QUESTIONS ABOUT CHOLESTEROL LOWERING DRUGS

In the interest of transparency, I must reveal that I have extremely high cholesterol in my blood and a family background of cardiovascular disease. My doctors have all prescribed cholesterol lowering drugs. I have been through every one of them on the market starting with niacin and each time, within three days, I have become a victim of severe muscle aches. That is one of the signs of serious and even fatal side-effects of such drugs.

Recently, while researching material for the updates of my seventh editions of A Consumer’s Dictionary of Food Additives and A Consumer’s Dictionary of Cosmetic Ingredients, I was looking through the FDA’s Medwatch Safety Alerts for Human Medical Products.

I found several describing side-effects from these multi-billion dollar medications in the category. Here they are:

Simvastatin Used With Amiodarone

Audience: Cardiologic healthcare professionals, pharmacists, other healthcare professionals

FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone, (Crodarone®) a medication to keep the heart beating in sync. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.

Statin drugs and amyotrophic lateral sclerosis (ALS)

Audience: Neurologists, cardiologists, consumers
[Posted 09/30/2008] An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The FDA analysis was undertaken after the agency received a higher than expected number of reports of ALS patients on statins. It is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with those given a placebo.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.


Ezetimibe/Simvastatin (marketed as Vytorin)
Simvastatin (marketed as Zocor)
Ezetimibe (marketed as Zetia)

Audience: Endocrinologists, cardiologists, other healthcare professionals, patients
FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the 5-year study.
FDA anticipates receiving a final SEAS study report in about 3 months and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency.


It has been reported recently the incidence of heart disease and stroke have dropped significantly in recent years. Many credit it to the use of cholesterol lowering drugs. Others say, “What about the drop in cigarette smoking, a known culprit in cardiovascular disease? Could that be responsible for the good news and not the drugs?

There have been many negative cholesterol drug reports popping up periodically without much fanfare. For example, with the multi-billion dollar powerful drug Crestor was reported to be “ significantly more likely than other statins to cause muscle deterioration that can lead to kidney disease and failure” according to a study in the American Heart Association's journal, Circulation.

Documents on the FDA website reveal that pharmaceutical companies Merck and Schering-Plough conducted numerous safety studies on the popular cholesterol drug Zetia but did not publish the results, which suggested that the drug may cause liver damage when mixed with statins.

Zetia is a trade name for the drug, ezetimibe, also marketed under the names Ezetrol and Ezemibe. It is a major seller for Merck and Schering, and is estimated to have earned them $5 billion in 2007.

The website http:// www.naturalnews.com explained the Zetia blocks cholesterol absorption in the gut, and is often prescribed in conjunction with another class of cholesterol drugs, called statins. Because statins function in a different fashion by increasing the rate at which LDL cholesterol is cleared from the blood, the combination leads to a greater overall decrease in cholesterol levels. This combination is so popular that Merck and Schering also sell a combination Zetia-Zocor (simvastatin) pill under the brand names Vytorin and Inegy.

But concerns have long existed that the combination of Zetia and statins may lead to liver damage. As early as 2002, an FDA reviewer recommended against allowing the drugs to be mixed, due to liver damage in animal studies. Since the drug's approval, various case studies of liver damage have been published in medical journals.

It may be that the statins are life-safer for the majority of users. But then, again, with the money behind promoting them, they may not be as good as publicity promotes.


Statins currently available in the U.S.include:

* Atorvastatin (Lipitor®)
* Fluvastatin (Lescol®)
* Lovastatin (Mevacor®, Altoprev™)
* Pravastatin (Pravachol®)
* Rosuvastatin Calcium (Crestor®)
* Simvastatin (Zocor®)

To make up your own mind, it might help if you followed the FDA’s http://www.fda.gov/medwatch/safety/ as well as some cynical sites such as http://naturalnews.com. I, of course, will alert you when I am able, to what is happening backstage.

STEM CELLS AND WRINKLES

Now that the cosmetics industry has helped us to make us obsessed with wrinkles, can their scientists give us products that do more than peel or puff the outer layer of skins and get rid of those outward signs of aging?

