Purposeful Confusion?

UPDATE: 31 May 2010 (original post 6/19/09) -

The US Food and Drug Administration (FDA) lost its bid to overturn a health claim for selenium-containing dietary supplements last Thursday in the United States District Court for the District of Columbia. District Court Judge Ellen Huvelle ruled unconstitutional the FDA’s censorship of selenium dietary supplement claims relating to the reduction of cancer risk. Jonathan Emord of Emord & Associates on behalf of the plaintiffs in the case (including lead plaintiff ANH-USA; Durk Pearson and Sandy Shaw; and the Coalition to End FDA and FTC Censorship. The verdict, unless reversed on appeal, protects the First Amendment right of dietary supplement manufacturers to provide “qualified health claims”, which accurately communicate the state of science concerning dietary supplements. This is a remarkable seventh victory over the FDA by the Emord firm (six of which invalidated FDA health claim censorship).
The lawsuit was initiated last summer in response to the FDA’s 19th June 2009 decision to suppress selenium/cancer-risk reduction claims. Ten of the claims (all appealed by the plaintiffs) were held unconstitutionally censored. The plaintiffs expressed their belief that this violated their right to communicate truthful health information to the public. The judge found that the FDA had denied claims despite credible evidence supporting them and had thereby infringed on free speech.
Prior to this ruling the FDA required near conclusive scientific evidence for any nutrient claim. The judge ruled that so long as the claim is an accurate reflection of the state of science, the First Amendment protects it.

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UPDATE: 8 July - Please read what one of the good health organizations has to say about US censorship of scientifically-backed health claims for selenium.
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UPDATE: 21 June - Government Intervening in Vitamin Industry
Other reports on Centrum can be found here at Natural Health News using SEARCH.

By Lorraine Heller
“Multivitamins and minerals were the subject of one quarter of Adverse Event Reports (AERs) filed with FDA in the first six months of last year, but this does not mean that this product category is problematic, says the American Herbal Products Association (AHPA).

The trade group analyzed 598 AERs received by the US Food and Drug Administration (FDA) between January 1 and June 30 2008, which highlighted potential adverse health effects of dietary supplement products.

However, although 25 per cent of these were for mainstream multivitamins and minerals, the findings must not be misinterpreted as identifying this as the most dangerous class of products, said Michael McGuffin, director AHPA.

‘This is not a cause and effect reporting system, it’s an association system. So although a large part of the AERs are linked to multivitamins, this does not mean that they are dangerous. It simply reflects usage patterns, and the most used dietary supplements are multivitamins,’ McGuffin told NutraIngredients-USA.com.

The AER reports were obtained by AHPA via Freedom of Information (FOI) requests with FDA. AHPA revealed its analysis of these reports at the recent SupplySide East trade show in Secaucus, New Jersey.

A number of supplement brands or products were repeatedly flagged up in the AERs. The most common single product reports were for:

• Total Body Formula (93 reports)
• Bayer One a Day (all formulas) (81 reports)
• Centrum (all formulas) (25 reports)
• Flintstones Vitamins (all formulas) (24 reports)
• Mainstream calcium products (25 reports)

However, McGuffin again cautioned that this does not implicate these brands or products as being dangerous. It reflects the frequency of reporting by a select number of companies, which have put systematic reporting systems in place, he explained.

Out of the 600 AERs reviewed by AHPA, 44 percent were for combination products, 25 percent were for vitamins and minerals, 10 percent were for ‘other primary ingredients’ products, and 5 percent were for herbals.

The majority (almost 60 percent) of reports had been submitted by companies, while just under a third (30 percent) were submitted by consumers. Around 10 percent were sent in by health professionals.

The majority of cases (73 percent) were female consumers, and 54 percent of reports were for people aged between 50 and 79. Again, this reflects supplement usage, said McGuffin.”

Back in the 1980s there were daily publications of articles promoting the health benefit of selenium to protect men's prostate health. I've posted an ACS article from 2002 that shows this information below.

