By James J. Gormley
Howard Sesso and his Harvard colleagues have just come out with their PHS II paper, “Vitamins E and C in the Prevention of Cardiovascular Disease in Men: The Physicians’ Health Study II Randomized Controlled Trial” (JAMA 300[18]:2123-2133, 2008)
There is even a video in which a couple of the researchers are interviewed (http://pubs.ama-assn.org/media/2008jer/1109.dtl#vnrscript ). Suffice it to say that it is likely that mainstream media shall have a field day with this paper, regardless of what it says … and what it does not say.
In reference to what PHS II does say — and these are statements that will likely go unacknowledged by most media in the next few weeks — Sesso and colleagues themselves state:
“Moreover, results in PHS II did not corroborate the significant 24% reduction in cardiovascular death or the significant 26% reduction in major cardiovascular events among women aged 65 years or older in the Women’s Health Study.
In addition, the putative increase in hemorrhagic stroke attributed to vitamin E in PHS II, was, according to Sesso and colleagues, “not observed in other primary [de Gaetanoa, 2001; Lee, 2005] and secondary [GISSI, 1999; Yusuf, 2000; Lonn, 2005; Cook, 2007] prevention trials testing individual vitamin E supplement use.”
It is doubtful that these observations will make it into most coverage, however.
What does the established body of research on vitamins C and E really show?
A wide body of scientific evidence has established that taking antioxidant supplements — including vitamins C and E, beta carotene, selenium and zinc — can help reduce the risk of chronic disease.
That being said, we know that antioxidant supplements (and supplements, in general) are not magic bullets, but they can be an important complement to a healthful diet.
A number of landmark epidemiological studies have, in fact, established that vitamin E supplementation reduces cardiovascular disease progression and reduces mortality.
In the Cambridge Heart Antioxidant Study (CHAOS) (Lancet, 1996), investigators wanted to see if supplementation with 400 or 800 I.U. of vitamin E for roughly 510 days would reduce risk for myocardial infarction (MI) and cardiovascular death in 1,035 patients with ischemic heart disease (967 more received a placebo). The findings were that high-dose vitamin E supplementation significantly reduced the risk of cardiovascular death and non-fatal MI.
In a study by Boaz et al. (Lancet, 2000), hemodialysis patients with cardiovascular disease (aged 40 to 75 years) received either 800 I.U./day of vitamin E or a placebo for approximately 519 days. The results? There was a significant decrease in cardiovascular disease (endpoints) and myocardial infarction.
In another study from 2000 (Salonen et al., J Int Med), a combined supplement of both vitamin E and slow-release vitamin C reduced the progression of atherosclerosis in men by 74 percent over a three-year period of supplementation.
In the Nurses’ Health Study (Stampfer, 1993) of 87,000 female nurses over eight years, among the 13 percent of women who regularly used vitamin E supplements (of at least 100 I.U. per day), there was a 31 percent reduction in relative risk for nonfatal myocardial infarction and death from cardiovascular disease compared with women who did not take vitamin E.
In a study by Rimm (1993), in which 39,000 male health professionals were studied for four years, 17 percent of the men took vitamin E supplements. Of those who took the highest doses (median of 419 I.U. per day) had a 40 percent reduction in the relative risk for nonfatal myocardial infarction or death from coronary hearth disease.
That’s what the science really shows.
While every study, even those with null results, can contribute to the body of knowledge regarding nutritional supplementation and prevention of chronic or acute disease, it is always unfortunate when studies produce anomalous findings that contradict the already well established evidence that antioxidant vitamins are critical for health promotion, disease prevention and treatment.
Friday, November 14, 2008
Friday, October 31, 2008
The 2008 elections and dietary supplements
By James J. Gormley
As we approach the November elections, we may well wonder if one party or another is a better champion of dietary supplements.
Some political observers have suggested that the Democratic party may boast a few more anti-supplement foes in Congress than does the Republican party. But do party labels matter when it comes to dietary supplements?
What the Experts in Washington Tell Us
Edward Long, Ph.D., vice president of congressional relations for Washington, D.C. lobbying firm, Capitol Associates, Inc., said that there is no one completely pro-supplement and pro-health freedom party, and that different ideologies run through both major parties.
“There are two strains of Democrats,” noted Long. “One is a populist strain, which goes back to the 1890s, the goo-goos, the good government people who believe that American citizens need to be protected by government in every possible way and to be told what to do. It’s from this camp that a few of dietary supplements’ greatest critics have emerged.”
“Then there’s the more liberal, anarchistic side of the Democratic Party that goes back to the 1960s and 1970s, which holds that mainstream medicine doesn’t really work. It’s out of this strain that we have found a few of dietary supplements’ greatest advocates.”
What about the Republicans? Long said that while there is a sizeable subset of the Republican Party that is opposed to regulation, and over-regulation, in general, “there’s another strain that believes that, in certain cases, we need more regulation, such as with DHEA [dehydroepiandrosterone],” a beneficial supplement especially important for seniors.
When asked about dietary supplements and the upcoming general elections, David Seckman, the CEO and executive director of the Washington, D.C.-based dietary supplement industry group, the Natural Products Association, offered some insights.
“When it comes to supplements and how members of Congress vote on legislation impacting the industry,” said Seckman, “one rule seems to always ring true: supplement issues are truly non-partisan.” Looking at the many past and current legislative champions for the industry, Seckman added that “we have almost the same number of ‘friends’ and ‘champions’ on either side of the aisle.”
As to the presidential election, Seckman concluded that while “conventional wisdom says that Republicans favor less regulation, we need to remember that DSHEA [the Dietary Supplement Health and Education Act of 1994] was passed with a Democratic administration” and that “the industry has enjoyed fairly broad bipartisan support.”
Stay Connected to Advocacy Groups
This November, don’t assume that either of the major parties will necessarily be zeroing in on protecting our access to dietary supplements and the industry’s ability to provide them. That’s our job.
As consumers we can stay on top of opportunities for (and threats to) dietary supplements by visiting Citizens for Health (http://www.citizens.org) and clicking “Join Us” and the American Association for Health Freedom (http://www.healthfreedom.net) and clicking “Free Alerts.”
Health-food retailers can stay linked in to the issues by visiting the Natural Products Association website (http://www.naturalproductsassoc.org) and signing up for Action Alerts.
Communicate with Your Legislators
All of us should try to regularly communicate (effectively and politely) with our own district’s Senators and U.S. Representatives to ensure that our access to dietary supplements is always protected and that DSHEA is never weakened.
As we approach the November elections, we may well wonder if one party or another is a better champion of dietary supplements.
Some political observers have suggested that the Democratic party may boast a few more anti-supplement foes in Congress than does the Republican party. But do party labels matter when it comes to dietary supplements?
What the Experts in Washington Tell Us
Edward Long, Ph.D., vice president of congressional relations for Washington, D.C. lobbying firm, Capitol Associates, Inc., said that there is no one completely pro-supplement and pro-health freedom party, and that different ideologies run through both major parties.
“There are two strains of Democrats,” noted Long. “One is a populist strain, which goes back to the 1890s, the goo-goos, the good government people who believe that American citizens need to be protected by government in every possible way and to be told what to do. It’s from this camp that a few of dietary supplements’ greatest critics have emerged.”
“Then there’s the more liberal, anarchistic side of the Democratic Party that goes back to the 1960s and 1970s, which holds that mainstream medicine doesn’t really work. It’s out of this strain that we have found a few of dietary supplements’ greatest advocates.”
What about the Republicans? Long said that while there is a sizeable subset of the Republican Party that is opposed to regulation, and over-regulation, in general, “there’s another strain that believes that, in certain cases, we need more regulation, such as with DHEA [dehydroepiandrosterone],” a beneficial supplement especially important for seniors.
When asked about dietary supplements and the upcoming general elections, David Seckman, the CEO and executive director of the Washington, D.C.-based dietary supplement industry group, the Natural Products Association, offered some insights.
