Enough Is Enough: Stop Wasting Money on Vitamin and Mineral Supplements Free

Irvine Mason, MD

Neurology and Pain Management of the Palm Beaches

December 19, 2013

Enough is Enough

This letter is in response to your recent editorial stating there was no benefit from taking vitamins or mineral supplements.  The authors purported their opinions were as facts.  They stated  that most supplements “do not prevent chronic disease or death, and they should be avoided.”

The authors totally disregarded the best and most comprehensive study to date, The physicians healthy study II published in the American Medical Association, November 2, 2012.  That study followed nearly 15,000 male doctors older than 50 for up to 13 years.  The study revealed that men taking centrum silver multivitamin alone reduced the risk of cancer by over 8% from any source except prostate.  I quote from the above study, “recent studies have looked at vitamins such as B, C, E and whether they can prevent cancer.  They didn’t come up with any significant results, and some found a higher risk of certain illnesses.  The researchers state that those studies were limited in scope and size.  They also used single supplements at high doses, compared to how much a daily vitamin provides.”

The physicians health study II is the only large scale, randomized double blind, placebo-controlled trial testing the long term effects of common multi-vitamins.

If the authors are correct in their assumptions then every ophthalmologist in the free world who prescribes anti-oxidant vitamins with lutein to treat macular-degeneration is wrong.  If  the authors are correct then every OB/GYN in the free world who prescribe prenatal vitamins to prevent spina-bifida, meningomylocele and other neural-tube defects in the neonate are wrong.  This regimen is factual and proven.  If the authors are correct the the vast majority of urologists that prescribe time release vitamin C to their patients for recurrent UTI’s are wrong.  This protocol obviates the need for chronic antibiotic use, which creates drug resisitant bacterial strains.  Bacteria have a very difficult time living in a acid environment ergo the vitamin C.

If the authors are correct then another excellent study dated May 20, 2013 out of Oxford University is wrong.  “…the subject of the latest research study showed that   vitamin B (B6, B12, folic acid) is the first and only disease-modifying treatment that worked”.   The study stated, “we have proven the concept that you can modify the disease”.  The study showed that there was slowing of atrophy of the gray matter in the brain effected by Alzheimer’s disease.

This was a doubleblinded study of two years of duration which, discovered that the brain shrinkage slowed by 30%, and in some cases brain shrinkage slowed by more than 50%.

How do you know that your antioxidant vitamins are working?  Your hair and nails will grow at a very rapid rate.  Rapid cell turnover is what your body needs; it prevents GI cancers, which are activated by cell stagnation.  Also rapid turnover of skin cells help prevent skin cancers.

I recommend to the authors that they be thought a fool rather than to put it in print and remove all doubt.  I recommend to the patients that if they find a doctor who states that one receives all the vitamins and minerals from the food they eat, they should find another doctor.

Enough is enough!!!

Irvine Mason, M.D.

Board Certified Neurologist

IM/lm

Deborah Stepp, RN

N/A

December 26, 2013

In response

My concern about the article questioning the usefulness of multivitamins is actually about the way it was presented in the press. I believe, there is a rather large set of individuals who should be taking their vitamins, that would be pregnant women. Any woman of childbearing age should be taking vitamins, as a matter of fact, as we don't always know if we will become pregnant, even if we use protection. Here's one abstract: http://www.ncbi.nlm.nih.gov/pubmed/12163692
This problem was not addressed in the editorial. My concern is that if there is even one woman of reproductive age who may stop taking her multivitamin, to the detriment of any fetus she may be carrying.

Thomas R. Friberg MS,MD

University of Pittsburgh, Pittsburgh, Pa

December 27, 2013

Conflict of Interest: Principal Investigator Age-Related Eye Disease Study (AREDS) Past consultant to Pfizer regarding Age-Related Macular Degeneration

Blinded by erudition?

Blinded by erudition?