Several weeks ago I posted a discussion about a study that attacked selenium, showing mostly the ignorance of the people involved or interviewed regarding the effective form of selenium.

Generally inexpensive sodium selenite is the form used in synthetic products and it isn't always properly absorbed.

Now today Bayer is taking flack over its synthetic product, One-A-Day for Men. Well they should but not because of the concerns about synthetic vitamins, but for the fact that selenium - in the right form - is helpful for men's health and that of the prostate too.

Isn't it confusing? And do you really think medicine is progressing in providing prevention?

Group: Bayer ads mislead about prostate
Published: June 19, 2009 at 12:17 AM

A U.S. advocacy group notified Bayer Healthcare it will sue if the company continues to claim the selenium in its vitamins may reduce prostate cancer risk.

David Schardt, senior nutritionist at The Center for Science in the Public Interest in Washington, said advertisements and labels for One A Day Men's 50-plus Advantage and One A Day Men's Health Formula multivitamins claim "emerging research" suggests selenium may reduce the risk of prostate cancer.

However, leading prostate cancer researchers say there is scant evidence to support such a claim and have joined CSPI in urging the Federal Trade Commission to put an immediate stop to the claims, Schardt says.

"Bayer is exploiting men's fear of prostate cancer just to sell more pills," Schardt says in a statement. "The largest prostate cancer prevention trial has found that selenium is no more effective than a placebo. Bayer is ripping people off when it suggests otherwise in these dishonest ads."

A seven-year study found last year that selenium does not prevent prostate cancer in healthy men, Schardt says.

"We are aware of CSPI's complaint and are in the process of reviewing their allegations, in the meantime, we stand behind all claims made in support of our products, including One A Day multivitamins," Bayer officials said in a statement to WebMD. "The claims made in support of selenium are based on an FDA-approved qualified health claim."

© 2009 United Press International, Inc. All Rights Reserved.

Study Links Selenium and Age to Prostate Cancer Risk
Mineral May Reduce Risk
Article date: 2002/01/02 from the American cancer Society

A new study suggests that the mineral selenium may be important in reducing prostate cancer risk as men age, according to a report in the Journal of Urology (Vol. 166, No. 6: 2034-2038).

The research suggests that the older men get, the less selenium they are likely to have in their blood. This may explain why a man's chance of getting prostate cancer goes up as he ages, since there may be a relationship between very low selenium levels and increased risk of prostate cancer.

“Our results suggest the possibility that selenium supplements may be especially beneficial for older men,” said lead author, James D. Brooks, MD, assistant professor of urology at Stanford University Medical Center in Palo Alto, Calif.

Brooks cautioned that too much selenium can be toxic. The Institute of Medicine, a government organization that determines the recommended dietary allowances (RDA) of vitamins and minerals, suggests a daily selenium intake of 55 micrograms (mcg) daily for men over the age of 14. Selenium is found in organ meats (liver), seafood and vegetables (which depend on the selenium content of the soil). The maximum intake daily of selenium should not exceed 400 mcg daily from all sources.

Lowest Selenium Levels Raised Prostate Cancer Risk
Most Americans get enough selenium, Brooks noted, but in some areas of the US there is not much selenium in the soil, so there may not be enough in drinking water or in food.

To study the relationship between selenium and prostate cancer, Brooks and colleagues compared the levels of selenium in the blood from 52 men taken before they developed prostate cancer, to the selenium levels in blood given by 96 men who did not later develop prostate cancer.

These men were all part of an ongoing study called the Baltimore Longitudinal Study of Aging. They were examined about every two years over a long period of time.

Men with the least amount of blood selenium were four to five times more likely to develop prostate cancer in the next few years than those with more, the researchers found.

“There may be a threshold level — a certain amount needed to lower risk — but beyond that, adding more selenium may not offer any more protection,” said Brooks.

