I was not going to respond to the two recent news headlines about vitamins supplements. Both were negative, and not surprisingly, were given a great deal of attention by the news media. One was a story about vitamin E supposedly increasing the risk of prostate cancer, and the other was a story claiming that women taking vitamin supplements die sooner than women who do not take supplements.
Why was I not planning to comment? For one thing, neither story is really all that newsworthy. In both cases, the conclusions were surprising, in that they ran counter to what everyone expected and counter to the numerous studies that preceded them. They made no sense, could not be explained, and the nature of the study was such that much room was left for controversy as to whether the results were actually valid and meaningful. This leads to the first important observation I want to call to your attention:
The fact that a study is prominently featured on a news broadcast does not necessary mean it is a valid study. Instead, it just means that it is newsworthy. Unfortunately, newsworthy these days usually translates into “sensational,” “controversial,” or “sexy.” While these vitamin studies may not satisfy the “sexy” requirement, they certainly do satisfy the other two.
Another reason I was not going to comment is that few people really care. Most people who watched the news broadcast, or read about the studies in the newspaper, fall into one of three groups–those who are pro-vitamin supplement, those who are anti-vitamin supplement, and those who don’t really care either way.
There is no need to address comments to the first group, those who for various reasons are convinced of the value of nutritional supplementation, because they dismiss this kind of news as biased, illogical, politically motivated, etc. Their faith remains unshaken. Similarly, those at the other end of the spectrum are quick to embrace anything that seems to support their position that nutritional supplements are unnecessary, evil, a waste of money, etc.
No amount of positive data on vitamins will shake the skepticism of the anti-vitamin folks, and no amount of negative data on vitamins will undermine the optimism of the pro-vitamin folks. Certainly, nothing I say–no critique of the study’s methodology, no suggestions as to why the results were flawed–will change their minds. So, the second observation is as follows:
Few people really care. Those who understand the value of nutritional supplementation will be unimpressed with this type of news headline. Those who are anti-vitamin will gleefully accept the negative headlines, no matter how flawed the study and how illogical the results. And those who do not really care just, well, do not care.
Now, there are many flaws and there are many observations that can be made which diminish the significance of these studies. For those of you who really want to look at that, I will append a collection of such comments at the end of this story. For me, however, the bottom line is this. Studies like these should not be dismissed out of hand. But they have to be taken in context. If something does not make sense, seems illogical, cannot be explained, and runs counter to numerous previous studies, why would it be considered newsworthy?
Many of the “revelations” in these two studies actually support the information I have been giving for years. For example:
• Don’t take isolated nutrients. We always emphasize the importance of a balanced, comprehensive multivitamin-multimineral blend as the cornerstone, or foundation, of any nutritional or therapeutic regimen. I have never recommended an isolated dl-alpha tocopherol 400IU supplement.
• Don’t take high dose iron supplements unless under medical direction, especially if you are menopausal or male. I do not recommend total avoidance of iron, but typically suggest one-half the daily value (9 mg) for those who do not have need for a more therapeutic dose.
• Food is always the ideal way to get your vitamins and minerals. But lets not ignore the fact the few of us eat a sufficiently well-balanced diet to guarantee this. Research clearly shows that the average American is clearly deficient in one or more essential nutrients.
• Moderation is the key. Therapeutic use of vitamins, minerals and herbs is without question beneficial. But use common sense. Anything when taken to extremes can become dangerous.
A little common sense can go a long way when it comes to vitamin supplementation. Common sense, and guidance from qualified, educated health professionals. There is a lot of good information available, but there is also a lot of self-serving misinformation. If you think your supplement regimen may not be safe and optimal, I suggest you come by one of the Willner Chemists stores and talk to our pharmacists and nutritionists.
The overwhelming preponderance of evidence, scientific and anecdotal, supports the value of nutritional supplementation. These recent studies do not change that.
As promised, I will append a collection of comments and critiques to the two recent studies.
An increase in cancer was originally noted in the vitamin E-only group, but the results weren’t statistically significant.
The follow-up, however, which tracked the health of about half the trial’s original 35,000-plus participants, found a 17% increase in prostate cancer, compared with men who took a placebo. For every 1,000 men, 76 who took vitamin E supplements got prostate cancer, compared with 65 men who took placebo.
Dr. Minasian said the Select trial, which began in 2001, was prompted by animal studies, observational studies and secondary findings from other trials suggesting selenium and vitamin E protected against prostate cancer, which causes nearly 34,000 deaths in the U.S. a year.
