different foods.

Don't overlook the impact of vaccines in this equation either.

Tue Sep 15
CHICAGO (AFP) – The risks of gluten allergies have been underestimated, according to a study published Tuesday which found increased mortality rates among people with celiac disease.

Celiac disease is triggered by exposure to gluten, a protein found in wheat, rye and barley.

Found in about one percent of the Western population, it damages the small intestines and interferes with the absorption of nutrients from food.

People with celiac disease often also have other diseases which attack the immune system such as diabetes or arthritis.

However, celiac disease often goes undiagnosed until substantial damage has been done to the digestive system.

Using data taken from biopsies taken between July 1969 and February 2008 in Sweden, researchers were able to examine the overall risk of death in individuals with celiac disease and digestive inflammation and compare it to the general population.

They found the risk of death was "modestly increased."

Patients with inflammation had a 72 percent increased risk of death; patients with celiac disease had a 39 percent increased risk; and patients with latent celiac disease had a 35 percent increased risk of death.

Lead author Jonas Ludvigsson of the Orebro University Hospital concluded that there could be several explanations for the increased mortality risks.

"Malnutrition of energy and vitamins and chronic inflammation may increase the risk of death," he wrote, noting that even patients who maintain gluten-free diets have persisting lesions.

Those with inflammation who had not been diagnosed with celiac disease may have an overall worse prognosis because institution of a gluten-free diet often leads to normalization, the authors concluded.

"Until recently, gluten sensitivity has received little attention in the traditional medical literature, although there is increasing evidence for its presence in patients with various neurological disorders and psychiatric problems," Peter Green of Columbia University College of Physicians and Surgeons wrote in an accompanying editorial.

"The study by Ludvigsson and colleagues reinforces the importance of celiac disease as a diagnosis that should be sought by physicians. It also suggests that more attention should be given to the lesser degrees of intestinal inflammation and gluten sensitivity."

The risk of death was highest in the first year of follow-up but decreased with age at diagnosis, with risk being higher for those diagnosed before age 20.

The study was published in the Journal of the American Medical Association.

Cherries, an old and effective remedy

UPDATE: Cherries for Insomnia  July 2010 -

Tart cherry juice may reduce insomnia

SAN ANTONIO, July 14 (UPI) -- Drinking tart cherry juice daily may help fight insomnia because it contains melatonin, which moderates the body's sleep-wake cycle, U.S. researchers suggest.

Researchers at the University of Pennsylvania, University of Rochester in New York and the VA Center of Canandaigua in New York had 15 adults drink 8 ounces of tart cherry juice beverage in the morning and evening for two weeks. They compared this to a comparable juice drink, with no tart cherry juice, given for another two-week period.

Those who drank the tart cherry juice saved about 17 minutes of wake time after going to sleep, on average, and reported significant reductions in insomnia severity, while those who drank the other juice drink has little change in insomnia.

"When consumed regularly, tart cherries may help regulate the body's natural sleep cycle and increase sleep efficiency, including decreasing the time it takes to fall asleep," Russel J. Reiter, a biomedical scientist at the University of Texas Health Science Center, who is an authority on melatonin, says in a statement. "And, because cherries are so rich in other antioxidants, such as anthocyanins, you get other important health benefits."

The findings are published in the Journal of Medicinal Food.© 2010 United Press International, Inc. All Rights Reserved.

---------------------------------------------------------------------------------------------------------------------------------------------------------------
Cherries have been used for how many decades now, I can't recall because its been sooooo long. Mention of cherries can be found in the literature of the ancient Chinese, Greeks and South Asians.

Maybe its just that extra vitamin C and potassium along with those nice red and juicy antioxidants. I often add Bernard Jensen Black Cherry concentrate to my berry smoothies, not only for taste, but for added nutrition.

Cherries with ricotta cheese help you sleep and fight cancer because of all the extra melatonin and proanthocyanidin. They even offer some hops to people with diabetes.

"A growing body of science reveals tart cherries, enjoyed as either dried, frozen cherries or cherry juice, have among the highest levels of disease-fighting antioxidants, when compared to other fruits. They also contain other important nutrients such as beta carotene (19 times more than blueberries or strawberries) vitamin C, potassium, magnesium, iron, fiber and folate.