“When it comes to supplements and how members of Congress vote on legislation impacting the industry,” said Seckman, “one rule seems to always ring true: supplement issues are truly non-partisan.” Looking at the many past and current legislative champions for the industry, Seckman added that “we have almost the same number of ‘friends’ and ‘champions’ on either side of the aisle.”
As to the presidential election, Seckman concluded that while “conventional wisdom says that Republicans favor less regulation, we need to remember that DSHEA [the Dietary Supplement Health and Education Act of 1994] was passed with a Democratic administration” and that “the industry has enjoyed fairly broad bipartisan support.”
Stay Connected to Advocacy Groups
This November, don’t assume that either of the major parties will necessarily be zeroing in on protecting our access to dietary supplements and the industry’s ability to provide them. That’s our job.
As consumers we can stay on top of opportunities for (and threats to) dietary supplements by visiting Citizens for Health (http://www.citizens.org) and clicking “Join Us” and the American Association for Health Freedom (http://www.healthfreedom.net) and clicking “Free Alerts.”
Health-food retailers can stay linked in to the issues by visiting the Natural Products Association website (http://www.naturalproductsassoc.org) and signing up for Action Alerts.
Communicate with Your Legislators
All of us should try to regularly communicate (effectively and politely) with our own district’s Senators and U.S. Representatives to ensure that our access to dietary supplements is always protected and that DSHEA is never weakened.
Tuesday, October 28, 2008
Codex—U.S. and global implications
By James J. Gormley
Codex Alimentarius is Latin for “food code” or “food law”. The Codex Alimentarius Commission (CAC) is one of the international bodies recognized by both international treaties and the World Trade Organization (WTO) for establishing global food standards.
According to the advocacy organization Public Citizen, recent international trade agreements have caused a radical change in the impact of Codex. The General Agreement on Tariffs and Trade (GATT) of 1994 and other treaties have altered the nature of Codex standards by “designating Codex as the international body” establishing internationally recognized food safety standards for use in trade.
After global trade negotiations in 1994, several international agreements were established, agreements that were intended to blur the lines of distinction among different national regulatory requirements regarding public health and food safety and to eliminate barriers to international trade.
According to the New Zealand Food Safety Authority, “Codex standards are considered scientifically justified and are accepted as international yardsticks,” wrote the New Zealand authority in 2001. WTO member standards that differ from Codex standards may be challenged as trade barriers if they only allow lower levels that serve to restrict trade.
Critics Voice Concerns
According to the Center for International Development at Harvard University: “These measures are criticized by some who claim the agreements are too invasive and deny them sovereignty of domestic regulation. Others assert that the agreements do not go far enough and domestic regulation is often a form of protectionism. Developing countries protest that the standards promoted in the agreements lack their input and are dominated by the interests of developed countries.”
“In the highly contentious debate over genetically modified foods,” wrote the Center, “some non-governmental organizations argue that these agreements” make it hard for countries to make their own decisions as to, for example, simply banning or allowing GMOs for sale in their country.
Others have criticized Codex’ use of the same standards that apply to toxic chemicals and environmental hazards with food and dietary supplements.
Some observers have said that Codex’ application of the precautionary principle—banning something because it might be harmful—is hypocritical: it is applied to dietary supplements, where it is not needed, but it is not applied to toxic additives, where it is needed.
Other issues at stake
Codex is looking at what forms and potencies of vitamins and minerals should be allowed for international trade, allowing individual nations to restrict other forms and potencies. Codex does not currently address other ingredients used in dietary supplements.
Calls for inclusion of DHA (docosahexaenoic acid) and ARA (arachidonic acid), and exclusion of partially hydrogenated fats and high fructose corn syrup, in infant formula standards have seemingly fallen on deaf ears, as have many other issues, say some, including concerns about GMOs.
Sustainability is another issue on the Codex horizon that may impact how some U.S. companies operate in terms of ingredient sourcing and also in terms of rising global demand for eco-friendly harvesting and production.
So how does Codex affect me?
Codex can affect you in a few ways:
1. Its guidelines regarding risk assessment have the potential to support low potencies for nutritional ingredients; that impacts what is available on store shelves if the U.S. products have had to be dumbed down based on low potencies allowed in Europe and supported by Codex. Large companies that export rely on economies of scale that will encourage them to formulate for the broader world market with restricted forms and potencies.
2. There is the real risk that the US government may copy some of these foreign and international trade standards as maximum levels for its own citizens, thus restricting our right to buy the full range of currently available dietary supplements.
3. Codex’ foot-dragging on GMOs and unhealthful ingredients (such as trans fats and high fructose corn syrup) will encourage functional food and beverage manufacturers to continue to use these controversial cheap, fattening and sweetening substances.
Gormley Take-Away: While Codex apologists are telling you we have nothing to worry about and “the sky is falling” alarmists are saying that we have everything to worry about, very real concerns and opportunities, such as those outlined above, could get lost in the shuffle. Solution? Stay tuned to what our industry associations are saying about Codex but also stay tuned to what credible consumer health advocacy organizations are saying (such as Citizens for Health). That way, you will have different perspectives that are not always 180 degrees apart and which, together, offer you a balanced view, whether pro, con or wait-and-see.
Codex Alimentarius is Latin for “food code” or “food law”. The Codex Alimentarius Commission (CAC) is one of the international bodies recognized by both international treaties and the World Trade Organization (WTO) for establishing global food standards.
After global trade negotiations in 1994, several international agreements were established, agreements that were intended to blur the lines of distinction among different national regulatory requirements regarding public health and food safety and to eliminate barriers to international trade.
According to the New Zealand Food Safety Authority, “Codex standards are considered scientifically justified and are accepted as international yardsticks,” wrote the New Zealand authority in 2001. WTO member standards that differ from Codex standards may be challenged as trade barriers if they only allow lower levels that serve to restrict trade.
Critics Voice Concerns
According to the Center for International Development at Harvard University: “These measures are criticized by some who claim the agreements are too invasive and deny them sovereignty of domestic regulation. Others assert that the agreements do not go far enough and domestic regulation is often a form of protectionism. Developing countries protest that the standards promoted in the agreements lack their input and are dominated by the interests of developed countries.”
“In the highly contentious debate over genetically modified foods,” wrote the Center, “some non-governmental organizations argue that these agreements” make it hard for countries to make their own decisions as to, for example, simply banning or allowing GMOs for sale in their country.
Others have criticized Codex’ use of the same standards that apply to toxic chemicals and environmental hazards with food and dietary supplements.
Some observers have said that Codex’ application of the precautionary principle—banning something because it might be harmful—is hypocritical: it is applied to dietary supplements, where it is not needed, but it is not applied to toxic additives, where it is needed.
Other issues at stake
Codex is looking at what forms and potencies of vitamins and minerals should be allowed for international trade, allowing individual nations to restrict other forms and potencies. Codex does not currently address other ingredients used in dietary supplements.
Calls for inclusion of DHA (docosahexaenoic acid) and ARA (arachidonic acid), and exclusion of partially hydrogenated fats and high fructose corn syrup, in infant formula standards have seemingly fallen on deaf ears, as have many other issues, say some, including concerns about GMOs.
Sustainability is another issue on the Codex horizon that may impact how some U.S. companies operate in terms of ingredient sourcing and also in terms of rising global demand for eco-friendly harvesting and production.
So how does Codex affect me?
Codex can affect you in a few ways:
1. Its guidelines regarding risk assessment have the potential to support low potencies for nutritional ingredients; that impacts what is available on store shelves if the U.S. products have had to be dumbed down based on low potencies allowed in Europe and supported by Codex. Large companies that export rely on economies of scale that will encourage them to formulate for the broader world market with restricted forms and potencies.
2. There is the real risk that the US government may copy some of these foreign and international trade standards as maximum levels for its own citizens, thus restricting our right to buy the full range of currently available dietary supplements.