The authors of “Enough is enough” (1) declare that vitamin and mineral supplementation in well-nourished adults is pointless in the prevention of “chronic disease.” They neglect to mention the favorable effect that daily multi-vitamins and minerals have on cataract formation as demonstrated a large randomized controlled trial by Physicians Health Study (PHS) II (2). More importantly, they make no mention of the effectiveness of vitamin and mineral supplementation in the prevention of severe visual loss and blindness from age-related macular degeneration, (3,4) a common chronic disease of considerable importance.

Blindness is a most feared disability and is linked strongly to increased mortality, rates of hospitalization, and length of hospital stays. Despite its impact on a patient’s well-being, blindness is often omitted from the problem list during hospital stays(5). It is not so surprising then that one of the principal reasons for vitamin supplementation among older adults, ocular health, was omitted from their editorial.

As a Principal Investigator in both the original Age-Related Eye Disease Study (AREDS) and for the follow-up trial AREDS II, I have seen the role of supplements for the prevention of visual loss in age-related macular degeneration become well established. Unfortunately, these authors were apparently oblivious to needs of patients afflicted with AMD, the most common cause of blindness in adult Americans.


1. Guallar E, Stranges S, Mulrow C, Appei LJ, Miller ER III. Enough is enough: Stop wasting money on vitamin and mineral supplements. Ann Intern Med. 2013; 159:850-851.
2. Christen WG, Glynn RJ, Manson JE, Macfadyen J, Bubes V, Schvartz M, Buring JE, Sesso HD, Michael Gaziano J. A Multivitamin Supplement and Cataract and Age-Related Macular Degeneration in a Randomized Trial of Male Physicians. Ophthalmology. 2013; Nov 20. pii: S0161-6420(13)00883-X. doi: 10.1016/j.ophtha.2013.09.038. [Epub ahead of print]
3. The Age-Related Eye Disease Study Research Group: A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss. AREDS Report #8. Arch Ophthal. 2001;119:1417-1436.
4. Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA. 2013; 15; 309(19):2005-2015.
5. Crewe JM, Morlet N, Morgan WH, Spilsbury K, Mukhtar AS, Clark A, Semmens JB. Mortality and hospital morbidity of working-age blind. Br J Ophthalmol. 2013; 97(12):1579-1585.


Principal Investigator Age-Related Eye Disease Study (AREDS)
Principal Investigator AREDS 2
Past consultant to Pfizer regarding Age-Related Macular Degeneration

Jessica Fargnoli; MPH, Joyce Greenleaf, MBA; Melissa Hafner, MPP

Department of Health and Human Services, Boston, MA

January 3, 2014

More reasons to be wary of supplements

In their editorial, Guallar and colleagues (1) draw attention to mounting evidence that most vitamin and mineral supplements are not beneficial for chronic disease prevention and in some cases may be harmful. We share the authors’ concerns and have released two related reports (2,3) that further highlight risks of dietary supplements based on our review of their labels. Manufacturers make claims on these labels that the Food and Drug Administration (FDA) has limited authority to review; however, consumers rely on those claims in purchasing supplements.

In the first report, we found that claims made on dietary supplement labels may be misleading. Specifically, we reviewed the substantiation for structure/function claims found in a sample of supplements marketed for weight loss and immune support. FDA requires that supplement manufacturers have substantiation to support such claims on their products’ labels. FDA has also issued guidance on the scientific support necessary to substantiate these claims. The substantiation for structure/function claims was not consistent with FDA recommendations that evidence be derived from high-quality human studies. Most studies we reviewed did not involve the actual supplement or test the supplement or its active ingredients in humans. Furthermore, 20% of the supplements’ labels bore claims that are prohibited by FDA, such as disease claims.

In the second report, we found that FDA may have difficulty locating dietary supplement companies in emergencies related to their products. We contacted the companies responsible for the supplements in our sample and found that 28% had facilities that failed to register with FDA as required. Of those that did register, 72% had incomplete or inaccurate contact information. And 20% of sample labels lacked the required contact information for adverse event reporting.

Based on our research, we share the authors’ view that consumers should be wary of dietary supplements’ claims of effectiveness and call on FDA to seek explicit authority to review those claims. Furthermore, FDA should improve the accuracy of its registry to ensure it can respond to a public health emergency related to dietary supplements.