Emerging evidence links cherries to many important health benefits – from helping to ease the pain of arthritis and gout, to reducing risk factors for heart disease, diabetes and certain cancers. Cherries also contain melatonin, which has been found to help regulate the body’s natural sleep patterns, aid with jet lag, prevent memory loss and delay the aging process."

So it seems that after the government food police interference decided the cherry board can't make a claim at all about how this glorious fruit helps and perhaps even cures arthritis, medicine once again sticks in a dirty finger. Could it be leading to control the cherry crop?

FDA Threatens To Raid Cherry Orchards

I guess you have to be the judge.

And remember to tell your member of congress - NO on HR 875!

Can Cherries Relieve The Pain Of Osteoarthritis?

ScienceDaily (2009-03-21) -- For the estimated 27 million Americans who suffer from osteoarthritis, pain relief may come with a cherry on top. According to researchers, tart cherries, in pill form, may be a promising pain-reliever for this common and debilitating form of arthritis. ...  read full article

Overlooked Health Consequences

UPDATE: 9 March 2010

Virus infections may be contributing factor in onset of gluten intolerance

ScienceDaily (2010-03-07) -- Recent research findings indicate a possible connection between virus infections, the immune system and the onset of gluten intolerance, also known as celiac disease. ... > read full article

UPDATE: 18 February
Shingles is readily treated and resolved with herbal compounds. Historically Black Walnut tincture was used to apply externally to the patches, although I have found that Valerian root tincture can be effective. Valerian may be taken inernally to help with the pain, and St. John's Wort, an effective anti-vital herbal tincture, may be used alone or in combination with Valerain for pain and help fighting the virus.
Flower essence of Impatiens can be an adjuct treatment, as in the original development of Bach's remedies he found in his hospital provings that Impatiens essence was as effective as morphine, yet it had no untoward effects.

Shingles 'risk' of arthritis drug
Some popular treatments for rheumatoid arthritis could increase the risk of the painful condition shingles, a German study suggests.

Anti-TNF (anti-tumour necrosis factor alpha) therapy drugs can slow the progress of disease and help to reduce some of the worst symptoms.

But some of them may make patients more vulnerable to shingles, a skin disease which produces sore, itchy blisters.

Writing in JAMA, the authors advised patients on such drugs be monitored.

The team at the Rheumatism Research Centre in Berlin analysed data from more than 5,000 patients on different forms of treatment.

There were 86 outbreaks of shingles - triggered by the virus Herpes zoster - among 82 patients. Thirty-nine of these coincided with treatment with the anti-TNF drugs adalimumab and infliximab.

Etanercept, a protein therapy, and conventional disease-modifying anti-rheumatic drugs were associated with 23 and 24 cases respectively.

Watchful eye

After adjusting for the age of the patient, the severity of their illness and their use of steroid hormone therapies, researchers found that the risk for patients on the anti-TNF programme almost doubled.

“ All drugs which damp down the immune response run the risk of increased risk of infection ”
Professor Alan Silman
Arthritis Research Campaign

Although this was beneath the threshold of clinical significance, which would be an increase of more than double, the researchers, led by Dr Anja Strangfeld, said their findings suggested doctors should be on the look out for shingles in the patients they treat with these drugs.

"Based on our data, we recommend careful monitoring of patients treated with monoclonal anti-TNF-alpha antibodies for early signs and symptoms of Herpes zoster," they wrote in the Journal of the American Medical Association.

Shingles is the reactivation of the virus infection that causes chickenpox. After a person has had the infection, usually as a child, the virus remains in their body and can return, usually after the age of 50.

It often first manifests as pain, itching or tingling in an area of skin on one side of the body or face before developing into a rash. Many continue to suffer chronic nerve pain once the rash has subsided.

A weakened immune system is thought to be one of the triggers, and it is suggested that this may be why anti-TNF drugs could have this effect.

"All drugs which damp down the immune response run the risk of increased risk of infection; steroids being a well known example," said Professor Alan Silman, medical director of the Arthritis Research Campaign.