For at least ten years since I’ve been following the efforts to harness stem cells for anti-aging-skin products. Unspecialized stem cells are like chameleons with the ability to grow into any one of the body's more than 200 cell types. Scientists are searching for ways to cultivate stem cells into specific tissues or substances that could be used to treat a variety of illnesses from cancer to heart disease and Alzheimer’s. They believe eventually, such cells may be manipulated into liver, bone, skin cells or other tissues to replace missing, defective or diseased tissue. Stem cell research, however, has faced a political quagmire because stem cells seem to be most potent in the tissue of developing fetuses. The Right To Lifers and others were horrified that such cells might be taken from aborted fetuses or from in embryos grown in a Petri dish---even to help save a human life. How would they react if they knew that stem would be just used for vanity purposes?

In an effort to find other non-controversial ways of obtaining useful stem cells, researchers reported they could get such stem cells from cast off umbilical cords after birth and from other cells in the adult body including skin cells. Progress has been slow in the world of human medicine because of opposition and lack of funding but in the laboratories of cosmetic companies, the chase is on to find anti-aging stem cells. The idea is to fight wrinkles with stem cells that would correct diminishing elastin and collagen.

Elastin is a protein in connective tissue. It is now used in hair and skin products as a moisturizer and conditioner. Collagen is also a protein found in connective tissue. It is elastin and collagen in the skin that undergo changes from aging and over exposure to the sun which contribute to the appearance of wrinkles and outward signs of aging. Both now used in cosmetics are derived from animal tissue.

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A Salt Lake City company released its product, Amatokin, at Bloomingdale's last year with the advertising slogan "Stem Cells: The future of skin rejuvenation." The price--- $190 for a 30-milliliter tube - about 1 ounce. Are the stem cells in the product able to actively reproduce elastin and collagen cells in the skin?

PhytoCellTecTM Mallus Domestica of Mibelle Biochemistry announced in October that “for the first time the potential of stem cells for skin rejuvenation is evident”. The company claims “Only stem cells are indispensable for tissue regeneration. Only stem cells can produce new tissue cells. Because the terminally differentiated cells in the epidermis are shed from the skin there must be a continuous delivery.”

The manufacturer says it stem cell products may not only fight wrinkles, it can help keep hair from aging and protect the skin against the sun. Cosmetic companies are known to manipulate the truth but PhytoCellTec TM Mallus Domestica definitely has stem cells in their product. Their compound is derived from cultured Mallus Domestica--apple stem cells.