3. Codex’ foot-dragging on GMOs and unhealthful ingredients (such as trans fats and high fructose corn syrup) will encourage functional food and beverage manufacturers to continue to use these controversial cheap, fattening and sweetening substances.
Gormley Take-Away: While Codex apologists are telling you we have nothing to worry about and “the sky is falling” alarmists are saying that we have everything to worry about, very real concerns and opportunities, such as those outlined above, could get lost in the shuffle. Solution? Stay tuned to what our industry associations are saying about Codex but also stay tuned to what credible consumer health advocacy organizations are saying (such as Citizens for Health). That way, you will have different perspectives that are not always 180 degrees apart and which, together, offer you a balanced view, whether pro, con or wait-and-see.
Monday, September 01, 2008
The Fear Mongers
By James J. Gormley
On March 4th, 1933, in his first inaugural address, Franklin Delano Roosevelt delivered the following inspiring words: “So, first of all, let me assert my firm belief that the only thing we have to fear is fear itself […]”
On March 4th, 1933, in his first inaugural address, Franklin Delano Roosevelt delivered the following inspiring words: “So, first of all, let me assert my firm belief that the only thing we have to fear is fear itself […]”
Now while FDR was, at the time, addressing a nation in the depths of the Great Depression that had recently been rocked by bank runs and was experiencing crushing unemployment and epidemic business debt, if uttered now these same words could just as well apply to the irrational, yet no less viral, fear of dietary supplements on the part of certain scientists, legislators and public health officials today.
Today, we are experiencing a new Great Depression of unhealth and chronic disease, marked by conditions which modern medicine, with its drugs and invasive procedures, is often ill-equipped to safely and effectively handle.
Instead of bank runs, we are witness to countless “pharmacy runs” and visits to mainstream physicians.
In point of fact, Americans reportedly spent $287 billion dollars on prescription drugs in 20071 and $16.1 billion on over-the-counter drugs.2
In August 2008, the U.S. Centers for Disease Control and Prevention (CDC) noted that, in 2006, Americans paid 1.1 billion visits to doctors and clinics.3
With epidemic levels of obesity, insulin resistance and type 2 diabetes, our most critical national debt is the good health to which our country’s citizens are entitled.
With this backdrop of America
Since chemotherapy is known to be either ineffective or marginally effective but laden with toxic side-effects, I had hoped that this study (based on two phone surveys with cancer survivors) would add another rock to the foundation of research supportive of dietary supplements in supporting immunity, fending off cancer and reducing the side effects of cancer drugs.
Instead, the researchers (from Penn State University, UT-MD Anderson Cancer Center, Duke University and a VA Medical Center) chose to highlight supplement use among elderly cancer survivors while, at the same, time raising the specter of largely theoretical supplement dangers while soft-soaping their well-supported benefits.
For example, the authors’ main support for the argument that supplements could be “risky” are several articles by supplement critic Golan Bjelakovic who, in 2007, co-authored an article with the cynical title, “Surviving Antioxidant Supplements.” 5
The rest of the study by Miller and colleagues does not seem to really offer a coherent message. The paper, for example, indicates that the survey participants who used the most supplements were better educated, ate more fruits and vegetables, ate more grains and, in general, had better nutrient profiles than did their less healthy co-participants. Problems of equal access to nutritional supplements notwithstanding, how is this a problem?
Other parts of the paper suggest that older Americans do not get enough of certain nutrients (e.g., magnesium, calcium and vitamin D) but elsewhere the researchers warn that people should be careful to not get too much. The study also cautions older Americans against getting too much zinc while later bemoaning the fact that many cancer survivors need more of this mineral.
In addition to the lack of a clear, practical value to this Journal of Cancer Survivorship paper (aside from adding to usage data re supplement use in older Americans who are cancer survivors) and the mixed, in some cases contradictory, messages that are communicated relating to supplementation, there is a rich body of established research—largely ignored here by Miller and colleagues—which strongly supports the use of dietary supplements to: reduce cancer risk6-11, treat cancer patients after diagnosis or surgery12-16, and improve health markers or reduce side effects in patients undergoing chemotherapy17-21.
Why then do fear-mongering papers continue to get published (time and again) and attract undue media attention while the majority of studies that are supportive of dietary supplements and cancer are rarely cited by researchers or noted by reporters?
I think there are, perhaps, several reasons. One is that skepticism and cynicism are often mistaken for intellectual probity—people seem smarter when knocking something.
Another potential reason is misplaced paternalistic protectiveness: researchers may feel that they are serving a public good by alerting doctors and the world to the putative, albeit ephemeral and largely baseless, “dangers” of dietary supplements.
The fact that universities and their medical centers regularly receive endowments from pharmaceutical corporations may also have an insidious effect that trickles down to researchers who are on the bench, working with patients or punching data into their biostatistical calculators.
Ultimately, however, what matters most is that, armed with science and evidence-based facts (the results behind what actually works, and what doesn’t), we continue to be open to the benefits of dietary supplements in virtually all areas of health and wellness and not immediately, or uncritically, buy into the anti-supplement brigade’s usual messages designed to sow unreasoning doubt and inspire baseless fear.
References
- Colihan K. Shop around if you pay for pills. WebMD Health News. Website: http://www.medicinenet.com/. Accessed August 31, 2008.
- Consumer Healthcare Products Association (CHPA). OTC Retail Sales—1964-2007 [chart]. Website: http://www.chpa-info.org/. Accessed August 31, 2008.
- CDC. Americans made over 1 billion hospital and doctor visits in 2006. August 6, 2008. [press release] Website: http://www.cdc.gov/. Accessed September 1, 2008.
- Miller P et al. Dietary supplement use among elderly, long-term cancer survivors. Journal of Cancer Survivorship. Published online July 11, 2008.
- Gormley J. Antioxidant supplements won’t hurt us, but misinformation might. Blog: The Gormley Files http://www.thegormleyfiles.blogspot.com/. Posted online May 4, 2008.
- Reid ME et al. The nutritional prevention of cancer: 400 mcg per day selenium treatment. Nutrition and Cancer. 60(2):155-163, 2008.
- Weingarten MA et al. Dietary calcium supplementation for preventing colorectal cancer and adenomatous polyps. Cochrane Database of Systematic Reviews. 23(1):CD003548, 2008.
- Lappe JM et al. Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial. American Journal of Clinical Nutrition. 85(6):1586-1591, 2007.
Kirsh VA et al.- Galan P et al. Antioxidant status and risk of cancer in the SU.VI.MAX study: is the effect of supplementation dependent on baseline values? British Journal of Nutrition. 94(1):125-132, 2005.
- Duffield-Lillico AJ et al. Selenium supplementation, baseline plasma selenium status and incidence of prostate cancer: an analysis of the complete treatment period of the Nutritional Prevention of Cancer Trial. BJU International. 91(7):608-612, 2003.
- Li Z et al. Feasibility of a low-fat/high-fiber diet intervention with soy supplementation in prostate cancer patients after prostatectomy. European Journal of Clinical Nutrition. 62(4):526-536, 2008.
- Gold EB et al. Dietary factors and vasomotor symptoms in breast cancer survivors: the WHEL Study. Menopause. 13(3):423-433.
- Ishikawa H et al. Aged garlic extract prevents a decline of NK cell number and activity in patients with advanced cancer. The Journal of Nutrition. 136(3 Suppl):816S-820S, 2006.
- Stratton MS et al. Selenium and inhibition of disease progression in men diagnosed with prostate carcinoma: study design and baseline characteristics of the ‘Watchful Waiting’ Study. Anticancer Drugs. 14(8):595-600, 2003.
- Jatoi A et al. A cross-sectional study of vitamin intake in postoperative non-small lung cancer patients. Journal of Surgical Oncology. 68(4):231-236, 1998.