"Shingles is also a rare but well recognised complication of immune drugs used to treat both autoimmune disorders such as rheumatoid arthritis as well as cancers. This distressing but fortunately treatable infection is likely to be increased in incidence in anti-TNF treated patients."
Story from BBC NEWS:http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/7895202.stm
Published: 2009/02/18 © BBC MMIX

I have known for decades the benefits of cod liver oil for arthritis. Seems funny that it has taken so long to reach the hallowed halls of the BBC.

Cod oil 'cuts arthritis drug use'
A daily dose of cod liver oil can cut painkiller use in patients with rheumatoid arthritis, a study suggests.
Taking 10g of cod liver oil a day reduced the need for non-steroidal anti-inflammatory drugs (NSAIDs) by 30%, Dundee University researchers say.

Concerns about side-effects of NSAIDs has prompted research into alternative.

Rheumatologists said the study, in Rheumatology journal, funded by Seven Seas, was small but showed fish oil could benefit some patients.

Patients in the trial were either given cod liver oil or placebo and after 12 weeks asked to gradually reduce their use of NSAIDs, such as ibuprofen.

“ Anything that can help to reduce NSAID use is going to be safer for patients ”
Dr Andrew Bamji, British Society for Rheumatology

Almost 60 patients completed the nine-month trial which found 39% taking cod liver oil reduced their daily dose of NSAIDs compared with 10% taking a placebo.

The reduction in drug use was not associated with any worsening of pain or the disease, the researchers reported.

The research team at the University of Dundee, aided by colleagues at the University of Edinburgh, have now completed three studies which have all shown patients are able to cut down their NSAID use when taking cod liver oil.

It is thought fatty acids in the fish oil have anti-inflammatory properties.

Side-effects

Some side-effects of NSAIDs, such as an increased risk of stomach bleeding have been known for a long time.

But more recently, concerns have been raised about an apparent increased risk of heart attacks and strokes in those taking the drugs.

Study leader Professor Jill Belch said the study offered hope to many rheumatoid arthritis patients who wanted to reduce the amount of pain medication they take.

"Every change in medication should be discussed with a GP but I would advise people to give cod liver oil a try for 12 weeks alongside their NSAIDs and then try to cut it down if they can manage it but if they don't manage it, that's fine.

"If you can get off NSAIDs it will be much safer."

National Rheumatoid Arthritis Society chief executive Ailsa Bosworth said: "People with rheumatoid arthritis still rely heavily on NSAIDs, even though the safety of these drugs is under scrutiny.

"We look forward to more research in this area."

British Society for Rheumatology president Dr Andrew Bamji said it was a small study so difficult to draw firm conclusions.

But he added: "Anything that can help to reduce NSAID use is going to be safer for patients.

"It does look as if the results are positive and that is quite interesting.

"I would say to patients by all means take cod liver oil and when you feel ready start to reduce your NSAID dose."

But he stressed that patients must discuss plans with their doctor because it was important that physicians were aware of all medications and supplements the patient was taking.

Story from BBC NEWS:http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/7307298.stm
Published: 2008/03/25 © BBC MMIX

Originally posted 20 January
TV adverts make me angry.

One reason is because I do not think these ads should be on TV. Secondly I think the ads are disease mongering and an effort to increase profits for Big Pharma.

One new ad I saw the other day while flipping channels, since I am not a TV addict or fan, was an ad for Humira in the treatment of psoriasis.

Notwithstanding, Humira is used as a treatment for rheumatoid arthritis and other so described "auto-immune" disorders.

Humira(adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). This means it is a genetically modified product, that in itself creates a plethora of problems.

Humira has a Black Box warning for the risk of tuberculosis. Other serious sided effects may include serious infections, neurologic reactions and malignancies. More information may be found in the professional section at RxList.com.

I'm in the midst of writing the January issue of my opt-in newsletter, herbalYODA Says! The topic happens to be detoxification and as part of my research I came across an interesting piece of information about non-Celiac gluten sensitivity.

I happen to be someone with gluten and gliaden sensitivity. I have many other food allergies which I attribute to certain situations I experienced in the last couple of decades which took a pretty devastating toll on my adrenals.