It wasn’t clear why vitamin E might lead to an increase in prostate cancer, or why earlier studies suggested the opposite, Dr. Minasian said. More needs to be learned about how the nutrient acts at various steps on the progression from normal to cancerous tissue, she said.
New study on supplements’ effects on older women flawed, nutrition experts say
Caren Baginski, newhope360
Oct. 11, 2011
New study on supplements’ effects on older women flawed, nutrition experts say
Industry experts dissect supplement study’s flaws
The natural health industry rallies to respond to a controversial study published yesterday in the Archives of Internal Medicine that found that dietary supplements don’t contribute to lower death rates in older women. Natural health experts and the supplements industry weigh in on the flaws and biases they find in the research.
A new study published yesterday in the Archives of Internal Medicine titled “Dietary Supplements and Mortality Rate in Older Women” claims that dietary supplements overall are not helpful for increasing longevity in older women. The findings have natural health experts rallying to respond to what they say is a biased and scientifically skewed study on dietary supplements.
The study tracked the use of vitamin and mineral supplements in relation to total mortality in nearly 39,000 older women in Iowa from 1986 to 2008. Researchers found that dietary supplements, with the exception of calcium, do not reduce the death rate in older women. Calcium is by far the top-selling mineral supplement, accounting for 54 percent of the $2.2 billion in 2010 mineral supplements sales, according to Nutrition Business Journal.
The study’s conclusion went on to say that “in older women, several commonly used dietary vitamin and mineral supplements may be associated with increased total mortality risk [emphasis added].” The researchers associated use of multivitamins, vitamin B6, folic acid, iron, magnesium, zinc and copper with increased risk of total mortality when compared with groups that did not take supplements.
“It’s important to keep in mind that this is an associative—not a cause-and-effect—study,” said Duffy MacKay, vice president of scientific and regulatory affairs for Council for Responsible Nutrition (CRN), in a statement. “This study … attempts to tease out one piece of the healthy equation for good health—dietary supplements. CRN maintains that nutrients may be robbed of their beneficial effects when viewed as if they were pharmaceutical agents, with scientists looking to isolate those effects, good or bad.”
Industry experts dissect supplement study’s flaws
How does the industry, which regularly comes across studies such as, “Vitamin D reduces mortality rate by 20 percent,” respond to research that paints an entirely different picture of supplements’ benefits?
The same way it always does: consumer education—and pointing out precise biases and flaws in the “Dietary Supplements and Mortality Rate in Older Women” study.
“What the researchers and editors seemed to miss is that older women (or men) have a greater risk of death simply because of their age, their greater likelihood of having serious diseases, and their use of multiple drugs, a common cause of illness (from side effects),” said Jack Challem, The Nutrition Reporter.
Jacob Teitelbaum, MD, a holistic physician and coauthor of Real Cause, Real Cure (Rodale, 2011), said the researchers ignored a key point of the study: the fact that women who took supplements before the study were healthier than those who did not.
“One could come to the same conclusion about exercise not being helpful using this same statistical approach,” he said. Take for example a study with two control groups: those who exercise and those who do not, but both of which are put on a new exercise program. At the beginning of the study, those who already are exercisers are healthier than those who are not. By cancelling this fact out, and negating the prior health of the exercisers, you can find that exercise is not beneficial, he said.
That’s what the researchers did in this supplements study, Teitelbaum said. “The people taking multivitamins at the beginning of the study were statistically doing a lot better—there was less high blood pressure, less diabetes [than the non-supplement users]. The researchers totally ignored that.”
Teitelbaum adds that the omission of these facts wasn’t the only flaw in the study: “The hypothesis wasn’t to state whether supplements will harm or help. It was to see if they would harm, which gives you an idea of what their study was about.”
In a statement, Steve Mister, president and CEO of CRN, pointed to another flaw: The publication invited a scientist whose opinion is already controversial toward supplements to comment on the study.
“In the spirit of true scientific discourse, wouldn’t it have been more appropriate to invite commentary from a researcher who might have looked at the data in its entirety, with sufficient lead time, and provided a different perspective?” Mister asked. “It’s time scientific journals acknowledge they have some biases, just like industry.”