- Block KI et al. Impact of antioxidant supplementation on chemotherapeutic toxicity: a systematic review of the evidence from randomized controlled trials. International Journal of Cancer. 123(6):1227-1239, 2008.
- Read JA et al. Nutrition intervention using an eicosapentaenoic acid (EPA)-containing supplement in patients with advanced colorectal cancer. Effects on nutritional and inflammatory status: a phase II trial. Supportive Care in Cancer. 15(3):301-307, 2007.
- Mantovani G et al. A phase II study with antioxidants, both in the diet and supplemented, pharmaconutritional support, progestagen, anti-cyclooxygenase-2 showing efficacy and safety in patients with cancer-related anorexiz/cachexia and oxidative stress. Cancer Epidemiology, Biomarkers & Prevention. 15(5):1030-1034, 2006.
- Gramignano G et al. Efficacy of L-carnitine administration on fatigue, nutritional status, oxidative stress, and related quality of life in 12 advanced cancer patients undergoing anticancer therapy. Nutrition. 22(2):136-145, 2006.
- Altundag K et al. Selenium supplementation may increase the efficacy of cetuximab in metastatic colorectal cancer patients. Medical Hypotheses. 64(6):1162-1165, 2005.
Sunday, May 04, 2008
Antioxidant Supplements Won’t Hurt Us, But Misinformation Might
By James J. Gormley
Lately we’ve heard quite a lot about how nutritional supplements, including antioxidant vitamins, are regarded by a few scientists as a great danger—or so we might gather from recent media coverage that has treated us to such fear-mongering headlines as “Potential for harm in dietary supplements”(1), “Vitamin pills may do more harm than good” (2) and “Why some popular pills might kill you” (3). The scientific review to which these sensationalistic stories refer was a meta-analysis in the Cochrane Database of Systematic Reviews (4).
A meta-analysis is supposed to be careful re-review of many studies whose results are pooled together. The Cochrane Database meta-analysis, authored by Goran Bjelakovic and others, is an updated version of a review that originally appeared in the Journal of the American Medical Association (5) that had been roundly criticized by scientists.
While 67 clinical trials were included in this new review, most people are not aware that 748 trials were excluded for a number of reasons, including 405 studies that failed to show anybody died (6).
One could persuasively argue that the authors of this review only included studies which could be molded to support the viewpoint that antioxidant vitamins are dangerous.
Dr. Bjelakovic has made no bones about his skeptical attitude towards dietary supplements. In 2007, he co-authored an article in the Journal of the National Cancer Institute entitled: “Surviving Antioxidant Supplements” (7) and has posted an article on a newspaper syndicate entitled “Do antioxidant supplements work?” (8).
While meta-analyses, when properly conducted, can be an insightful tool; when ill used they are subject to bias by those who hold pre-determined conclusions and are seeking a way to force studies into them.
A wide body of scientific evidence has established that taking antioxidant supplements — including vitamins C and E, beta carotene, selenium and zinc — can help reduce the risk of chronic disease. That being said, we know that antioxidant supplements (and supplements, in general) are not magic bullets, but they can be an important complement to a healthful diet.
If we twist science to create worldwide distrust in healthful dietary supplements, then we are truly harming consumers.
References
1. Brody J. Potential for harm in dietary supplements. New York Times April 8th, 2008.
2. Vitamin pills may do more harm than good. Scotsman UK. http://news.scotsman.com/health/vitamin-pills-may-do-more.3984844.jp
3. Why some popular pills might kill you. The Herald UK. http://www.theherald.co.uk/news/news/display.var.2199569.0.Why_some_popular_pills_might_kill_you.php
4. G. Bjelakovic, D. Nikolova, L.L. Gluud, R.G. Simonetti, C. Gluud. Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD007176.
5. G. Bjelakovic, D. Nikolova, L.L. Gluud, R.G. Simonetti, C. Gluud. Mortality in randomized trials of antioxidant supplements for primary and secondary prevention: systematic review and meta-analysis. JAMA 2007 Feb 28;297(8):842-57.
6. Daniells S. The dangers of selective science. Nutraingredients.com April 12, 2008 [online news portal] http://www.nutraingredients.com/news/ng.asp?id=84792-meta-analysis-antioxidants-randomised-clinical-trials
7. Bjelakovic G and Gluud C. Surviving antioxidant supplements [editorial]. JNCI Journal of the National Cancer Institute 99(10):742-743, 2007.
8. Bjelakovic G. Do antioxidant supplements work? Project Syndicate [online]. http://www.project-syndicate.org/print_commentary/bjelakovic1/English
Lately we’ve heard quite a lot about how nutritional supplements, including antioxidant vitamins, are regarded by a few scientists as a great danger—or so we might gather from recent media coverage that has treated us to such fear-mongering headlines as “Potential for harm in dietary supplements”(1), “Vitamin pills may do more harm than good” (2) and “Why some popular pills might kill you” (3). The scientific review to which these sensationalistic stories refer was a meta-analysis in the Cochrane Database of Systematic Reviews (4).
A meta-analysis is supposed to be careful re-review of many studies whose results are pooled together. The Cochrane Database meta-analysis, authored by Goran Bjelakovic and others, is an updated version of a review that originally appeared in the Journal of the American Medical Association (5) that had been roundly criticized by scientists.
While 67 clinical trials were included in this new review, most people are not aware that 748 trials were excluded for a number of reasons, including 405 studies that failed to show anybody died (6).
One could persuasively argue that the authors of this review only included studies which could be molded to support the viewpoint that antioxidant vitamins are dangerous.
Dr. Bjelakovic has made no bones about his skeptical attitude towards dietary supplements. In 2007, he co-authored an article in the Journal of the National Cancer Institute entitled: “Surviving Antioxidant Supplements” (7) and has posted an article on a newspaper syndicate entitled “Do antioxidant supplements work?” (8).
While meta-analyses, when properly conducted, can be an insightful tool; when ill used they are subject to bias by those who hold pre-determined conclusions and are seeking a way to force studies into them.
A wide body of scientific evidence has established that taking antioxidant supplements — including vitamins C and E, beta carotene, selenium and zinc — can help reduce the risk of chronic disease. That being said, we know that antioxidant supplements (and supplements, in general) are not magic bullets, but they can be an important complement to a healthful diet.
If we twist science to create worldwide distrust in healthful dietary supplements, then we are truly harming consumers.
References
1. Brody J. Potential for harm in dietary supplements. New York Times April 8th, 2008.
2. Vitamin pills may do more harm than good. Scotsman UK. http://news.scotsman.com/health/vitamin-pills-may-do-more.3984844.jp
3. Why some popular pills might kill you. The Herald UK. http://www.theherald.co.uk/news/news/display.var.2199569.0.Why_some_popular_pills_might_kill_you.php
4. G. Bjelakovic, D. Nikolova, L.L. Gluud, R.G. Simonetti, C. Gluud. Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD007176.
5. G. Bjelakovic, D. Nikolova, L.L. Gluud, R.G. Simonetti, C. Gluud. Mortality in randomized trials of antioxidant supplements for primary and secondary prevention: systematic review and meta-analysis. JAMA 2007 Feb 28;297(8):842-57.
6. Daniells S. The dangers of selective science. Nutraingredients.com April 12, 2008 [online news portal] http://www.nutraingredients.com/news/ng.asp?id=84792-meta-analysis-antioxidants-randomised-clinical-trials
7. Bjelakovic G and Gluud C. Surviving antioxidant supplements [editorial]. JNCI Journal of the National Cancer Institute 99(10):742-743, 2007.
8. Bjelakovic G. Do antioxidant supplements work? Project Syndicate [online]. http://www.project-syndicate.org/print_commentary/bjelakovic1/English
Sunday, April 06, 2008
So what's the big (low-fat) deal?