1. Guallar E, Stranges S, Mulrow C, Appel LJ, Miller ER III. Enough Is Enough: Stop Wasting Money on Vitamin and Mineral Supplements. Ann Intern Med. 2013; 159(12):850-851.
2. Office of Inspector General. Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements. Washington (DC): Department of Health and Human Services (US); 2012 Oct. 27 p. Report No.: OEI-01-11-00210.
3. Office of Inspector General. Dietary Supplements: Companies May be Difficult to Locate in an Emergency. Washington (DC): Department of Health and Human Services (US); 2012 Oct. 18 p. Report No.: OEI-01-11-00211.

Balz Frei, PhD, Bruce N. Ames, PhD, Jeffrey Blumberg, PhD, Walter C. Willett, MD

Oregon State Universtiy

February 6, 2014

Enough is enough: Time to consider all the data and avoid sweeping conclusions about vitamin and mineral supplements

In their editorial, Guallar et al. concluded “the case is closed––supplementing the diet of well-nourished adults with (most) mineral or vitamin supplements has no clear benefit and might even be harmful” (1). However, the authors ignored decades of nutrition research and diet monitoring of the U.S. population to reach this misleading conclusion.

While a well-balanced diet is the best way to get one’s essential nutrients (except vitamin D), very few people in the U.S. follow the Dietary Guidelines for Americans. Consequently, most Americans are not “well-nourished” and fall short of meeting the recommendations by the Institute of Medicine for the dietary intake of all vitamins and essential minerals: Over 93% of U.S. adults do not get the Estimated Average Requirement of vitamins D and E from their diet, including enriched and fortified foods; 61% for magnesium; and ~50% for vitamin A and calcium (2). Further, 98% and 71%, respectively, do not meet the Adequate Intake of potassium and vitamin K (2). Many of these percentages are even higher among subpopulations with increased micronutrient needs, including older adults, African-Americans, and the obese. Conversely, people taking a daily multivitamin/mineral supplement (MVM) formulated at about the Daily Value do fill many of these nutritional gaps effectively, safely, and at low cost: a high-quality MVM costs as little as 3 cents a day (https://www.consumerlab.com/) and long-term MVM use is not associated with any adverse health effects (2, 3).

Guallar et al. state that “β-carotene, vitamin E, and possibly high doses of vitamin A supplements increase mortality” (1). Only ~0.1% of U.S. adults exceed the Tolerable Upper Intake Level of vitamin E due to high-dose supplement use, and ~1.1% exceed the UL of vitamin A (2). It is well-known that vitamin A should not be chronically consumed in amounts exceeding the UL because it may cause hypervitaminosis A and birth defects, and smokers should avoid β-carotene supplements because of an increased risk of lung cancer. The meta-analysis of RCTs reporting that high-dose vitamin E supplements increase mortality (1) has been refuted by several, more comprehensive meta-analyses (e.g., 4).

The known biological functions of micronutrients are to maintain normal cell and tissue function, metabolism, growth, and development, e.g., by serving as essential cofactors or structural components of thousands of enzymes and other biomolecules. For example, vitamins A and D, iron, and zinc play critical roles in both innate and adaptive immunity, and folate is required for normal neurological development. An MVM containing folic acid dramatically reduces the risk of neural tube defects and is recommended for women of childbearing age.

MVMs also may help lower chronic disease risk. The largest and longest RCT of an MVM conducted to date, the Physicians’ Health Study II, found a significant 8% reduction in total cancer incidence in male physicians (12% when excluding prostate cancer) and a significant 9% and 13% reduction, respectively, in total and nuclear cataract (3). These findings are consistent with several other RCTs and are even more impressive given that conventional RCT designs have limited ability to reveal benefits of nutrients––in contrast to drugs––for chronic diseases (5).

Therefore, taking a daily MVM not only helps fill known nutritional gaps in the diet of most Americans, thereby assuring normal body function and supporting good health, but may also have the added benefit of helping to reduce the risk of some chronic diseases. To call “the case…closed,” deny the value of further research, and label MVMs useless, harmful, and a waste of money (1) is wrong, not based on the established science for their primary indication, and misinforms both the public and the medical community.