Study First to Link Selenium Levels, Risk and Age
An American Cancer Society (ACS) expert on cancer and nutrition said the Stanford study confirms earlier studies that show selenium may reduce risk of prostate cancer by as much as 60%, and it adds new information as well.

“This is the first study to show that selenium levels may drop as age increases, which could help explain why men’s chances of developing prostate cancer go up as they get older,” said Carmen Rodriguez, MD, a senior epidemiologist in the ACS department of Epidemiology and Surveillance Research.

But Rodriguez cautioned that the study had so few men in it that it’s difficult to be sure that conclusions from it are meaningful.

And she expressed concern that blood samples weren’t necessarily collected at the same ages from men who developed prostate cancer later and from those who didn’t, making the comparison not as equal as a better matched one.

Study Raises Questions Likely to be Addressed by SELECT Trial
Rodriguez said men interested in those questions and in learning more about reducing their risk of prostate cancer with selenium and/or vitamin E may want to participate in the SELECT Trial trial, or wait for its outcome, she noted.

“In the meantime, all men can use the knowledge we already have to keep their prostate cancer risk as low as possible by learning the risk factors for prostate cancer, and how to actively reduce their chances of developing the disease,” noted Rodriguez.

Men's Health

Help Prevent Colon Cancer: Hope for Whole Health

Natural Health News has at least 20 posts related to vitamins and other help that is protective for colon cancer.

Now another article relives us from the negative hype about vitamin supplements and cancer that you have heard now for at least a decade.

Selenium, Omega-3s May Stave Off Colorectal Cancer

HealthDay Reporter by Jennifer Thomas
TUESDAY, Dec. 8 (HealthDay News) -- Certain dietary supplements appear to affect the development of colorectal cancer or its recurrence, two new studies suggest.

In one study, researchers from the U.S. National Institute for Environmental Health Sciences found that eating a diet high in omega-3 fatty acids cut the risk of developing colorectal cancer by nearly 40 percent. In the other study, from cancer researchers in Italy, consumption of a dietary supplement containing selenium was found to reduce the chances of having polyps recur by a similar amount.

Both studies were to be presented Dec. 7 in Houston at a conference on cancer prevention sponsored by the American Association for Cancer Research.

In the selenium study, 411 people, 25 to 75 years old, who'd had one or more colorectal polyps removed took either a supplement or a placebo. The supplement, described as an antioxidant compound, contained 200 micrograms of selenomethionnine (a combination of selenium and methionnine - Our Note: This is the best form of selenium according to the most currant science), 30 milligrams of zinc, 6,000 international units of vitamin A, 180 milligrams of vitamin C and 30 milligrams of vitamin E.

Participants had a colonoscopy one year, three years and five years after starting the regimen.

Polyps recurred in 4.2 percent of those taking the supplement, compared with 7.2 percent of the placebo group. Overall, the study found, people taking the supplement had about a 40 percent reduction in risk for a return of polyps.

The researchers estimated that, after 15 years, about 48 percent of those taking the supplement would still be free of polyps, versus about 30 percent of those not taking the supplement.

Polyps, or adenoma, are benign growths on the large bowel. Though only a small proportion progress to become cancer, about 70 to 80 percent of colorectal cancer cases begin as polyps, according to the American Association for Cancer Research. About one in four people, most older than 60, will have at least one adenoma.

Selenium is found in soil (Our Note: Western US states bordering Canada are known to be severely low in selenium and as such has a negative impact on thyroid function.), and human consumption comes by eating plants that have absorbed the nutrient or fish or animals that have eaten plants as part of their diet. "The content of selenium in the food depends on the soil content of this trace element, and in the same country there are areas at high, adequate or low content of selenium in the soil," said the study's lead author, Dr. Luigina Bonelli, head of the unit of secondary prevention and screening at the National Institute for Cancer Research in Genoa, Italy.

Earlier research had suggested that selenium can inhibit cell proliferation in the colon and rectum, Bonelli said.