By James J. Gormley
Okay, so $415 million later the Women’s Health Initiative (WHI) Dietary Modification Trial not long back proved what we in the health-food camp have already known for ages — that fat balance and fat quality are key in promoting health and reducing the risk of cancer and heart disease.
The biggest-ever study to look at whether a low-fat diet can lower the risk of cancer or heart disease — one involving nearly 49,000 women aged 50 to 79 who were followed for eight years — found that, overall, a low-fat diet had no protective effect against these diseases.
As Harvard’s Dr. Walter Willett pointed out to the Washington Post at the time, “This should be the nail in the coffin for low-fat diets.”
Maybe, but low-fat and non-fat were, after all, bright, shining beacons of hope from a medical/public-health establishment that has, over the years, produced a series of health intifadas against such erstwhile “evils” as butter (not bad for us in moderation), salt (no persuasive evidence that it’s bad for the heart) and later, of course: fat.
Although public health groups are now saying that they had already well abandoned the “fat is bad” mantra a long time ago, the truth is that, as recently as 2000, the National Cancer Institute (NCI) was issuing cheerleading recommendations for low-fat and high-fiber diets in its Action Guide for Healthy Eating:
“Much research in the last few years has shown that […] eating a healthy diet, low in fat, high in fiber […] may help to lower cancer risk.” The NCI’s related “Action List for Fat” calls for consumers to use reduced-fat or non-fat salad dressings, low fat and fat-free foods and, you guessed it, margarine.
Today, it is known that low-fat salad dressings ironically lead to more weight gain than do their full-fat counterparts since tons of the fat-deprived dressings are heaped on salads since these poor cousins don’t make people feel full.
In terms of high-fiber, a 2005 review of 13 studies that appeared in the Journal of the American Medical Association found that high-fiber diets did not reduce the risk of colon cancer. We also know today that traditional tub margarine is loaded in heart-unfriendly partially hydrogenated (trans) fats.
One danger of these findings about the failings of low-fat diets is that people may feel the converse is true — that we can eat fat (of any kind) in unlimited quantities. False — saturated and trans fats will always be unhealthful, yes, however supplementation with high-potency, purified omega-3 fats is very healthful (and always will be).
Another danger is that people might believe that all dietary advice is unreliable and bad, and that everything should be discounted, which would be very wrong.
Although it is too bad the study did not employ generous levels of essential fats from the Mediterranean Diet, which is rich in omega-9 fat (olive oil) and omega-3 fats (mainly from fish) rather than cutting down all fat, alas it did not.
As I wrote, in DHA—A Good Fat, in 1999, “A balance of fats is what’s critical. […] a balance which existed, by and large, prior to the cholesterol crazes and low-fat/fat-free mania” that began a few decades ago.
Take away? Let’s keep eating healthfully, exercising, and thoughtfully supplementing, while feeling just a wee bit smug that we were right all along.
[Adapted from an editorial that originally appeared in Remedies magazine]
Okay, so $415 million later the Women’s Health Initiative (WHI) Dietary Modification Trial not long back proved what we in the health-food camp have already known for ages — that fat balance and fat quality are key in promoting health and reducing the risk of cancer and heart disease.
The biggest-ever study to look at whether a low-fat diet can lower the risk of cancer or heart disease — one involving nearly 49,000 women aged 50 to 79 who were followed for eight years — found that, overall, a low-fat diet had no protective effect against these diseases.
As Harvard’s Dr. Walter Willett pointed out to the Washington Post at the time, “This should be the nail in the coffin for low-fat diets.”
Maybe, but low-fat and non-fat were, after all, bright, shining beacons of hope from a medical/public-health establishment that has, over the years, produced a series of health intifadas against such erstwhile “evils” as butter (not bad for us in moderation), salt (no persuasive evidence that it’s bad for the heart) and later, of course: fat.
Although public health groups are now saying that they had already well abandoned the “fat is bad” mantra a long time ago, the truth is that, as recently as 2000, the National Cancer Institute (NCI) was issuing cheerleading recommendations for low-fat and high-fiber diets in its Action Guide for Healthy Eating:
“Much research in the last few years has shown that […] eating a healthy diet, low in fat, high in fiber […] may help to lower cancer risk.” The NCI’s related “Action List for Fat” calls for consumers to use reduced-fat or non-fat salad dressings, low fat and fat-free foods and, you guessed it, margarine.
Today, it is known that low-fat salad dressings ironically lead to more weight gain than do their full-fat counterparts since tons of the fat-deprived dressings are heaped on salads since these poor cousins don’t make people feel full.
In terms of high-fiber, a 2005 review of 13 studies that appeared in the Journal of the American Medical Association found that high-fiber diets did not reduce the risk of colon cancer. We also know today that traditional tub margarine is loaded in heart-unfriendly partially hydrogenated (trans) fats.
One danger of these findings about the failings of low-fat diets is that people may feel the converse is true — that we can eat fat (of any kind) in unlimited quantities. False — saturated and trans fats will always be unhealthful, yes, however supplementation with high-potency, purified omega-3 fats is very healthful (and always will be).
Another danger is that people might believe that all dietary advice is unreliable and bad, and that everything should be discounted, which would be very wrong.
Although it is too bad the study did not employ generous levels of essential fats from the Mediterranean Diet, which is rich in omega-9 fat (olive oil) and omega-3 fats (mainly from fish) rather than cutting down all fat, alas it did not.
As I wrote, in DHA—A Good Fat, in 1999, “A balance of fats is what’s critical. […] a balance which existed, by and large, prior to the cholesterol crazes and low-fat/fat-free mania” that began a few decades ago.
Take away? Let’s keep eating healthfully, exercising, and thoughtfully supplementing, while feeling just a wee bit smug that we were right all along.
[Adapted from an editorial that originally appeared in Remedies magazine]
Sunday, July 01, 2007
IADSA miasma
By James J. Gormley
Nine additives have been adopted by the Codex Alimentarius Commission (Codex) at levels proposed by the Brussels, Belgium-based International Alliance of Dietary/Food Supplements Associations (IADSA).
The following (mainly synthetic) additives have all been adopted as part of the official Codex General Standard for Food Additives (GSFA) at IADSA’s recommended levels of use in food supplement products: acesulfame potassium; aspartame; castor oil; cyclamates; neotame; polysorbates; polyvinyl alcohol; saccharin; and sucralose.
The result, which came at the recent Codex Alimentarius Commission in Rome, follows an active campaign by IADSA to push for the final adoption of these additives.
Last year, at meetings of both the Codex Additives Committee and the Codex Commission, IADSA managed to prevent the deletion of four additives including erythrosine, a cherry-pink/red synthetic coal tar dye banned for most uses in Norway and the US. IADSA also reportedly played a role in “successfully [raising] the levels of an additional three—BHA, BHT and carnauba wax.”
Most of the additives that IADSA has been campaigning for are far from natural and, in some cases, are either banned in certain countries (e.g., erythrosine) or are associated with negative and toxic effects.
For example, aesulfame K stimulates insulin secretion, possibly aggravating reactive hypoglycemia. In several rodent studies, it also produced lung and breast tumors, leukemia and chronic respiratory disease, even when less than the maximum doses were given. The Material Safety Data Sheet (MSDS) for aesulfame K indicates that it may be toxic to kidneys and the liver.
Cyclamates were banned as carcinogenic by the US Food & Drug Administration (FDA) and by Britain, Sweden, Denmark, Germany and Finland in 1969.
As far as neotame goes, like aspartame, some of the suggested concerns include gradual neurotoxic and immunotoxic damage from the combination of a formaldehyde metabolite (which is toxic at extremely low doses) and an excitotoxic amino acid.
According to the Environmental Defense Fund’s Chemical Scorecard, polyvinyl alcohol is suspected to be toxic to the gastrointestinal system and the liver and is a neurotoxin. Its main uses are as an adhesive or thickener in latex paints, hairsprays and glues; as a fiber reinforcement in concrete; and to help make Elmer’s glue.