JAMA Article Is No Reason Not to Take Your Multivitamins
I want to share a statement from Natural Products Association (NPA) Vice President of Scientific and Regulatory Affairs Cara Welch, Ph.D., about recent concerns regarding the alleged risks of dietary supplements in the Archives of Internal Medicine:
“The Natural Products Association advocates that consumers use dietary supplements as part of a healthy lifestyle. Most vitamin and mineral supplements are taken to address or prevent deficiencies. While we would prefer that Americans get these nutrients from their diet, studies have consistently shown that they do not take in the essential compounds they need.
I’m always pleased to see analysis on the long-term effects of supplementation. This study, however, is quite limited in scope; the data is observational and self-reported so contributing factors are not addressed. Subsequently, the authors cannot conclude any cause and effect and there is no reason why women should change what they’re doing based on this report.
There are plenty of studies published that demonstrate the benefit of supplementation and fortification. This specific study should not dissuade the general public from the benefits of addressing a vitamin or mineral deficiency with dietary supplements. As always, consumers should discuss their supplement usage with their health care professional.”
The statement is being delivered to all trade publications and the mainstream press. Feel free to share it with your customers and colleagues.
John Gay, CAE
Executive Director and CEO
In response to these study findings, Steve Mister, president and CEO, the Council for Responsible Nutrition (CRN), commented: “Consumers continue to look for the best way to live long and healthy lives, and as much as we would like for science to easily give us answers, the fact is science is not black and white. But even more concerning is the recent drive to combine political agendas with what should be pure science. The supplement industry regularly gets accused of this practice—in some cases rightly so—yet medical journals seem to be given a pass, as if somehow they held no bias whatsoever.
“Within the article itself are a number of opinions, including: ‘Also, cumulative effects of widespread use, together with food fortification, have raised concern regarding exceeding upper recommended levels …’ It’s quite popular these days to talk about over nutrification, but in fact research consistently shows most people are falling short in several key nutrients.
“The authors advise that dietary supplements only be used ‘with strong medically based cause, such as symptomatic nutrient deficiency …’ Given the high dosages of iron reportedly being used by the women in the study, it is highly likely the participants were taking the high dosage of iron reported in the study under a physician’s care for an iron deficiency, which may itself have resulted in a shortened lifespan. But the piece purports to warn against over-the-counter (OTC) use of vitamins.
“The publication invited a commentary from a scientist whose opinion on supplements and their potential role in good health is already well-known, and whose own work has been the subject of controversy in scientific circles: ‘…Therefore, we believe politicians and regulatory authorities should wake up to their responsibility to allow only safe products on the market.’ In the spirit of true scientific discourse, wouldn’t it have been more appropriate to invite a commentary from a researcher who might have looked at the data in its entirety, with sufficient lead time, and provided a different perspective?
“Critics of dietary supplements will continue to advocate vitamins and minerals should be regulated like drugs, but even they should realize that although drugs undergo rigorous RCT testing, many safety issues for drugs still do exist. Furthermore if nutrients were regulated like drugs, the cost and availability of supplements would make it difficult for average consumers to make these products part of their healthy lifestyle.
“It’s time scientific journals acknowledge they have some biases, just like industry.”
Duffy MacKay, N.D., vice president, scientific and regulatory affairs, CRN, also commented, stating: “Dietary supplements are used by more than 150 million Americans in combination with other healthy lifestyle habits. This study, however, attempts to tease out one piece of the healthy equation for good health—dietary supplements. CRN maintains that nutrients may be robbed of their beneficial effects when viewed as if they were pharmaceutical agents, with scientists looking to isolate those effects, good or bad.
“It’s important to keep in mind that this is an associative—not a cause and effect—study. Further, the authors themselves have noted additional limitations. In fact, when the authors did their initial [minimum adjusted] analysis, it appears they actually found benefit for many of the supplements, not just calcium; yet instead of stopping there, they went on to ‘further adjust’ the data, possibly until they found statistics worthy of this publication’s acceptance. The study may make for interesting scientific water-cooler discussion, but certainly does not warrant sweeping, overstated concerns for elderly women.
“Further, the authors show their own bias with this statement: ‘We recommend that [dietary supplements] be used with strong medically based cause, such as symptomatic nutrient deficiency…’, which basically means these researchers would rather wait till we all get scurvy before acknowledging any need for supplemental nutrients.
“Our advice to consumers: your best chance for living a long and healthy life is to engage in healthy lifestyle practices, and many in the scientific community maintain that rational, reasonable use of vitamins and other supplements is part of that equation.”