Michele Forman, a professor of epidemiology at the M.D. Anderson Cancer Center in Houston, said that, though the findings are interesting, it's impossible to tell if the benefit was attributable to the selenium or to the other vitamins and minerals included in the supplement.

"You really don't know if it's the selenium or some combination that reduces risk of recurrence," Forman said.

In addition, the daily dosages of vitamins A and E taken by the participants were higher than the recommended daily allowances, Forman added. High levels of such vitamins can be detrimental, she said. (Our note: Not all supplements at high dose levels are harmful.)

In the omega-3 study, U.S. researchers surveyed 1,509 whites and 369 blacks about their dietary habits in the past year. About half of the participants had colorectal cancer.

Among the white participants, those whose diets were in the highest fourth of omega-3 fatty acid consumption were 39 percent less likely to have colorectal cancer than those in the lowest fourth. However, for reasons the authors said they did not know, no association was noted between omega-3s and a reduction of colorectal cancer risk among black participants. The disease occurs at a higher rate among blacks than whites.

"Our finding clearly supports the evidence from previous experimental and clinical studies showing that long-chain omega-3 fatty acids inhibit tumor growth," said the study's lead author, Sangmi Kim, a postdoctoral fellow at the U.S. National Institute of Environmental Health Sciences in Research Triangle Park, N.C.

Kim said the research supports boosting omega-3 intake through diet or perhaps by taking an omega-3 supplement. Omega-3 fatty acids are found in fish, especially oily fish such as salmon, mackerel, herring, anchovies, sardines and tuna. Plant-based sources include flax and flaxseed oil, Brussels sprouts, soybeans and (soybean oil, canola oil - NOTE: We suggest you avoide both these oils), spinach, walnuts and kiwi.

Previous studies have suggested that omega-3 fatty acids act as anti-inflammatory agents and help prevent cancer. But in the new study, Forman noted, participants were asked about their diets after they had been diagnosed with colorectal cancer so it's possible that their recollections were not fully accurate.

In addition, she said, it's possible that the benefit was not the result of omega-3s. Those who ate more fish might have had a healthier diet overall, she said.

"Were they eating a salmon-and-broccoli diet or a hamburger-and-french-fry diet?" Forman asked. "We don't know enough to say that it's truly the effect of the omega-3s."

Our Note:  We beleive that the dose levels in the supplement mentioned in this areticle is well below therapeutic levels.

While I am not an institutionalized thinker, I am in support of those who have tried to help make more people aware of the role of nursing, probably a truly wholistic profession on its own. I would like to see the same support from the organizationally based groups to the work we do.

I will say however that I support this comment from the AHNA:

The American Holistic Nurses Association (AHNA) has formally requested that US Senator Tom Harkin (D-IA) not move to re-name the NIH National Center for Complementary and Alternative Medicine (NCCAM) the "National Center for Integrative Medicine." Harkin brought up the idea of the name change in public comments surrounding the Institute of Medicine Summit in February of this year. In a letter co-signed by 23 other nursing organizations, the AHNA wrote:
"There are so many in this country who enthusiastically support a vision to put integrative health care at the heart of national health reform. However, to facilitate this vision; to reinforce a more inclusive, representative, and collaborative partnering of every health and health-related profession and constituency; and to recognize and maximize the valuable contributions of all, we would like to suggest the renaming of the National Center for Complementary and Alterative Medicine to the National Center for Integrative Health and Healthcare. In transforming the health care paradigm, a shift in language can be a critical influence in supporting and adopting that change. The use of Integrative Health and Healthcare focuses on people’s health and well-being, rather than on a specific profession, and broadens the array of disciplines involved in promoting it."

As of this writing, Harkin had not formally responded to the nurses nor had an Integrator query to Harkin's staff elicited a response.

I do not support the use of the terms "integrative" or "complementary" in regard to health care.  I believe this promotes more separation from what used to be quite common, the "team" approach. And I believe it further sets up barriers to health and limits access both for providers but for patients.