ABOUT FOOD ADDITIVES AND GOOD BACTERIA

By Ruth Winter, MS



We have all heard about the evil bacteria that contaminate our meat and spinach and other edibles we may ingest but can there be good bacteria deliberately added to our food? The answer is “yes” and I’ve been giving some to myself and my family for years. The beneficial ones are called probiotics--- a word compounded from Latin and a Greek meaning "favorable to life.”
The World Health Organization defines probiotics as "live microorganisms that when administered in adequate amounts confer a health benefit on the on the host." The idea that friendly bacteria in yogurt, for example, can crowd out pathogenic organisms was originally purported by Russian-French bacteriologist Ilya Metchnikoff in The Prolongation of Life published in 1907.
Today, most products contain bacteria isolated from milk products and typically contain species of Lactobacillus or Bifidobacterium, both of which I have used in powdered or pill form. Now, more and more live micro-organisms are being added to food or added to animal feed. They are considered "friendly germs," due to their ability to help restore microbial balance in the intestine and in the immune system. In addition to lactobacilli, bifidobacteria, streptococci, and some yeasts and molds--alone or as mixtures-- are now direct food additives.
In marketing probiotics, companies either make health claims based on their own research or refer to the wide range of studies conducted with various probiotic strains. Many studies have shown that probiotics may, indeed, boost the immune system. A recent investigation reported by Dr. Mark Besselink of Utrecht University Medical Center in the Netherlands in the journal Surgery described 14 randomized-controlled trials on the use of probiotics. The friendly bacteria were given to patients undergoing abdominal surgery, liver transplantation or severe trauma. Nine showed a significant decrease in infectious complications causing Dr. Besselink to say he was “enthusiastic about preoperative probiotics." In another study published in 2008 in the British Journal of Sports Medicine, probiotic supplements were found to reduce the number and length of infections suffered by long-distance runners. Strenuous training can affect the immune system and make athletes vulnerable to coughs and colds. The study conducted in Australia found taking probiotics more than halved the days the athletes had symptoms. In another clinical study published in The British Medical Journal, 113 patients had been hospitalized and given antibiotics. A follow-up after discharge showed the group taking probiotic drinks fared much better. Only 12% of those people developed antibiotic-associated diarrhea compared to 34% of the ex-patients not taking probiotics.
The belief is that when administered orally, Lactobacillus rhamnosus GG adheres to the mucous membrane of the intestines and helps restore the balance of the gastrointestinal (GI) microflora; promote gut-barrier functions; diminish the production of cancer-causing compounds by other intestinal bacteria; and activate the innate immune response and enhance adaptive immunity, especially during infections.
Scientific understanding of probiotics and their potential for preventing and treating health conditions is still in an early stage, despite the fact that probiotic have been used in folk medicine for many years. Traditional medicine practioners are now paying attention to the “friendly bacteria”. A conference co-funded by the US National Center for Complementary and Alternative Medicine (NCCAM) and convened by the American Society for Microbiology explored this topic. According to the conference report, there is encouraging evidence shown by scientific studies for some uses of probiotics. They are as follows:

• To treat diarrhea (this is the strongest area of evidence, especially for diarrhea from rotavirus)


• To prevent and treat infections of the urinary tract or female genital tract


• To treat irritable bowel syndrome


• To reduce recurrence of bladder cancer


• To shorten how long an intestinal infection lasts that is caused by a bacterium called Clostridium difficile


• To prevent and treat pouchitis (a condition that can follow surgery to remove the colon)


• To prevent and manage atopic dermatitis (eczema) in children

Some preliminary studies cited by researcher at the NCCAM Conference also report that certain probiotics can play a role in reducing the development of allergy in children. They also reported the apparent ability of probiotics to decrease Helicobacter pylori colonization in the stomach (which produces ulcers); help patients cope with side effects of antibiotic therapy; manage relapse of some inflammatory bowel conditions; lower the risk of certain cancers; decrease dental-caries-causing microbes in the mouth, and keep healthy people healthy.
The conference panel, in addition noted that in studies of probiotics as cures or any beneficial effect was usually low; a strong placebo effect often occurs; and more research (especially in the form of large, carefully designed clinical trials) is needed in order to draw firmer conclusions. Such research has started. For example:

• At the Mayo Clinic College of Medicine, researchers have been examining probiotics for possibly decreasing the levels of certain substances in the urine that can cause problems such as kidney stones.


• A team at Tufts-New England Medical Center is studying probiotics for treating an antibiotic-resistant type of bacteria that causes severe infections in people who are hospitalized, live in nursing homes, or have weakened immune systems.
• Researchers at Tufts University are conducting a preliminary study on whether yogurt has the potential to reduce growth problems related to diarrhea and malnutrition in weaning infants.

• An Ohio State University team is studying whether Lactobacillus could potentially boost infants' immune systems and help ward off diarrhea-causing infections.


• Researchers at the Johns Hopkins University are investigating whether probiotics could have a role in treating fatty liver disease (a chronic condition in which fat accumulates in the liver).


Among the many questions yet to be answered are:

• Exactly how do probiotics interact with the body (such as the gut and its bacteria) to prevent and treat diseases and will new technology in medicine find the answers?


• How really viable and effective are probiotic bacteria after being added to food?


• What are the most effective ways to administer probiotics for therapeutic purposes, as well as the best doses and schedules?


• What is the potential of probiotics to help with the problem of antibiotic-resistant bacteria in the gut?