Although the hazard warning regarding cancer was lifted for saccharin in 2001, questions about sucralose’s adverse effects are multiplying and there is a 2006 Citizen Petition calling for the FDA to revoke the approval of this compound due, in part, to reported adverse effects. Sucralose is a highly processed chemical sweetener manufactured with chlorine in a factory in McIntosh, AL, in a process that releases such toxins into the environment as cyclohexane.
Of course for every report questioning safety and asserting dangers, manufacturers of these synthetic chemicals will produce volumes of supportive data and folders bursting with positive scientific and regulatory opinions—so I am not going to waste your time, here, by attempting to issue a battery of specific challenges regarding these artificial compounds.
What I would ask is this, however:
1. Are US natural products companies truly in support of the use of artificial and synthetic chemical additives?
2. Are international organizations, such as IADSA, properly representing the will of the US dietary supplement industry, or of European “pharma-tritional” interests by pushing for these chemical additives?
If the answer is ‘no’ to either of these questions (or to both), then I would invite you to speak with your colleagues, vendors, suppliers and customers and to insist that organizations which claim to represent you do, in fact, just that.
If the answer is ‘yes’ to either or both of these questions, however, then I think we, as an industry, have much larger questions—and problems—to consider than these.
Are we truly the natural products industry—which embraces and encourages natural choices, natural ingredients and sustainable practices—or are we “the chemicals industry” that just so happens to have some natural products and ingredients.
I sure thought I was joining the former in early 1995 when I entered the health-food industry, as we called it then.
What about you?
[adapted from an editorial which originally appeared in the July 2007 issue of Nutrition Industry Executive magazine]
Nine additives have been adopted by the Codex Alimentarius Commission (Codex) at levels proposed by the Brussels, Belgium-based International Alliance of Dietary/Food Supplements Associations (IADSA).
The following (mainly synthetic) additives have all been adopted as part of the official Codex General Standard for Food Additives (GSFA) at IADSA’s recommended levels of use in food supplement products: acesulfame potassium; aspartame; castor oil; cyclamates; neotame; polysorbates; polyvinyl alcohol; saccharin; and sucralose.
The result, which came at the recent Codex Alimentarius Commission in Rome, follows an active campaign by IADSA to push for the final adoption of these additives.
Last year, at meetings of both the Codex Additives Committee and the Codex Commission, IADSA managed to prevent the deletion of four additives including erythrosine, a cherry-pink/red synthetic coal tar dye banned for most uses in Norway and the US. IADSA also reportedly played a role in “successfully [raising] the levels of an additional three—BHA, BHT and carnauba wax.”
Most of the additives that IADSA has been campaigning for are far from natural and, in some cases, are either banned in certain countries (e.g., erythrosine) or are associated with negative and toxic effects.
For example, aesulfame K stimulates insulin secretion, possibly aggravating reactive hypoglycemia. In several rodent studies, it also produced lung and breast tumors, leukemia and chronic respiratory disease, even when less than the maximum doses were given. The Material Safety Data Sheet (MSDS) for aesulfame K indicates that it may be toxic to kidneys and the liver.
Cyclamates were banned as carcinogenic by the US Food & Drug Administration (FDA) and by Britain, Sweden, Denmark, Germany and Finland in 1969.
As far as neotame goes, like aspartame, some of the suggested concerns include gradual neurotoxic and immunotoxic damage from the combination of a formaldehyde metabolite (which is toxic at extremely low doses) and an excitotoxic amino acid.
According to the Environmental Defense Fund’s Chemical Scorecard, polyvinyl alcohol is suspected to be toxic to the gastrointestinal system and the liver and is a neurotoxin. Its main uses are as an adhesive or thickener in latex paints, hairsprays and glues; as a fiber reinforcement in concrete; and to help make Elmer’s glue.
Although the hazard warning regarding cancer was lifted for saccharin in 2001, questions about sucralose’s adverse effects are multiplying and there is a 2006 Citizen Petition calling for the FDA to revoke the approval of this compound due, in part, to reported adverse effects. Sucralose is a highly processed chemical sweetener manufactured with chlorine in a factory in McIntosh, AL, in a process that releases such toxins into the environment as cyclohexane.
Of course for every report questioning safety and asserting dangers, manufacturers of these synthetic chemicals will produce volumes of supportive data and folders bursting with positive scientific and regulatory opinions—so I am not going to waste your time, here, by attempting to issue a battery of specific challenges regarding these artificial compounds.
What I would ask is this, however:
1. Are US natural products companies truly in support of the use of artificial and synthetic chemical additives?
2. Are international organizations, such as IADSA, properly representing the will of the US dietary supplement industry, or of European “pharma-tritional” interests by pushing for these chemical additives?
If the answer is ‘no’ to either of these questions (or to both), then I would invite you to speak with your colleagues, vendors, suppliers and customers and to insist that organizations which claim to represent you do, in fact, just that.
If the answer is ‘yes’ to either or both of these questions, however, then I think we, as an industry, have much larger questions—and problems—to consider than these.
Are we truly the natural products industry—which embraces and encourages natural choices, natural ingredients and sustainable practices—or are we “the chemicals industry” that just so happens to have some natural products and ingredients.
I sure thought I was joining the former in early 1995 when I entered the health-food industry, as we called it then.
What about you?
[adapted from an editorial which originally appeared in the July 2007 issue of Nutrition Industry Executive magazine]
Sunday, January 14, 2007
The Return of L-Tryptophan
By James J. Gormley
In the summer and fall of 1989, there was an epidemic outbreak of eosinophilia-myalgia syndrome (EMS) in the U.S. Symptoms of this heretofore rare disorder included: eosinophilia (high levels of this white blood cell); severe muscle pain; fever as high as 105 degrees F.; weakness; muscle and joint pain; swelling of the arms and legs; rash; shortness of breath; pneumonia; and potentially difficulty talking, memory impairment and trouble concentrating.
This outbreak was associated with L-tryptophan produced by a Japanese pharmaceutical company (Showa Denko K.K.); in fact, according to a 2001 position paper from the U.S. Food and Drug Administration (FDA), “more than 95 percent of the cases of EMS were traced to […] Showa Denko.”
In all, over 1,500 cases of EMS and 37 deaths were associated with this supply of L-tryptophan. Consequently, on November 17, 1989, the FDA and U.S. Centers for Disease Control and Prevention (CDC) issued a nationwide recall of all products containing 100 mg or more of L-tryptophan in a daily dose. That recall was expanded, on March 23, 1990, to all marketed product with certain exceptions, and, on February 19, 1991, was further enlarged to all legal products containing Showa Denko L-tryptophan.
And the Effects on the Category?
I spoke with Steven Bass, CEO of Tarzana-CA-based FTH Nutraceuticals, a maker of vitamins, antioxidants and amino acids, including pharmaceutical-grade Pure L-Tryptophan and Tryptophan Plus B6 and B2, and he had this to say: “The effects that the tryptophan debacle had on the nutritional industry—especially related to amino acids—were devastating. Millions of people who depended on L-tryptophan to boost their serotonin levels, and for other health reasons, were deprived of one of the most important natural supplements. Many had to resort to using side-effect-laden and dependency-creating doctor-prescribed sedatives, antidepressants and other drugs in order to replace the health effects of this nutrient.”
Enter Eli Lilly, the makers of Prozac, who were treated to a cover story in the March 26, 1990, edition of Newsweek magazine, “Prozac: A Breakthrough Drug for Depression,” which came out, coincidentally, only three days after the first expanded FDA recall of all marketed L-tryptophan supplements. Prozac quickly became the drug maker’s fastest rising star in 1989, contributing to windfall company profits of 22.5 percent on overall drug sales of $4.18 billion that year.
A DalÃ-esque Regulatory Limbo
Despite the fact that U.S.-manufactured L-tryptophan has actually been continually available for sale, statements and testimony by FDA injected confusion early on into the then already unclear regulatory status of this supplement.
