A study that was just completed in March, and reported in JAMA showed that fish oil had no benefits in patients who either had heart disease or who were at risk for getting heart disease. Whether or not eating fatty fish twice a week is helpful or not remains to be seen. Yes, high doses of fish oil can lower triglyceride levels but this, too, will not reduce your risk of getting heart disease. However, it is well known that triglyceride levels greater than 500 will increase the risk of acute pancreatitis, which is an extremely painful disease.
As always, please feel free to discuss any and all supplements that you are either using or thinking about using with us. Do not trust your healthcare to the internet, family or friends.
As our patients and readers of the Kaizen Total Wellness blog already know, I have been on this bandwagon for years! Supplements are often useless, not regulated properly, and generally not beneficial!! Much has been written lately confirming my opinions – and the following editorial in the Herald Tribune states it thoroughly and clearly!
A portion of this editorial has been printed here. To read the entire editorial, go to this link:http://www.heraldtribune.com/article/20131227/OPINION/312279997?p=1&tc=pg
Published: Friday, December 27, 2013 at 1:00 a.m.
Last Modified: Thursday, December 26, 2013 at 6:10 p.m.
Dietary supplements, whose makers make health-related claims ranging from mundane to miraculous, are a $32 billion industry in the United States.
Yet, since a deregulation law was passed in 1994 and signed by then-President Bill Clinton, supplements that include potent drugs or fillers largely escape inspection by the Food and Drug Administration — until users become sick or die.
New data — released last month and reported Sunday by the New York Times — suggests that dietary supplements account for nearly 20 percent of drug-related liver injuries in hospitalized patients. That percentage is up from 7 percent a decade ago.
The Times told the story of a 17-year-old Texas boy who had taken a concentrated green tea extract, purchased at a nutrition store and labeled as a “fat burner.” The boy’s liver had sustained so much damage that a transplant was required.
Since the Dietary Supplement Health and Education Act was passed nearly two decades ago, physicians, researchers and the FDA have steadily reported adverse reactions and issued warnings about supplements. For example:
• In November, the Times reported that Canadian researchers used DNA testing to check the ingredients of 44 bottles of popular supplements sold by 12 companies. In one-third of the bottles, the tests showed not a single trace of the herb listed on the bottle label. Others were mixed with filler ingredients not listed on the label.
• In April, U.S. regulators found that “workout-booster” and “fat-burning” products sold as Jack3d and OxyElitePro contained a stimulant called dimethyamyamine (DMAA). The stimulant was linked to heart problems, high blood pressure and at least five deaths (reporting remains sketchy and likely underestimates the problems).
• In 2011, investigators found Pai You Gho — a weight-loss supplement from China that contained two drugs, including a suspected carcinogen — on store shelves, even though the product was recalled in 2009.
• In 2009, the FDA issued a public warning about the “Xtreme” line of body-building products, which improperly contained synthetic steroids. StarCaps, made in Peru and promoted as an all-natural weight-loss supplement, was found to contain bumetanide, a potent diuretic. Hydrocut, another supposed fat burner, was recalled after the FDA linked its use to liver and muscle damage and heart problems.
At the time, the FDA warned that 70 brands of pills illegally contained prescription-drug ingredients.
• In 2004, the FDA banned the use of supplements containing ephedra, a class of natural, amphetamine-like substances found in plants. Unfortunately, the ban didn’t occur until after the administration cited “substantial evidence of harm,” based on a study that showed “more than 16,000 adverse events associated with the use of ephedra-containing dietary supplements, including heart palpitations, tremors and insomnia.”
The dangers of such products made national headlines in February 2003 when a Major League Baseball player — attempting to lose weight during spring training — died after using ephedra three times per day. (Ironically, after 2004, Hydroxycut created a whole line of “ephedra-free” products.)
For the rest of the editorial, you can find it in the Dec. 27, 2013 edition of the Herald Tribune or click on this link:
Reproduced from Dece,ber 14, 2013 article in New York Times su
By PAUL A. OFFIT and SARAH ERUSH
Paul A. Offit is chief of the division of infectious diseases at the Children’s Hospital of Philadelphia, where Sarah Erush is the clinical manager in the pharmacy department.
December 14, 2013
PHILADELPHIA — PARENTS whose children are admitted to our hospital occasionally bring along something extra to help with their care: dietary supplements, like St. John’s wort to ameliorate mild depression or probiotics for better health.
Here’s the problem: The Joint Commission, which is responsible for hospital accreditation in the United States, requires that dietary supplements be treated like drugs. It makes sense: Vitamins, amino acids, herbs, minerals and other botanicals have pharmacological effects. So they are drugs.