References
1. Guallar E, Stranges S, Mulrow C, Appel LJ, Miller ER III. Enough is enough: Stop wasting money on vitamin and mineral supplements. Ann Intern Med. 2013;159:850-1.
2. Fulgoni VL III, Keast DR, Bailey RL, Dwyer J. Foods, fortificants, and supplements: Where do Americans get their nutrients? J Nutr. 2011;141:1847-54.
3. Gaziano JM, Sesso HD, Christen WG, Bubes V, Smith JP, MacFadyen J, et al. Multivitamins in the prevention of cancer in men. The Physicians' Health Study II Randomized Controlled Trial. JAMA. 2012;308:1871-80.
4. Abner EL, Schmitt FA, Mendiondo MS, Marcum JL, Kryscio RJ. Vitamin E and all-cause mortality: a meta-analysis. Curr Aging Sci. 2011;4:158-70.
5. Blumberg J, Heaney RP, Huncharek M, Scholl T, Stampfer M, Vieth R, et al. Evidence-based criteria in the nutritional context. Nutr Rev. 2010;68:478-84.

 

A.A. Dunham, MA

Hallelujah Acres Health Minister

February 26, 2014

Ridicuous

Regarding this article, even I, not formally trained in medicine, know how to search Pub Med and locate study after study regarding the benefits of vitamins and minerals. I find this article to be ridiculous and potentially injurious to the public.

Suzan L Carmichael, PhD, Carl L Keen, PhD

Stanford University (SC) and University of California, Davis (CK)

March 7, 2014

Enough is Enough – What About Women of Reproductive Age?

We are concerned that the recent editorial “Enough is Enough: Stop Wasting Money on Vitamin and Mineral Supplements” (1) will give the wrong message to a substantial portion of the population – namely, women who are expecting a child or are planning to become pregnant.

The article states, “Although available evidence does not rule out small benefits or harms or large benefits or harms in a small subgroup of the population, we believe that the case is closed – supplementing the diet of well-nourished adults with (most) mineral or vitamin supplements has no clear benefit and might even be harmful.”

In the U.S., women of reproductive age (e.g., 15-44 years) comprise about 24% of the adult population, and 45% of female adults. We hope that the recent commentary will not detract from supplement use in this vulnerable – and substantial – part of the population. Supplement use is particularly important for women “at-risk” of becoming pregnant – i.e., before they become pregnant. Good pre-pregnancy nutritional status is important since over half of all pregnancies are unplanned, and most birth defects occur in the first several weeks of pregnancy, before many women even realize they are pregnant.

The Public Health Service, including the Surgeon General, CDC and FDA (2), and the National Academy of Sciences (3) recommend that women at risk of becoming pregnant take a multivitamin/mineral supplement that contains at least 400 µg of folic acid, primarily to prevent neural tube defects. Supplement use has also been associated with reduced risk of other birth defects and adverse reproductive outcomes. The Teratology Society reiterates its support for the daily intake of vitamin and mineral supplements for women of childbearing age (4).

Suzan L. Carmichael, PhD,1 Carl L. Keen, PhD2

1 Department of Pediatrics, Stanford University
2 Department of Nutrition, University of California, Davis

This comment has been approved by the full Public Affairs Committee and by the Council of the Teratology Society.

References:

1. Guallar E, Stranges S, Mulrow C, Appel LJ, Miller ER. Enough is enough: stop wasting money on vitamin and mineral supplements. Ann Int Med 159:850-851.

2. Centers for Disease Control and Prevention. Recommendations for use of folic acid to reduce number of spina bifida cases and other neural tube defects. JAMA 1993; 269:1233, 1236-1238.

3. Institute of Medicine (US) Standing Committee on the Scientific Evaluation of Dietary Reference Intakes and its Panel on Folate, Other B Vitamins, and Choline. Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline., Washington (DC): National Academies Press (US); 1998.