In fact, on July 18, 1991, Douglas Archer, Ph.D., then deputy director of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), said, in testimony before the House of Representatives: “These approved uses [medical and infant formula applications], however, do not allow marketing of LT as a component of a dietary supplement.”
That’s interesting since, in a letter to me dated October 24, FDA spokesperson Arthur Whitmore, who’s with FDA’s office of food safety, defense and outreach wrote, quite clearly: “The agency has not concluded that any particular product is adulterated under the Act; therefore the FDA has taken no steps to limit the availability of dietary supplements containing L-tryptophan produced in the U.S.”
He added: “While we are unaware of conclusive scientific data that would establish that dietary supplement L-tryptophan would be safe, if a firm has information that it believes establishes that a product containing L-tryptophan is safe within the meaning of the Act, it could market such a product as a dietary supplement.”
“In light of the above,” concluded Whitmore, “Import Alert #54-04 was cancelled on April 29, 2005, which means that L-tryptophan intended for use in dietary supplements may be imported into the United States.”
Not only have retailers, manufacturers and suppliers been confused about L-tryptophan’s status, but so has Showa Denko K.K., which discontinued manufacturing and sale of L-tryptophan immediately after the 1989 outbreak. An October 20 note from Sara D. Schotland, of Washington, DC law firm, Cleary Gottlieb Steen & Hamilton LLP—which represents Showa Denko K.K.—noted: “we assume the ban on LT remains in effect.”
“You know, FDA never banned it as such, though several states did,” said Robert Ullman, partner at New York City-based Ullman, Shapiro and Ullman. “Even now, FDA won’t concede that the problem was solely that of a particular manufacturer’s product. At the time, the scope of the liability claims and what would have then been inescapable bad press associated with any attempt to market fully tested product were more than any company was willing to take on.”
A Favored Son of Holistic Practitioners
After the health crisis caused by the bad batch (or batches) from Japan, L-tryptophan stayed on as a continued favorite modality of practitioners and other health providers. It was a supplement that began to occupy a nebulous channel available to health practitioners via a network of progressive (and in many cases courageous) compounding pharmacists.
Julia Ross, M.A., founder of The Recovery Systems Clinic in Mill Valley, CA, and author of The Mood Cure (2002/2003), remembers it this way: “We began using L-tryptophan in 1994, when the compounding pharmacists defied the ban and began supplying it by prescription. We’ve seen over 3,000 clients since then, and a third of whom have used L-tryptophan with benefit.”
Daniel S. Smith, D.C., is the founder of the Alamo Chiropractic Healing Center in Alamo, CA, and president of Genesa Inc., a specialty manufacturer of the Total Amino Solution™ product which includes L-tryptophan and was, according to Smith, just picked up by Whole Foods Market in September.
A big believer in L-tryptophan, Smith said: “At the time L-tryptophan was taken off the market in 1989 I was not using nutritional support in my chiropractic office. The exciting thing, for me, was in 1999, when I discovered the effects of L-tryptophan in myself and my patients, this opened the door for me to really understand the importance of nutritional support as a primary recommendation in my chiropractic service.”
What About L-Tryptophan Today?
“The story of L-tryptophan,” said Marc Ullman, partner at New York City-based Ullman, Shapiro and Ullman, “is a story of the disappearance (and re-appearance) of a beneficial, well-liked ingredient from the marketplace due to a combination of regulatory concerns and marketplace overreaction.”
Marc Ullman added: “It’s a marketplace decision to undertake, or not undertake, the necessary effort to rehabilitate an ingredient, or product, in consumers’ minds.”
That being said, L-tryptophan products are once again being sold as dietary supplements in the U.S.; it seems that they have been rediscovered.
Source Naturals (Scotts Valley, CA) uses FTH Nutraceuticals’ raw ingredient L-tryptophan for its L-tryptophan dietary supplement. In addition, San Clemente, CA-based Doctor’s Best has recently come out with its Best Tryptophan with vitamin B6 & niacinamide. There are also a variety of online sources with product of, in some cases, unclear sourcing provenance, that are best for retailers to avoid.
What is L-tryptophan used for today? “L-tryptophan is commonly used for mood elevation; nervousness, premenstrual syndrome (PMS), jet lag, depression, chemical withdrawal and dieting (since it helps to reduce carbohydrate cravings),” added FTH’s Bass. “What most people don’t realize is that even during the time that it was not available (due to the one bad batch from Japan) it was still added to all baby formula manufactured in the U.S.”
“As consumers become educated about the importance of L-tryptophan and its vital role as it relates to the neurotransmitter, serotonin, I believe that they will want to use it daily as part of their wellness supplementation,” added Dr. Smith.
“The demand for L-tryptophan is increasing dramatically,” observed Bass, “which is one reason why we’re happy to be the largest distributor of L-tryptophan in the U.S.”
[Adapted from an article by James Gormley that was originally published in Vitamin Retailer magazine in December 2006]
In the summer and fall of 1989, there was an epidemic outbreak of eosinophilia-myalgia syndrome (EMS) in the U.S. Symptoms of this heretofore rare disorder included: eosinophilia (high levels of this white blood cell); severe muscle pain; fever as high as 105 degrees F.; weakness; muscle and joint pain; swelling of the arms and legs; rash; shortness of breath; pneumonia; and potentially difficulty talking, memory impairment and trouble concentrating.
This outbreak was associated with L-tryptophan produced by a Japanese pharmaceutical company (Showa Denko K.K.); in fact, according to a 2001 position paper from the U.S. Food and Drug Administration (FDA), “more than 95 percent of the cases of EMS were traced to […] Showa Denko.”
In all, over 1,500 cases of EMS and 37 deaths were associated with this supply of L-tryptophan. Consequently, on November 17, 1989, the FDA and U.S. Centers for Disease Control and Prevention (CDC) issued a nationwide recall of all products containing 100 mg or more of L-tryptophan in a daily dose. That recall was expanded, on March 23, 1990, to all marketed product with certain exceptions, and, on February 19, 1991, was further enlarged to all legal products containing Showa Denko L-tryptophan.
And the Effects on the Category?
I spoke with Steven Bass, CEO of Tarzana-CA-based FTH Nutraceuticals, a maker of vitamins, antioxidants and amino acids, including pharmaceutical-grade Pure L-Tryptophan and Tryptophan Plus B6 and B2, and he had this to say: “The effects that the tryptophan debacle had on the nutritional industry—especially related to amino acids—were devastating. Millions of people who depended on L-tryptophan to boost their serotonin levels, and for other health reasons, were deprived of one of the most important natural supplements. Many had to resort to using side-effect-laden and dependency-creating doctor-prescribed sedatives, antidepressants and other drugs in order to replace the health effects of this nutrient.”
Enter Eli Lilly, the makers of Prozac, who were treated to a cover story in the March 26, 1990, edition of Newsweek magazine, “Prozac: A Breakthrough Drug for Depression,” which came out, coincidentally, only three days after the first expanded FDA recall of all marketed L-tryptophan supplements. Prozac quickly became the drug maker’s fastest rising star in 1989, contributing to windfall company profits of 22.5 percent on overall drug sales of $4.18 billion that year.
A DalÃ-esque Regulatory Limbo
Despite the fact that U.S.-manufactured L-tryptophan has actually been continually available for sale, statements and testimony by FDA injected confusion early on into the then already unclear regulatory status of this supplement.
In fact, on July 18, 1991, Douglas Archer, Ph.D., then deputy director of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), said, in testimony before the House of Representatives: “These approved uses [medical and infant formula applications], however, do not allow marketing of LT as a component of a dietary supplement.”
That’s interesting since, in a letter to me dated October 24, FDA spokesperson Arthur Whitmore, who’s with FDA’s office of food safety, defense and outreach wrote, quite clearly: “The agency has not concluded that any particular product is adulterated under the Act; therefore the FDA has taken no steps to limit the availability of dietary supplements containing L-tryptophan produced in the U.S.”