But the Food and Drug Administration doesn’t regulate dietary supplements as drugs — they aren’t tested for safety and efficacy before they’re sold. Many aren’t made according to minimal standards of manufacturing (the F.D.A. has even found some of the facilities where supplements are made to be contaminated with rodent feces and urine). And many are mislabeled, accidentally or intentionally. They often aren’t what they say they are. For example:
In 2003, researchers tested “ayurvedic” remedies from health food stores throughout Boston. They found that 20 percent contained potentially harmful levels of lead, mercury or arsenic.
In 2008, two products were pulled off the market because they were found to contain around 200 times more selenium (an element that some believe can help prevent cancer) than their labels said. People who ingested these products developed hair loss, muscle cramps, diarrhea, joint pain, fatigue and blisters.
Last summer, vitamins and minerals made by Purity First Health Products in Farmingdale, N.Y., were found to contain two powerful anabolic steroids. Some of the women who took them developed masculinizing symptoms like lower voices and fewer menstrual periods.
Last month, researchers in Ontario found that popular herbal products like those labeled St. John’s wort and ginkgo biloba often contained completely different herbs or contaminants, some of which could be quite dangerous.
The F.D.A. estimates that approximately 50,000 adverse reactions to dietary supplements occur every year. And yet few consumers know this.
Parents of children admitted to our hospital often request that we continue treating their child with dietary supplements because they believe in them, even if that belief isn’t supported by evidence. More disturbing were the times when children were taking these supplements without our knowledge. Doctors always ask parents if their children are taking any medicines. Unfortunately, because most parents don’t consider dietary supplements to be drugs, we often never knew about their use, let alone whether they might react dangerously with the child’s other treatments.
The F.D.A. has the mandate, but not the manpower, to oversee the labeling and manufacture of these supplements. In the meantime, doctors — and consumers — are on their own.
Our hospital has acted to protect the safety of our patients. No longer will we administer dietary supplements unless the manufacturer provides a third-party written guarantee that the product is made under the F.D.A.’s “good manufacturing practice” (G.M.P.) conditions, as well as a Certificate of Analysis (C.O.A.) assuring that what is written on the label is what’s in the bottle.
The good news is that we’ve been able to find some vitamins, amino acids, minerals and a handful of other supplements that meet this standard. For example, melatonin has been shown to affect sleep cycles and has a record of safety, and we identified a product that met manufacturing and labeling standards.
The bad news is that this was a vanishingly small percentage of the total group. Around 90 percent of the companies we reached out to for verification never responded. They didn’t call us back, or their email or manufacturing addresses changed overnight. Of the remainder, many manufacturers refused to provide us with either a statement of G.M.P. or a C.O.A.; in other words, they refused to guarantee that their products were what they said they were. Others lied; they said they met G.M.P. standards, but a call to the F.D.A. revealed they had been fined for violations multiple times. Perhaps most surprising, some manufacturers willingly furnished information that their product didn’t meet standards — like one company that provided a C.O.A. showing that its product contained 47,000 International Units of beta-carotene, when the label stated 25,000.
Now, when parents in our hospital still want to use products whose quality can’t be assured, we ask them to sign a waiver stating that the supplement may be dangerous, and that most have not been studied for their effectiveness. “Use of an agent for which there are no reliable data on toxicity and drug interactions,” the waiver reads, “makes it impossible to adequately monitor the patient’s acute condition or safely administer medications.”
What can other individuals who are concerned about supplement safety do? They can look for “U.S.P. Verified” on the label — this proves the supplement has been inspected and approved under the United States Pharmacopeial Convention. Unfortunately, fewer than 1 percent of the 55,000 or so supplements on the market bear this label. The real answer is that, until the day comes when medical studies prove that these supplements have legitimate benefits, and until the F.D.A. has the political backing and resources to regulate them like drugs, individuals should simply steer clear.
For too long, too many people have believed that dietary supplements can only help and never hurt. Increasingly, it’s clear that this belief is a false one.
Americans spend $5 billion/year on unproven herbal supplements. But now, there’s a new twist: DNA tests show that most herbs contain little more than powdered rice and weeds! Canadian researchers tested 44 bottles of popular supplements and found that most were either diluted or replaced by rice and weeds. The specimens were bought from retail stores in both the USA and Canada! Under a 1944 law, supplements may be sold with little regulatory oversight.
I’m not sure what is more disturbing: the public’s faith in supplements or their LACK of faith in their physicians.