I'd say there were some other factors because my father had psoriasis. It isn't something I have but I have helped many people who lived with this condition, from mild to severe, to resolve their case.

This of course alerts me to the fact that I probably should not ever have had bread. It also has to do with heritage and the metabolic typing as developed by William D. Kelley, DDS.

Simply what this means is that there are certain symptoms of gluten and gliaden intolerance, even if you do not have Crohn's.

Conditions Often Associated With Gluten Sensitivity
From 'Going Against the Grain' (Chicago, IL: Contemporary Books, 2002) by Melissa Diane Smith

Autism
Autoimmune diseases
Chronic neurological conditions of unknown cause
Dermatitis herpetiformis (a blistery, itchy skin disease)
Downs syndrome
Epilepsy and/or a personal history of migraine headaches, hyperactivity and/or digestive problems
Frequent unexplained headaches
Osteoporosis and other bone diseases unresponsive to conventional treatment
Infertility and pregnancies of poor outcome
Insulin-dependent (type I) diabetes
Intestinal lymphoma or esophageal cancer
Psoriasis
Schizophrenia
Sjogren’s disease (dry-eye, dry-skin syndrome)

I find it interesting that Sjogren's is on this list along with psoriaisis, as Humira is often prescribed for Sjrogren's as well.

I noted in some other data that esophageal cancer is related to gluten intolerance (wheat allergy) and the articles I found on this date back to the 1970s.

This is the long way around but if you have any of these health issues perhaps you want to demand your doctor to order some food allergy testing, and re-consider Humira.

Or at least ask why your health care provider missed this one.

If your doctor looks at you like you are crazy then refer them to this study -

The innate immune system is an old system (evolutionarily speaking) that predates the antibody-producing “adaptive immune system” and nonspecifically defends against pathogens.

Biopsies from 5 out of 6 patients showed an IL-15 response to at least one gliadin fragment. The implication is that the majority of people have an immune response to wheat, even if they don’t have Celiac disease. The reason they aren’t diagnosed as Celiac patients is they don’t have circulating anti-gliadin antibodies (and they presumably don’t yet have severe structural damage to their intestinal tract as judged by biopsy or endoscopy), but as the paper shows, people can react to gluten without producing antibodies via the innate immune system.

This is the first time that an IL-15-mediated innate response to gliadin is described in individuals without celiac disease. The authors of the study believe that “gluten elicits its harmful effect, throughout an IL-15 innate immune system response on all the individuals. This innate response is found in both patients with and without celiac disease.” However, in patients with celiac disease, an adaptive response to gluten also takes place.

Study reference: Bernardo D, Garrote JA, Fernandez-Salazar L, et al. Is gliadin really safe for non-coeliac individuals? Production of interleukin 15 in biopsy culture from non-coeliac individuals with gliadin peptides. Gut, 2007;56:889-890.

Six people in the study had symptoms including gastroesophageal reflux disease (GERD), hiatal hernia, colic, abdominal pain, diarrhea and chronic gastritis. How many people have these conditions and take medications for them instead of considering that the bread, pasta and other wheat products they are eating may be the culprit behind their problems?

or have them look up the work of Kenneth Fine, MD or Alessio Fasano, M.D.

There is just more here than meets the eye - "Many gluten-sensitive make the mistake of substituting too many non-gluten grains (rice, corn, millet, buckwheat, quinoa, amaranth and teff) and sugars in place of gluten grains. This can lead to carbohydrate sensitivity and conditions such as Syndrome X and type II diabetes. To prevent the development of a new health problem, emphasize vegetables, such as salad greens, broccoli, green beans and asparagus, in place of gluten grains."

If you are interested in food allergy testing, the same system I used to uncover mine, please contact us.

By the way, one of my original teachers in natural healing always taught that RA and gluten allergy go hand-in-hand.

Certainly altering your nutrition and food plan first can do a lot before you succumb to another dangerous drug, and it just might heal your condition.