Cara Welch, Ph.D., vice president, scientific & regulatory affairs, Natural Products Association (NPA), concurred with CRN’s comments, adding: “The majority of vitamin and mineral supplements are taken to address or prevent deficiencies. While we would prefer Americans get these nutrients from their diet, studies have consistently shown they do not take in the compounds essential for their health and supplementation can help. I’m always pleased to see research done on the long-term effects of supplementation; but this study is limited in that it is observational and self-reported so contributing factors are not addressed. There are plenty of studies published that demonstrate the benefit of supplementation and fortification, this specific study should not dissuade the general population from the benefit of addressing a vitamin/mineral deficiency with dietary supplements. And as always, consumers should discuss their supplement intake with their health care professional.
. . . about the study:
The use of dietary supplements in the United States has increased considerably over the last decade, according to background information in the article. Jaakko Mursu, Ph.D., of the University of Eastern Finland, Kuopio, Finland, and the University of Minnesota, Minneapolis, and colleagues used data collected during the Iowa Women’s Health Study to examine the association between vitamin and mineral supplements and mortality (death) rate among 38,772 older women (average age 61.6 years). Supplement use was self-reported in 1986, 1997 and 2004 via questionnaires.
Among the 38,772 women who started follow-up with the first survey in 1986, 15,594 deaths (40.2 percent) occurred over an average follow-up time of 19 years. Self-reported supplement use increased substantially between 1986 and 2004, with 62.7 percent of women reporting use of at least one supplement daily in 1986, 75.1 percent in 1997 and 85.1 percent in 2004.
Miriam Pappo, director of clinical nutrition at Montefiore Medical Center in the Bronx, N.Y., said the findings likely won’t drive doctors to stop recommending multivitamins to help patients get all the nutrients they need.
“No one disputes that oral intake of food to get your vitamins and minerals is the way to go,” said Ms. Pappo. However, “in reality, most of us don’t make it up to the nine [servings] a day of fruits and vegetables.”
Susan Fisher, chairwoman of the University of Rochester School of Medicine and Dentistry’s Department of Community and Preventive Medicine, noted that the study looks at deaths and not debilitating health conditions that vitamins can help prevent. “If your doctor suggests you should take supplements, it is still wise to follow that direction,” Dr. Fisher said.
Playing with Statistics
Two negative studies on supplements deserve brief comment. A report in the Journal of the American Medical Association found that men who had taken vitamin E supplements had a greater risk of developing prostate cancer, compared with men who did not take the vitamin. First, the vitamin E used in the study was synthetic, which is very different from the natural form. That alone could account for the finding. Second, the diagnoses of prostate cancer were made years after the men had stopped taking vitamin E supplements, which to me would suggest some other cause or combination of causes. Furthermore, prostate cancers are typically so slow growing that many of the cancers were probably undetectable when the study began, which would have further skewed the findings.
A second article in the Archives of Internal Medicine reported that older women who took a variety of supplements, including multivitamins, had a greater risk of death from disease. The only really significant association was between iron supplements and a greater risk of death, which has been known for years. What the researchers and editors seemed to miss is that older women (or men) have a greater risk of death simply because of their age, their greater likelihood of having serious diseases, and their use of multiple drugs, a common cause of illness (from side effects) and of death. For all we know, the risk of death might just as well have been associated with the use of the internet or cell phones.
These reports made for great headlines, but very poor science.
Multivitamins and mortality: ‘Seeing-what-you-want’ science
http://www.nutraingredients-usa.com/Research/Multivitamins-and-mortality-Seeing-what-you-want-science?utm_source=AddThis&utm_medium=More&utm_campaign=SocialMedia%23.Tph-yPPwoxE.printfriendlyOctober 14, 2011
During a week when the industry gathered under clear blue skies in Las Vegas to celebrate 15 years of SupplySide West, black clouds rolled in and unleashed a short sharp downpour: I am of course referring to the articles published on multivitamins and vitamin E.
First of all, research published in the Archives of Internal Medicine (a journal from the American Medical Association) concluded that older women who take multivitamins and copper supplements are at greater risk of dying from heart disease, cancer and other causes than women who don’t take them.
And then the headlines followed: Your Multi-Vitamin May Be Killing You (Shape Magazine) and Study: Vitamins may increase death risk in older women (USA Today).
We’ve seen similar studies before (more often than not published in journals from the American Medical Association) but what was different this time was the industry was ready, it had advanced warning and reacted immediately to their publications – this is progress.