4. Holmes L, Harris J, Oakley GP Jr, Friedman JM. Teratology Society Consensus Statement on use of folic acid to reduce the risk of birth defects. 1997;55:381.

Edward RB McCabe, MD, PhD, Coleen Boyle, PhD, MSHyg

Senior Vice President and Chief Medical Officer, March of Dimes Foundation and Director, National Center for Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention

March 28, 2014

Enough Is Not Enough for Folic Acid in Women of Childbearing Age

Guallar et al. (1), in their editorial, “Enough Is Enough: Stop Wasting Money on Vitamin and Mineral Supplements,” reviewed three related articles and came to the conclusion their title expressed succinctly. But enough is not enough when it comes to ensuring all women of childbearing age (WCBA) receive sufficient folic acid to prevent neural tube defects (NTDs) in their offspring.

The authors indicate the possibility of benefits “in a small subgroup of the population” (1). The cohort of WCBA (18-44 years) is large; 56 million in 2012.

Failure of the neural tube to close during embryonic development results in NTDs, including spina bifida and anencephaly. Infants with spina bifida have varying levels of paralysis resulting in life-long disabilities, and those with anencephaly generally die shortly after birth. Studies, including randomized, controlled trials, have shown that periconceptional intake of folic acid in adequate amounts prevents NTDs, with observational studies suggesting it might prevent over 50% of NTDs. Since 1998, the Institute of Medicine recommended that to prevent NTDs, WCBA should consume at least 400µg/day of folic acid from dietary supplements or fortified foods, in addition to eating a healthy diet containing natural folates. (2)

In 1995-96, prior to mandatory folic acid fortification of cereal grain flour in the U.S., approximately 4,000 pregnancies were affected with an NTD. This number fell to 3,000 pregnancies for 1999-2000 after fortification (3). Therefore, while NTD reduction has been observed with fortification, important subpopulations of women require more folic acid due to their medical conditions or medications (e.g., treatment with folic acid antagonists), obesity, Hispanic ethnicity, or specific genetic factors (4).

Considerable work needs to be done to promote adequate folic acid supplementation for specific high risk groups to prevent NTDs. For example, the risk of birth defects associated with pregestational diabetes might be reduced by folic acid supplementation (5), and targeting folic acid supplement education efforts to women with pregestational diabetes could be an important prevention strategy.

Guallar et al. (1) stated, “we believe the case is closed – supplementing the diet of well-nourished adults with (most) mineral or vitamin supplements has no clear benefit and might even be harmful.” Such a statement may discourage WCBA from consuming adequate folic acid and may lead to babies born unnecessarily with NTDS. The case is most definitely not closed for these women and their offspring, especially for those groups at the highest risk of NTDs.


References

1. Guallar E, Stranges S, Mulrow C. Enough is enough: stop wasting money on vitamin and mineral supplements. Ann Intern Med. 2013;159:850-1.
2. Institute of Medicine. Dietary reference intakes for thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, pantothenic acid, biotin, and choline. Washington, DC: National Academy Press, 1998.
3. CDC. Spina Bifida and anencephaly before and after folic acid mandate – United States, 1995-1996 and 1999-2000. MMWR. 2004;53:362-5.
4. Kennedy D, Koren G. Identifying women who might benefit from higher doses of folic acid in pregnancy. Can Fam Physician. 2012 Apr;58(4):394-7.
5. Correa A, Gilboa SM, Botto LD, Moore CA, Hobbs CA, Cleves MA, Riehle-Colarusso TJ, Waller DK, Reece EA; National Birth Defects Prevention Study. Lack of periconceptional vitamins or supplements that contain folic acid and diabetes mellitus-associated birth defects. Am J Obstet Gynecol. 2012 Mar;206(3):218.e1-13.