Beware, genetically engineered and newer biological drugs

There is a rather well publicized issue surrounding multiple myeloma and the possibility of symptomatic treatment from a drug in this class that is approved for MS and Crohn's Disease. One of the serious side effects of the drug is that it can cause multiple myeloma and a very severe bacterial invasion of brain tissue that can be fatal. The drug is listed on the FDA's drug advisory information pages. These are reasons why the drug is so tightly controlled. Another may be that the effects of the drug really isn't known because no long term studies are completed before FDA approval and marketing.

Humira and other arthritis drugs have been worrisome for years, the risk of cancer has been raised, yet they are still plentifully prescribed.

Some forms of arthritis are well known to be associated with food allergy but this concept is absent or fleeting over (knee-jerk) consideration for promoting the drug.

Some cases of Chrohn's may be helped with more nutritional and natural approaches to revitlize the gut lining and function. Now this is a novel idea in MSM but its one I've seen work time and time again.

MS and multiply myeloma can be helped with more natural approaches too.

There just needs to be a better approach to health care.

Safety a problem for new generation drugs, tooBy LINDSEY TANNER, AP Medical Writer

He said the results simply show that doctors and patients should be aware that the drugs have many potential side effects that may not be listed on the label.

CHICAGO – Nearly a fourth of widely used new-generation biological drugs for several common diseases produce serious side effects that lead to safety warnings soon after they go on the market, the first major study of its kind found.

Included in the report released Tuesday were the arthritis drugs Humira and Remicade, cancer drugs Rituxan and Erbitux, and the heart failure drug Natrecor. All wound up being flagged for safety.

That might surprise some doctors who may have thought that these new treatments might be safer than traditional chemical-based medicines.

Researchers found that most of the warnings came within five years after these biologicals won government approval in the United States and Europe between 1995 and 2007.

Many traditional medicines wind up with safety warnings too after they go on the market. But experts said there were no similar studies of older medicines that made it possible to compare safety issues between the two groups of drugs.

The new study, by Dutch researchers, is the first comprehensive examination of these newer medicines, a driving part of the biotech revolution.

The drugs are known as biologicals because they're made from living material and they typically affect the body's disease-fighting immune system. Many relieve severe symptoms by suppressing that system.
It's that same mechanism that can result in side effects often not seen with traditional chemical-based medicines, said Dr. Charles Bennett, a Northwestern University drug safety expert. These can include brain and fungal infections and cancer.

Many are genetically engineered and Bennett said that because they typically resemble naturally occurring proteins, many doctors have assumed they were safer than traditional chemical-based medicines. But he said the study shows that's not necessarily true.

"They have an important role," Bennett said. "They're really the next generation of pharmaceuticals."

He said the results simply show that doctors and patients should be aware that the drugs have many potential side effects that may not be listed on the label.

Among the drugs under examination are Genentech Inc.'s psoriasis drug Raptiva, which just last week the Food and Drug Administration warned may contribute to a life-threatening brain illness and infections; and Exubera, an inhaled insulin product, linked with lung cancer risks. Exubera was approved by the FDA in 2006 but Pfizer Inc. stopped selling it last year.

The study appears in Wednesday's Journal of the American Medical Association.

It involved 136 biologics approved in the United States and 105 in the European Union between January 1995 and June 2007. A total of 41, or nearly 24 percent, got safety warnings issued through June 2008.

The results are a concern, and they underscore the need for closer scrutiny of drugs after their approval, said lead author Thijs Giezen of the University of Utrecht.

But he said the study also is reassuring because most problems showed up relatively soon after the drugs became available, which minimized the potential for widespread harm.

"If most issues are discovered within the first few years, then the system is working," Giezen said.

Bennett says it's unreasonable to think that the studied drugs' safety issues should have been discovered before they were marketed. That's because drug approval is based on relatively small studies with patients who generally are healthier than those in the general population. It often takes real-world experience for side effects to appear, he said.

Many biological drugs have advantages over conventional medicine, but the study shows their risks need to also be considered, said Thomas Moore of the Institute for Safe Medication Practices.

For example, non-steroid arthritis medicines including ibuprofen can reduce pain by decreasing inflammation, but they can cause stomach bleeding.