Comments came in from the Natural Products Association (NPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA) to put the studies in context, to highlight their limitations (which just isn’t done in the main stream media), and for this I would commend the associations.
I would also suggest that the industry gather a team of academic champions to support their comments, much like it has champions in the Senate and elsewhere: A reaction from a trade association, no matter how measured and insightful, will always be seen by some as ‘damage control’ (as someone remarked on Twitter in relation to my coverage of the studies ).
Which leads me on to the studies themselves. The multivitamin study was observational, and relied on questionnaires – so it was always going to show correlation and not causation.
The researchers did tweak their results to account for a number of potential confounding factors, such as BMI, use of hormone replacement therapy, smoking status, alcohol intake, exercise levels, intakes of saturated fatty acids, and so on, but you can never fully remove the suspicion of confounding.
My one big question is over compliance – just because the women said they were supplement users, does not necessarily mean they were actually taking supplements. Compliance is notoriously low even in clinical trials where participants have signed up and agreed to swallow a capsule every day.
Just because these ladies ticked the box on a questionnaire that came in every 10 years does not mean that they were taking supplements – and the same supplements – everyday for all that time.
In addition, the researchers provide no information whatsoever about actual nutrient levels. No blood samples were taken and so we have no idea – none whatsoever – if the women had high levels of vitamin B6, for example, flowing through their veins. For all their posturing on the questionnaires, they may have been vitamin B6 deficient for all we know.
What did Twain say about statistics?
Also, if you look at the statistics, only copper and the multivitamins actually had a statistically significant association, and even then the one for multivitamins was relatively small.
The copper one was large, and you’d be hard pressed to find people to argue against excessive intakes of copper. Or iron, for that matter. There is too much of a good thing, as I shall come on to in a moment.
On the other hand, the apparent benefits for calcium supplements remained statistically significant, a result that may raise eyebrows for some in the medical fraternity following a high-profile meta-analysis in the British Medical Journal that concluded that calcium supplements may be dangerous.
Observational studies show correlation and not causation and headline writers running with Your Multi-Vitamin May Be Killing You (Shape Magazine) is irresponsible and naïve.
But the study should not be dismissed. It adds to the debate and perhaps does raise questions over when supplements should be used: And so on to the vitamin E-prostate SELECT study: A well-designed study, by all accounts, that shows the benefits of longer term analysis of study cohorts. However, an interesting comment by Bill Sardi, a well known personality in the industry, posted on NutraIngredients-USA today adds some nice context:
“The problem with these studies is that they don’t show cause-and-effect. The researchers could not surmise any mechanism for the increased deaths related to vitamin E use. The problem is that men with prostate cancer take more supplements and in higher doses. They may have also been wearing tennis shoes. But obviously these are only associated factors, not causal factors.”
So what to make of all this? It’s a high profile journal with a reputation of only publishing damning studies about supplements – look to the likes of the American Journal of Clinical Nutrition or the Journal of Nutrition and you will see tens, even hundreds of studies reporting benefits of good nutrition, of which supplements play a role. JAMA has a better PR department, it would seem, and the medical community looks to it with reverence – don’t get me wrong, it is a great journal… for medical research.
The comments from the supplement trade associations have a lot of wisdom about them. Their comments cannot be simply dismissed as spin or damage control (as someone on Twitter suggested), but they provide some balance to the JAMA articles. Supplements, as the name suggests, supplement the diet, and people with poor diets may benefit greatly.
A wider problem may be that the public view supplements as a fix-it for poor lifestyle. Perhaps industry and academia should work even harder on explaining that supplements should not be expected to undo a lifetime of poor habits or diet: Black clouds will always appear in the sky, but it doesn’t hurt to have an umbrella ready.
Be careful not to draw big conclusions from this study. Yes, the study was large—it included nearly 40,000 women. But it was an observational study. In other words, the study observed patterns. It did not randomly divide women into groups and assign them different combinations of vitamins to take. Randomized studies give us much cleaner science, without muddy conclusions.
For example, in this study it is possible that many of the women who were taking vitamins were more often feeling unwell in some way, or were seeing doctors more frequently, compared with the women who did not take vitamins. Women may have been taking vitamins in an effort to improve symptoms. If this is the case, who is to say that the vitamins were responsible for the difference of death rates? Other factors may have been to blame.
. . . News Review from Harvard Medical School – Do Vitamin Supplements Help or Harm?
By Mary E. Pickett, M.D.
Harvard Medical School