Vol. 134 October 15, 2015 Supplements Are Not Harmless.

October 16, 2015

Hub thumbnail 2015

“The belief is that they [dietary supplements] are entirely safe,
but now science says that they’re not.”
– Pieter Cohen, MD, Harvard Medical School

A recent study of 63 hospitals from 2004 to 2013 estimated that over 20,000 ER visits and 2000 hospital admissions annually in the U.S. were due to adverse effects of dietary supplements. Adverse events included allergic reactions, excess doses, unsupervised ingestion by children, or other events (e.g., choking). Cases involving death, intentional self-harm, drug abuse, or withdrawal were excluded.  Adverse effects commonly involved cardiovascular adverse effects from weight-loss or energy herbal products among young adults, unsupervised ingestion of micronutrients (iron) by children, and swallowing problems associated with micronutrients (multi-vitamins) among older adults. (1)

The supplements listed included orally administered herbal products (Echinacea, Coenzyme Q10, Gripe Water, etc.), complementary nutritional products (fish oil, body building protein , chondroitin/glucosamine, etc), vitamins and minerals (including calcium and iron), and topically administered herbal or homeopathic products. Energy drinks and herbal tea beverages were excluded from the study.

In the U.S. there were more than 55,000 dietary supplements on the market in 2012, and about half of all adults reported having used at least one dietary supplement in the past month. 150 million people in the U.S. take supplements, including children’s vitamins. In 2007, out-of-pocket expenditures for herbal or complementary nutritional products reached $14.8 billion, which equaled one-third of the total out-of-pocket expenditures for prescription drugs.

  • Weight loss supplements or herbal energy products led the list of supplements with adverse effects in this study.
  • More than half of emergency department visits for supplement-related adverse events involved female patients.
  • Sexual-enhancement products or bodybuilding products were implicated in 14% of emergency department visits for supplement-related adverse events among male patients; there were too few cases among female patients to calculate a reliable estimate.
  • 20% of ER visits involved children who took supplements without supervision.
  • Most ER visits for unsupervised ingestion of supplements by children involved multivitamins (34%), iron (12%), supplements for weight loss (11%), and supplements for sleep, sedation, or anxiety (9%). Child-resistant packaging is not required for dietary supplements other than those containing iron (the amount of iron in the usual bottle can be lethal to small children) , but despite such packaging, iron supplements were the second most commonly implicated type of supplement in unsupervised ingestion by children.

Although the numbers of ER visits and hospitalizations were less than the 5% of the ER visits that have been reported for pharmaceutical products, dietary supplements are unregulated and marketed under the presumption of safety. The FDA is actually BARRED from regulating dietary supplements by the Dietary Supplement Health and Education Act of 1994. (Wouldn’t you like to know the history of that particular bill, or at least, the lobbyists involved?)

When you or someone you know has a good effect from a supplement (like taking glucosamine for knee pain) it natural to think that anyone with knee pain should take it, and that every physician should know about this “miracle supplement”. In medicine that kind of anecdote is called a “case report”.  Case reports can lead to studies of a large number of people, called “statistical studies”. Results of those studies can be persuasive, but the truly scientifically skeptical physician will wait for the results of an organized, randomized, double-blind study with controls (people who don’t get the supplement). Such organized, controlled studies have not found a whole lot of benefit, if any, from taking dietary supplements, especially vitamins, but that is the subject for another whole blog… or two.

References;

1. Emergency Department Visits for Adverse Events Related to Dietary Supplements
Andrew I. Geller, M.D., et al, N Engl J Med 2015; 373: 1531-1540; October 15, 2015


Vol. 74 September 15, 2012 More Surprising Medical Fun Facts

September 15, 2012

An 11 year study of 41,000 adult Spaniards showed no association between consumption of food fried in olive oil or sunflower oil and deaths from heart attacks. (1)

More than 10,000 events of non-trivial bleeding (intestinal bleeding, stroke, nose bleeds, and blood in the urine) occurred in 102,000 study participants who did NOT have heart disease BUT who were taking daily aspirin in hopes of preventing fatal heart attacks. Their death rate from heart attack was NOT reduced. (2)

Eating only organic food made very little difference in the health of individuals according to a Stanford University review of 237 studies (a “Meta-analysis”). Organic produce had a 30% reduction in detectable levels of pesticides compared to standard produce. If uncooked organic meat harbored bacteria, those bacteria were 33% less apt to be resistant to multiple antibiotics compared to uncooked non-organic meat. (3)

More than 6300 reports of serious adverse events associated with vitamins, herbs, and other dietary supplements were filed with the FDA from 2007 to mid-April 2012. (The FDA expects 8,160 to be filed by dietary supplement companies in the next three years.)
The FDA has banned only one ingredient, ephedrine alkaloids (ephedra), used in weight loss supplements and implicated in a number of deaths. That took 10 years to do.
The only ingredient in supplements that requires an FDA warning label about adverse effects is iron, because accidental overdosing in children can be fatal. Labeling of potential adverse side effects and/or interactions with other drugs or supplements is extremely inconsistent.(4)
Check out this website for a guide to over 100 dietary supplements: Consumer Reports-Natural Health.

30% of the water consumed in Singapore is recycled sewage water called NEWater. The public accepted it only after a massive public educational campaign and the decision to release the NEWater only by mixing it in with the water in regular reservoirs. (5) Recycled sewage water may soon by on sale in the U.S. under the name “Porcelain Spring”, using Jack Black as it’s celebrity promoter. For other striking facts about the growing water shortage in Las Vegas, parts of California, and a shrinking Lake Mead behind the Hoover Dam check out the movie, “Last Call at the Oasis.

Factor by which the number of American babies born addicted to opiates has increased since 2000:  3
Number of private U.S. citizens killed in terrorist attacks in 2010:   15
Number of U.S. citizens killed by falling TV sets in 2010:   16    (6)

% change in average retail price for drugs from 2007 to 2012 and 2012 cost per prescription:
Crestor (statin) +91%               $214         generic in 7/2016
Lipitor (statin)  +87%                $237      generic available
Plavix (anticoagulant) +84%   $261      generic available
Boniva (osteporosis)  +102%    $240     generic available
Singulair (asthma)  +72%        $205      generic available
Provigil (sleepiness)  +305%   $1,101   generic available   (7)

The rate of infants born to adolescents aged 15-17 years dropped in 2012 from 20 to 17 per 1000.
The percentage of children under the age of 6 years living in a home with a smoker decreased from 15% in 2005 to 10% in 2012.
The percentage of children living in counties with air pollutants above allowable levels increased from 59% to 67%. (8)

In the mid-60’s each patient discharged alive from Massachusetts General Hospital “cost” about $4,000. In 2002 that “cost” was over $25,000 per patient.
Since 2001 the mortality rate of patients hospitalized at MGH has been stable at about 2% “but the cost per patient has escalated dramatically”. This period seems to be characterized by “diminishing returns with growth in costs far outpacing reductions in inpatient mortality”.(9)

References:
1. BMJ 2012 Jan. 24 :344
2.“Aspirin: To use or not to use?” Arch Intern Med 2012 Feb 13; 172
3. Ann Int Med reported in Bos Glob Sept. 4, 2012
4. Consumer Reports September 2012
5.Wired Sep 2012 p.32
6. Harper’s Index June 2012
7. Consumer Reports on Health Sept. 2012
8. Reported in Journal Watch Pediatrics Sept. 2012 
9. N Engl J Med 366:23 June 7, 2012


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