Eliseo Guallar, MD, DrPH, Saverio Stranges, MD, PhD, Cynthia Mulrow, MD, Lawrence J. Appel, MD, MPH, Edgar R. Miller III, MD, PhD

Johns Hopkins, University of Warwick, Annals of Internal Medicine

April 8, 2014

Author's Response

Dr. Frei et al. believe that our current knowledge based on nutritional research and dietary monitoring justifies the daily use of multivitamin / mineral supplements by the majority of Americans. We disagree. In contrast to many prevention strategies, multivitamin, vitamin and mineral supplements are pill-based interventions that are amenable to rigorous evaluation in large scale clinical trials with clinically relevant outcomes. The lack of efficacy and the side effects observed in clinical trials of antioxidant supplements, confirmed once again in a recent Cochrane review (1), should be a constant reminder of our limited ability to infer the consequences of interventions from mechanistic considerations or surrogate endpoints of uncertain clinical relevance.
Dr. Mason and Drs. Frei at al. mention a possible signal of benefit in the Physician’s Health Study II (PHS-II) (2) and the Supplementation in Vitamins and Mineral AntioXidants Study (SU.VI.MAX) (3). The PHS-II was a double-blind, placebo-controlled trial in 14,641 male US physicians. After a median follow-up of 11.2 years, men taking a daily 30-component multivitamin supplement (Centrum Silver) had lower overall cancer incidence compared to placebo (hazard ratio, 0.92; 95% confidence interval [CI], 0.86 – 0.998). The SU.VI.MAX was a double-blind placebo-controlled trial in 13,017 French men and women. After a median follow-up of 7.5 years, there were no major differences in cancer incidence between participants taking a daily 5-component multivitamin supplement and those taking placebo, but a gender-stratified analysis showed a reduced risk of cancer incidence in men taking multivitamins (relative risk, 0.69; 95% CI, 0.53 – 0.91) but not in women (relative risk, 1.04, 95% CI, 0.85 – 1.29). As the observed possible benefits were limited to men, were modest (PHS-II) or evident only in subgroup analyses (SU.VI.MAX), and did not consistently extend to reductions in mortality, these findings are only weak signals compatible with small or no benefit.
As Dr. Stepp indicates, our editorial did not address the use of prenatal vitamin mineral supplements, which is not for chronic use but rather for a limited well-defined period. Our editorial specifically dealt with chronic use of multivitamins. Our editorial also did not address the use of antioxidant vitamins in the treatment of age-related macular degeneration (AMD). There is no evidence that antioxidants or multivitamins prevent or delay the onset of AMD (4), but antioxidants may delay the progression of AMD once it has started (5). Use of antioxidants in this setting, however, should be part of a formal therapeutic plan supervised by an ophthalmologist. Finally, we share the concerns of Drs. Fargnoli et al. on misleading claims on dietary supplement labels and support their call for increased Food and Drug Administration (FDA) authority to review such claims.

Eliseo Guallar, MD, DrPH, Johns Hopkins University.
Saverio Stranges, MD, PhD, University of Warwick.
Cynthia Mulrow, MD, Annals of Internal Medicine.
Lawrence J. Appel, Johns Hopkins University.
Edgar R. Miller III, MD, PhD, Johns Hopkins University.

 
REFERENCES

1. Bjelakovic G, Nikolova D, Gluud C. Antioxidant supplements to prevent mortality. JAMA. 2013;310(11):1178-9.
2. Gaziano JM, Sesso HD, Christen WG, Bubes V, Smith JP, MacFadyen J, et al. Multivitamins in the prevention of cancer in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2012;308(18):1871-80.
3. Hercberg S, Galan P, Preziosi P, Bertrais S, Mennen L, Malvy D, et al. The SU.VI.MAX Study: a randomized, placebo-controlled trial of the health effects of antioxidant vitamins and minerals. Arch Intern Med. 2004;164(21):2335-42.
4. Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for preventing age-related macular degeneration. Cochrane Database Syst Rev. 2012;6:CD000253.
5. Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2012;11:CD000254.

Sam Prust

No affiliation

February 23, 2015

Vitamin Supplement Quality Not Addressed?

The study doesn't indicate the quality of the vitamins and supplements. As we've seen recently, some vitamin companies put fillers like sand in their supplements. Quality matters. I'd like to see the study again using high-quality whole food supplements.