Biologic rheumatoid arthritis medicines Remicade, Enbrel and Humira are designed to ease painful joints by keeping the body's immune system from attacking itself, the underlying problem in the disease. But they are much more expensive and have been linked with higher risks for potentially fatal infections. Also, the FDA is investigating possible cancer risks.

"My message to patients is that these biological products often can treat very difficult to treat diseases but may have very substantial risks and that you need to take extra care to educate yourself as to what those risks might be," Moore said.

And in another report on this timely topic -

Reports of serious drug reactions hit recordBy RICARDO ALONSO-ZALDIVAR, Associated Press Writer

WASHINGTON – The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new record, a health industry watchdog group said Wednesday.

The Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including more than 4,800 deaths, said an analysis of federal data by the Institute for Safe Medication Practices.

Two drugs accounted for a large share of the latest reports. One was the blood thinner heparin. Most of the drug's problems were prompted by tainted heparin imported from China. The other was Chantix, a new kind of anti-smoking drug from Pfizer.

Chantix, which had the most reports of any medication, works directly in a smoker's brain to ease withdrawal symptoms. It also blocks the pleasurable effects of nicotine if the patient is tempted to light up again. Earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. Pfizer said Wednesday it stands by Chantix, and that the volume of reports might be linked to publicity about the side effects.

"The FDA is aware of the increasing number of reports, and we take them seriously," said spokesman Christopher DiFrancesco. But officials are not sure whether reports are up because problems are getting worse, or simply due to greater awareness about drug safety issues.

The watchdog group that prepared the analysis has served hospitals and pharmacists for years as a clearinghouse for information on medication errors. Known as ISMP, the organization is now trying to reach consumers with regular reports on drug safety trends.

"We believe that one of the most important tools to promote is to monitor trends on a regular basis," said Thomas J. Moore, a senior scientist with ISMP. "Knowing which drugs are causing injuries and how many people are being hurt is the raw material we need to fashion sound measures to promote patient safety."

The FDA defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy. The agency's monitoring system relies on voluntary reports from doctors and is only believed to capture a fraction of overall problems.

The 20,745 cases reported from January through March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said.

The number of deaths, 4,824, was a nearly threefold increase from the last calendar quarter of 2007. The FDA said heparin was largely to blame.

Previous ISMP research has shown that reports of serious drug safety problems had increased markedly since the late 1990s.

The FDA case reports provide a signal of possible problems with a drug, but a cause-and-effect connection can only be established through painstaking investigation. If the FDA were a police agency, the reports would indicate "probable cause," but not necessarily "guilt beyond a reasonable doubt."

The ISMP study found that heparin accounted for 779 reports of serious problems, including 102 deaths. The FDA, using data that covers a longer time period, has reported 238 deaths possibly linked to heparin.

Heparin "illustrates an example of a significant drug safety problem that was promptly and effectively resolved by the drug manufacturers and the FDA once the issue was detected and understood," the report said.

Not so with Chantix, it concluded.

The FDA should forcefully warn patients taking Chantix that they may have blackouts that could lead to accidents, the report said. Current warnings say patients may be too impaired to drive or operate heavy machinery, but such language is standard for many medications. The government has banned the drug for pilots.

The report found 15 cases of Chantix patients who appeared to have been involved in traffic accidents, and 52 additional cases involving blackouts or loss of consciousness. The FDA said it taking a second look at the Chantix warnings.

The agency received 1,001 reports of serious injuries linked to Chantix, more than for the 10 best-selling brand name drugs combined.

Chantix "continued to provide a striking signal of safety issues that require investigation and action," the report said. The authors acknowledged Pfizer's concern that publicity may be driving up the number of reports, but concluded there's enough evidence to warrant stronger FDA action.

Pfizer said the total sum of its Chantix data, including results from clinical trials, show the drug's benefits clearly outweigh its risks.

"We stand by the efficacy and safety profile of Chantix," the company said in a statement. "There are few things that provide greater health benefits than quitting smoking. Pfizer is committed to reducing the prevalence of smoking globally. As part of that mission, we want to increase peoples' understanding of the dangers of smoking and the benefits of quitting."

But then again we've mentioned Chantix in several other posts herein.
And if you've queries regarding more natural ways to approach stopping smoking, contact us.