In the classes I taught in the Pueget Sound area for so many years, always, in my discussion of vitamin E, its protective benefit for colon cancer was always noted.
See "Vitamins Enhance Chemotherapy" from leaflady.org

The Anti-Vitamin Train Keeps Rolling Along

UPDATE: Feb 09 -
AP writer LINDSEY TANNER has the inevitable position of meeting with my disdain over here story "Huge study boosts disappointment on multivitamins".
Her writing in my estimation is about the same low caliber as Carla Johnson another AP health writer who had worked at Spokane's Spokesman-Review.
Of course I don't look at these stories from the job oriented perspective of Johnson and Tanner; I look at them in a critical manner relevant to the factors that are known about the need for and effectiveness of using vitamin supplements.
It is unfortunate that AP fosters mainstream propaganda, rather than actually engaging in discovering whether or not the studies were good examples of junk science.
In this situation the studies were poorly designed, the schedule and dose of vitamins was not close to making a dent in the side of a Studebaker or Packard.

It will be a far sight better when we can get back to media stories with less or no bias, and until then we have ProPublica.org to help us keep on track, along with our own investigative efforts to substantiate fact.

You'll find many other posts here at Natural Health News discussing the benefits of vitamins for health and bogus studies via the search window.
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Personally I would like to see one of the investigators that do studies to show that vitamins are not helpful for health be required to do in-depth research on the vitamins prior to being funded. Maybe when the money train slows down they will approach their "research" from a different state of mind.

Double blind studies are a joke, and most serious researchers know this, but few will really say this is fact. All studies are affected by what is called the Rosenthal factor which has proven that all studies are altered in outcome by the mind-set of the lead investigator. A sharp skewer of data if I ever heard of one.

Vitamin E is an extremely effective anti-inflammatory vitamin and it helps oxygen (cancer doesn't like oxygen)cross the alveolar membrane in the lungs. Vitamin E also helps protect you from hair loss when undergoing standard medical cancer dictates. It also happens to have the effect of protecting you from colon cancer. And there are many more benefits, but it depends on the daily dose and the proper type of vitamin E supplement. (Not the synthetic or cheap stuff, but this seems to be what is relied on in most studies of late.)

Again, vitamin C reigns as one of the most beneficial vitamins for cancer prevention and treatment if you read the science that is found in nutrition journals or other journals that are "less aligned with maintaining the status quo".

Yet, while we see more and more anti-vitamin reports like this one -

Taking vitamin C or E does not reduce the risk of prostate cancers - or other forms of the disease, two large US studies suggest.

We also see some that seem to have a better insight on vitamin efficacy.

Vitamin E Shows Possible Promise In Easing Chronic Inflammation

ScienceDaily (2008-12-08) -- With up to half of a person's body mass consisting of skeletal muscle, chronic inflammation of those muscles -- which include those found in the limbs -- can result in significant physical impairment. Researchers have found that vitamin E shows promise in easing inflammation. ... > read full article

Just maybe the improved anti-inflammatory response is from the oxygen. And don't we already know that oxygen being a free radical scavenger, might just scavenge those cancer cells out from where they don't belong?

And as for selenium, this has been an effective anti-prostate cancer supplement, used in the correct form (selenomethionine) and in the correct dose for decades.

Without selenium, especially if you live in an area that is known geologically to have low selenium soil like the states bordering Canada, your thyroid won't function properly and low thyroid is clearly involved in immune issues, and may be a factor in cancer or other immune related dis-eases.

And then there is the need for zinc, but that's not a part of the study.

And, to counter the fallacious argument that all you have to do to get good nutrition is to eat a healthy diet, remember that food grown in low selenium soil is not healthy. Nor is that grown under stressful conditions with herbicides, pesticides, fungicides and fluoridated water.

Now you be the judge and I'd suggest you delve a bit deeper before accepting this story.

My observations are that these white coats are just asking the wrong questions.