US natural health industry facing increasing censorship re health claims for selenium
By the ANH Team
Breaking news this week is that Bayer Healthcare (part of the Bayer Group) could face a lawsuit in the United States over claims on advertisements and labels for its One A Day Men’s multivitamins range that dare to suggest selenium may reduce the risk of prostate cancer.
‘Deceptive’ advertising and ‘insufficient science’
The US Consumer Advocacy Center for Science in the Public Interest (CSPI) has said that such claims are not backed by sufficient science and are deceptive. These accusations are based on the inherently biased, seven-year, $118m SELECT study funded by the National Institutes of Health, and the 1996 Nutritional Prevention of Cancer (NPC) trial. This latter study actually showed positive outcomes in cancer prevention, despite its own biases, so much so that the controls were unblinded part way through.
Not only is the CSPI threatening to sue if Bayer do not remove the claims in the ads, but it is also requiring Bayer (through the filing of a Federal Trade Commission (FTC) complaint) to run a corrective advertising campaign, because its ads have “for so long reinforced the false notion that selenium prevents prostate cancer”.
Selenium is currently the only mineral allowed to carry a US Food and Drug Administration (FDA) approved qualified health claim for general cancer reduction incidence:
“Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.”
Political censorship of scientific speech
A well-known Washington based lawyer, Jonathan Emord, who has been primarily responsible for approval of qualified health claims in the US, filed a petition with the FDA last year, requesting the use of qualified health claims for selenium supplements and reduced risk of specific cancers.
In its recent response to Emord, (as reported in NutraIngredients-USA.com) the FDA stated that it may allow the use of certain—“very qualified”—health claims linking selenium intake to reduced risk of bladder, prostate and thyroid cancer, but it rejected proposed claims for a reduction in risk of other site specific cancers.
The FDA described the credible scientific evidence for the cancer benefits as “very limited”, and therefore such claims would need significant qualifying language, e.g, the prostate claim would need to include the statement that selenium is “highly unlikely” to reduce the risk of prostate cancer.
ANH approached Jonathan Emord, for his personal comment. Emord said:
“These two decisions confirm that censorship reigns supreme in the Obama FDA. Brazenly, the Agency did not even cite, let alone apply, the standard of First Amendment review Judge Gladys Kessler commanded FDA to use in Whitaker v. Thompson I. Instead, FDA engaged in political censorship of scientific speech, discounting supporting evidence based on contrived arguments and exaggerating nonsupporting evidence to be the equal of contradictory evidence, which it was not. The federal courts mandated that FDA adopt the qualified health claims regime to remove FDA from the unconstitutional business of censoring speech concerning the potential of nutrients to affect disease risk. FDA has flouted that direction, has effectively reabsorbed the qualified health into the unqualified health claim regime, and has moved back to constitutionally infirm absolute censorship as its lode-stone for decision. FDA has become a court of star chamber. It views itself as above the law”.
The FDA’s paltry alternatives
These are the options proposed by the FDA:
“Prostate cancer: Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.
Bladder cancer: “One study suggests that selenium intake may reduce the risk of bladder cancer in women. However, one smaller study showed no reduction in risk. Based on these studies, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of bladder cancer in women.”
Thyroid cancer: “One weak, small study suggests that selenium intake may reduce the risk of thyroid cancer. Based on this study, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of thyroid cancer.”
Can you see the natural health industry clamouring to have these claims endorsing their products? Once again we see our freedom of speech curtailed despite a large body of scientific evidence in the peer review which would state otherwise.
Selenium – how essential is it?
Selenium is an essential trace element in our diet, and occurs naturally in our foods, particularly in Brazil nuts. It is an essential co-factor in many of our crucial enzyme reactions and metabolic processes. Via selenoproteins and selenoenzymes e.g, glutathione peroxidase, it’s involved in the regulation of thyroid hormones, in maintaining the integrity of tissues such as blood vessels and muscles and importantly, for the immune system.
There is an extensive body of evidence showing that selenium is vital for healthy function of the immune system and, contrary to recent bad press, for its cancer protective role. There is also evidence that lower dietary selenium intakes are associated with increased risk of prostate cancer, and that low serum levels of selenium are associated with prostate cancer, though some studies using lower levels of selenium supplements have yielded negative results. The methylated forms of selenium (e.g. selenomethionine) have been found to be the most active against tumours at intakes of 200 mcg per day.
Plants contain organic selenium primarily in the form of the amino acids, selenomethionine and selenocysteine and so it’s preferable to take these as supplementary forms if possible, rather than the inorganic forms like sodium selenite and sodium selenate.
This begs the question again: what forms and quantities of selenium have been used in the studies that yield negative or poor results? Are these studies being designed deliberately to fail?
How much is adequate?
Given that selenium is a mineral, how much ends up in our food supply is down to the quality of the soil that crops (especially wheat, pulses and animal feeds) are grown in as well as your consumption of meat and fish that may contain significant amounts of selenium. In Europe, a considerable amount of the dietary selenium consumed used to come from North American wheat imports, but during the 1980s, the Common Agricultural Policy dictated that EU wheat be preferred over imported wheat. This resulted in significant drops in selenium levels due to the naturally lower soil content in most parts of Europe. In addition to this, the negative impact of modern agriculture on the soil microflora (soil bacteria, which facilitate mineral uptake) has impacted the rate of uptake of what little selenium is left. The picture is similar with regard to the staple crop maize (corn) in many parts of Africa where Margaret Rayman has focused much of her research.
It is now apparent that for those living in selenium-deprived areas, selenium supplementation or fortification is essential if optimum intakes (100 – 200 mcg per day) are to be achieved. In areas where selenium-rich soils are prevalent, or where other sources of high selenium foods (e.g. imported brazil nuts) can be regularly consumed, supplementation will not necessarily be essential.
In the USA, for example, one-third of the population achieve intakes exceeding 122 mcg/day. By contrast, in the UK (and other parts of western Europe), selenium intakes have declined markedly over the last 20 or so years, with intakes averaging around 30-40 mcg/day, around half the recommended reference value.
However, please do remember that with selenium more isn’t necessarily better, given that long-term consumption of high dosages (in excess of 300 mcg daily) may cause selenosis and other serious adverse effects.