• Can probiotics prevent unfriendly bacteria from getting through the skin or mucous membranes and traveling through the body such in cases of patients suffering burns, shock, trauma, or suppressed immunity?

What about side-effects? Some live microorganisms have a long history of use as probiotics without causing illness in people. Probiotics' safety has not been thoroughly studied scientifically, however. More information is especially needed on how safe they are for young children, elderly people, and people with compromised immune systems. Probiotics' side effects, if they occur, reportedly tend to be mild and digestive such as gas or bloating. More serious effects have been seen in some people. Probiotics, for example, might theoretically cause infections that need to be treated with antibiotics, especially in people with underlying health conditions. They could also cause unhealthy metabolic activities, too much stimulation of the immune system, or gene transfer (insertion of genetic material into a cell).
Probiotic products taken by mouth as a dietary supplement are manufactured and monitored as foods, not drugs. Their quality (e.g., their identity, potency, purity, and shelf life) can vary--even from lot to lot or bottle to bottle. The National Center for Complementary and Alternative Medicine (NCCAM) and the National Institutes of Health are funding research. For more information you can check the US government’s http://nccam.nih.gov/health/probiotics/ and usprobiotic.org (commercially sponsored).

ANTIBIOTICS ON YOUR PLATE

My interest in food safety was first sparked by an allergist saying my little daughter’s seemingly incurable hives might be due to penicillin in the milk.

“What’s penicillin doing in the milk?” I asked. As a reporter, I found that not only was penicillin the milk, it was in poultry, beef and in many of our edibles. My daughter now has a grown daughter of her own and still more than half the antibiotics produced are fed to animals today.

Currently 16 different antimicrobial drugs are approved for use in United State’s poultry production with gentamicin reported to be the most widely used. Our country is not alone in lacing meat and milk with antibiotics.

The Department of Environment, Food & Rural Affairs (Defra) in Britain, for example, just released a study pointing to the growing resistance of specific food pathogens to antimicrobials, drugs used to combat the germs in animals at the production stage. Up to 29 per cent of the Campylobacter, now the leading cause of bacterial food poisoning, are now resistant to commonly used antimicrobials, according to a UK survey.


The report warns processors about the problems of resistant germs being passed along the food chain to consumers. The survey found that cephalosporin, a popular human antibiotic medication, is increasingly ineffective against E. coli. In humans E. coli is one of the two most important bacterial pathogens causing sickness. Over half of the E. coli bacteria isolates tested were resistant to ampicillin or amoxicillin, and up to 19 per cent were resistant to ciprofloxacin. The majority of E. coli O157, one of the most dangerous forms of the pathogen, were found in humans to show resistance to tetracyclines, sulphonamides and streptomycin in some regions.

Health providers and consumers have been widely blamed for overusing antibiotics in human illnesses and thus causing the growing ineffectiveness of antibiotic medicines but poultry workers may be the unknowing culprits. Researchers in the United States have just reported the poultry employees may be spreading antibiotic-resistant bacteria to those who do not work in the sector.

Researchers at the Johns Hopkins Bloomberg School of Public Health found that these workers were 32 times more likely to be carriers of E. coli bacteria resistant to the commonly used antibiotic gentamicin when compared to other employees.

The results, published in a recent edition of Environmental Health Perspectives, suggest that food processing could play a greater role than previously thought in the spread of antibiotic-resistant bacteria.

"One of the major implications of this study is to underscore the importance of the non-hospital environment in the origin of drug resistant infections," said Ellen K. Silbergeld, PhD, senior author of the study. It was noted many of these workers wear uniforms and these could be handled by other household members during laundry who would then be exposed to the bacteria.

The study, which was conducted by the research faculty at the Johns Hopkins School of Medicine, Division of Infectious Disease, concluded: The findings will lend weight to those who are critical of antibiotic use in the poultry sector. Antibiotic resistance has become a serious problem for public health services around the world.”

Ask my daughter. That’s not news to me. Is it to you? Who is going to do something about it? Stay tuned.