He added: “While we are unaware of conclusive scientific data that would establish that dietary supplement L-tryptophan would be safe, if a firm has information that it believes establishes that a product containing L-tryptophan is safe within the meaning of the Act, it could market such a product as a dietary supplement.”
“In light of the above,” concluded Whitmore, “Import Alert #54-04 was cancelled on April 29, 2005, which means that L-tryptophan intended for use in dietary supplements may be imported into the United States.”
Not only have retailers, manufacturers and suppliers been confused about L-tryptophan’s status, but so has Showa Denko K.K., which discontinued manufacturing and sale of L-tryptophan immediately after the 1989 outbreak. An October 20 note from Sara D. Schotland, of Washington, DC law firm, Cleary Gottlieb Steen & Hamilton LLP—which represents Showa Denko K.K.—noted: “we assume the ban on LT remains in effect.”
“You know, FDA never banned it as such, though several states did,” said Robert Ullman, partner at New York City-based Ullman, Shapiro and Ullman. “Even now, FDA won’t concede that the problem was solely that of a particular manufacturer’s product. At the time, the scope of the liability claims and what would have then been inescapable bad press associated with any attempt to market fully tested product were more than any company was willing to take on.”
A Favored Son of Holistic Practitioners
After the health crisis caused by the bad batch (or batches) from Japan, L-tryptophan stayed on as a continued favorite modality of practitioners and other health providers. It was a supplement that began to occupy a nebulous channel available to health practitioners via a network of progressive (and in many cases courageous) compounding pharmacists.
Julia Ross, M.A., founder of The Recovery Systems Clinic in Mill Valley, CA, and author of The Mood Cure (2002/2003), remembers it this way: “We began using L-tryptophan in 1994, when the compounding pharmacists defied the ban and began supplying it by prescription. We’ve seen over 3,000 clients since then, and a third of whom have used L-tryptophan with benefit.”
Daniel S. Smith, D.C., is the founder of the Alamo Chiropractic Healing Center in Alamo, CA, and president of Genesa Inc., a specialty manufacturer of the Total Amino Solution™ product which includes L-tryptophan and was, according to Smith, just picked up by Whole Foods Market in September.
A big believer in L-tryptophan, Smith said: “At the time L-tryptophan was taken off the market in 1989 I was not using nutritional support in my chiropractic office. The exciting thing, for me, was in 1999, when I discovered the effects of L-tryptophan in myself and my patients, this opened the door for me to really understand the importance of nutritional support as a primary recommendation in my chiropractic service.”
What About L-Tryptophan Today?
“The story of L-tryptophan,” said Marc Ullman, partner at New York City-based Ullman, Shapiro and Ullman, “is a story of the disappearance (and re-appearance) of a beneficial, well-liked ingredient from the marketplace due to a combination of regulatory concerns and marketplace overreaction.”
Marc Ullman added: “It’s a marketplace decision to undertake, or not undertake, the necessary effort to rehabilitate an ingredient, or product, in consumers’ minds.”
That being said, L-tryptophan products are once again being sold as dietary supplements in the U.S.; it seems that they have been rediscovered.
Source Naturals (Scotts Valley, CA) uses FTH Nutraceuticals’ raw ingredient L-tryptophan for its L-tryptophan dietary supplement. In addition, San Clemente, CA-based Doctor’s Best has recently come out with its Best Tryptophan with vitamin B6 & niacinamide. There are also a variety of online sources with product of, in some cases, unclear sourcing provenance, that are best for retailers to avoid.
What is L-tryptophan used for today? “L-tryptophan is commonly used for mood elevation; nervousness, premenstrual syndrome (PMS), jet lag, depression, chemical withdrawal and dieting (since it helps to reduce carbohydrate cravings),” added FTH’s Bass. “What most people don’t realize is that even during the time that it was not available (due to the one bad batch from Japan) it was still added to all baby formula manufactured in the U.S.”
“As consumers become educated about the importance of L-tryptophan and its vital role as it relates to the neurotransmitter, serotonin, I believe that they will want to use it daily as part of their wellness supplementation,” added Dr. Smith.
“The demand for L-tryptophan is increasing dramatically,” observed Bass, “which is one reason why we’re happy to be the largest distributor of L-tryptophan in the U.S.”
[Adapted from an article by James Gormley that was originally published in Vitamin Retailer magazine in December 2006]
Saturday, July 08, 2006
NHRI-A New Future for Dietary Supplement Research ... and for American Health
By James J. Gormley
Over the last couple of years I've had the opportunity to become involved in The Natural Health Research Institute (NHRI), an independent "body that supports research into dietary supplements and other science-based approaches in order to:
*promote research into science-supported approaches to optimal health and wellness;
*bring respected scientists and world-renowned thought leaders together at scientific forums and conferences to share their dietary supplement and related science-based research with other scientists and the public;
*study and promote the public health benefits and cost-of-care savings that can be achieved by widespread, responsible use of science-validated dietary supplements and related modalities; and
*encourage young scientists to engage in university-directed research into both dietary supplements and the public-health/pharmacoeconomic benefits that can be achieved to help developed and developing countries reduce the prevalence of chronic disease and its associated cost-of-care burdens.
The group is working hard to make sure that consumers, scientists, the media, policymakers and legislators are fully informed about the science-validated power and promise of dietary supplements and related natural approaches to improve health and reduce disease around the world.
Over the last few years, the NHRI has held groundbreaking conferences on vitamin E, good fats and nutrients reducing disease risk, in addition to shining a light on controversial and important issues, including media misinformation, and being quoted as an expert source in Forbes.
I am very excited about the future of this organization to unite the best science with the most promising nutrients to produce a healthier tomorrow for the U.S. and the world.
Over the last couple of years I've had the opportunity to become involved in The Natural Health Research Institute (NHRI), an independent "body that supports research into dietary supplements and other science-based approaches in order to:
*promote research into science-supported approaches to optimal health and wellness;
*bring respected scientists and world-renowned thought leaders together at scientific forums and conferences to share their dietary supplement and related science-based research with other scientists and the public;
*study and promote the public health benefits and cost-of-care savings that can be achieved by widespread, responsible use of science-validated dietary supplements and related modalities; and
*encourage young scientists to engage in university-directed research into both dietary supplements and the public-health/pharmacoeconomic benefits that can be achieved to help developed and developing countries reduce the prevalence of chronic disease and its associated cost-of-care burdens.
The group is working hard to make sure that consumers, scientists, the media, policymakers and legislators are fully informed about the science-validated power and promise of dietary supplements and related natural approaches to improve health and reduce disease around the world.
Over the last few years, the NHRI has held groundbreaking conferences on vitamin E, good fats and nutrients reducing disease risk, in addition to shining a light on controversial and important issues, including media misinformation, and being quoted as an expert source in Forbes.
I am very excited about the future of this organization to unite the best science with the most promising nutrients to produce a healthier tomorrow for the U.S. and the world.
Friday, June 02, 2006
Welcome to The Gormley Files!
Welcome to my blog!
So where do we start?
Well, the guiding theme of The Gormley Files is
"My take (and your thoughts) on global health freedom, social and ecological justice, mainstream medicine and the politics of healing."
That is certainly a demanding course we've set in what are sometimes very turbulent seas.
From the historical underpinnings and guiding principles of the natural health movement through the Flexner Report, the Proxmire Vitamin Bill of the late 1970s, DSHEA (in 1994), Codex, the European Food Supplements Directive, global health and anti-hunger initiatives, environmental issues, GMOs, artificial sweeteners, and different perspectives of what is health and what is medicine.
I look forward to your checking back soon for my first "topic post" and, in the meantime, please check out www.jamesgormley.com.
We have an exciting road ahead of us!
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