Friday, February 22, 2008

Should cancer patients take vitamins?

Regarding the article “Should cancer survivors take supplements?” (14:34 ET, Thu 21 Feb 2008, http://features.us.reuters.com/wellbeing/news/FA7141DA-E0B3-11DC-91C7-1D7C8A14.html), I had written a rebuttal to a letter in CA: the Journal of the American Cancer Society, addressing these issues. (1) It is available on the journal’s web page, posted after editorial review. I cite numerous studies in which dietary supplements were used with cancer therapies, with no apparent problems. Additionally, since 40% of cancer patients actually die of malnutrition, please consider that it is wise to try to devise strategies to nourish the patients…they can’t live solely on chemotherapy and radiation, or surgery. Soon after, a review article addressed the same issue, reaching a similar conclusion: it is possible to mix dietary supplements with cancer therapies, in many cases improving results, though the timing is important. “CONCLUSION: None of the trials reported evidence of significant decreases in efficacy from antioxidant supplementation during chemotherapy. Many of the studies indicated that antioxidant supplementation resulted in either increased survival times, increased tumor responses, or both, as well as fewer toxicities than controls; however, lack of adequate statistical power was a consistent limitation.” (2) Science Daily reported that, “There is no evidence that antioxidant supplements interfere with the therapeutic effects of chemotherapy agents, according to a recent systematic review of the use of antioxidants during chemotherapy, available in the May, 2007 issue of the peer-reviewed journal Cancer Treatment Reviews. In fact, they may help increase survival rates, tumor response, and the patient’s ability to tolerate treatment.” (3) REFERENCES: 1. Cancer patients may very well tolerate the use of certain dietary supplements http://caonline.amcancersoc.org/cgi/eletters/55/5/319#176 2. Block KI, et al. Impact of antioxidant supplementation on chemotherapeutic efficacy: a systematic review of the evidence from randomized controlled trials. Cancer Treat Rev. 2007 Aug;33(5):407-18. Epub 2007 Mar 23. Review. PMID: 17367938 [PubMed - indexed for MEDLINE] 3. Antioxidants May Aid Chemotherapy Patients. ScienceDaily. Retrieved February 22, 2008, from http://www.sciencedaily.com/releases/2007/04/070426132954.htm Neil E. Levin, CCN, DANLA http://www.honestnutrition.com/

Monday, February 18, 2008

Response to inquiries about my credentials and independence

A couple of people have asked me to comment on other sites, or to refer to other sites, which I generally will not do. After all, this blog is an archive of my non-commercial writings, which are heavily referenced; so you may analyze and determine whether or not you think my scholarship and logic are valid, or not. I do not wish to comment on other people's sites; it is beyond the scope of my purpose. I think for myself and you can, too. Don't let self-appointed experts tell you what to think, unless you respect their scholarship, not just their arguments. That goes for believing me, as well! One writer has pointed out that the FDA does not approve supplements and pointed me to the agency's site, implying ignorance. If my blog entries were inspected more carefully, many references to the FDA's web site exist and in quite a bit more detail than the writer gave. Apparently the writer did not carefully consider my nuances of meaning while asserting that he/she was the expert. In fact, the agency requires all label claims ("structure-function" claims) to be submitted to them, allowing it to deny those claims, and then paradoxically requires all labels to say that the agency hasn't evaluated the claims. Kind of makes you think, no? It should! The agency also has to receive safety documentation for all new ingredients before they are sold on the market, but again does not explicitly approve them, though the absence of action to stop them does ring loud and clear. Again, the agency has plausible deniability, while retaining control. Yes, I do understand how the FDA works. Do you? One writer has persisted in questioning whether I work for and profit from vitamin companies. I do state in my bio that I am a vitamin formulator. But, you may notice that I scrupulously avoid mentioning any company names or endorsing them. If I were to post the comment, it would name names and could promote products. I am trying to maintain a professional detachment and tell the truth, as I see it. If I involve my clients/employers, I would not be able to have the freedom and independence necessary to "speak truth to power". But I write from the heart and do my own research. I formulate my own opinions as to the validity and accuracy of scientific and news reports, which I have done for decades. If you want to debate my conclusions and references, fine. But I assure you that my references are much more scrupulous and to the point than those of many of the published research I critique! THIS IS MY PERSONAL BLOG AND I WRITE PROFESSIONAL, WELL-REFERENCED TEXT ABOUT NUTRITION. NO ONE TELLS ME WHAT TO WRITE OR NOT WRITE. THIS IS NOT ABOUT PROFIT, "For what shall it profit a man, if he shall gain the whole world, and lose his own soul?" But my credentials and reputation do not substitute for you carefully dissecting my writings and my arguments. That is why I don't belabor their defense. The point is that people should realize that there are second opinions and not to rely on experts and authorities to tell us what to think. Yet I point out that the emperor has no clothes, and someone wants to know my tailoring credentials...seems like they kind of missed the point, doesn't it?

Unbalanced Fox news report misleads about vitamin-mineral safety

Unbalanced Fox news report misleads about vitamin-mineral safety By Neil E. Levin, CCN, DANLA I watched the special health report on vitamins and minerals on FOX-32 (How Do Vitamins and Minerals Really Affect Your Body? on 2/12/08, see link below), but was disappointed that the report exaggerated the risks of vitamins and minerals and minimized their benefits without any mention of the common deficiencies that exist in the American population. For example, the report cautioned about vitamin E causing blood thinning, but the Food and Nutrition Board of the Institute of Medicine has set an upper tolerable intake level (UL) for vitamin E (alpha-tocopherol) at 1,500 IU per day, which “is the highest dose unlikely to result in bleeding problems;” though the Institute has also said that the danger of the vitamin inhibiting clotting was not convincing. In other words, taking about four times the most common strength of even a hi-potency vitamin E capsule might be a problem in terms of affecting clotting, but this potency is higher than is available as a dietary supplement and one that people are unlikely to try without specific medical advice. Yet, somehow, the far more common danger of a vitamin E deficiency was completely ignored. This, despite the fact that, according to dietary data from the National Health and Nutrition Examination Surveys, ninety percent or more of the adults studied had usual intakes below the current Estimated Average Requirement. Why is a theoretical overdose problem even mentioned in the report, especially with no balancing mention of known deficiencies and benefits? What happened to fair and balanced reporting? And what are the benefits of vitamin E supplementation? An NIH-supported USDA -Tufts University study published in the medical journal JAMA reported, “…we observed a protective effect of vitamin E supplementation on upper respiratory tract infections, particularly the common cold,” for nursing home patients taking 200 IU of vitamin E daily. And Annals of the New York Academy of Sciences reported that, “The results of this clinical trial show that vitamin E supplementation significantly reduces the incidence rate of common colds and the number of subjects who acquire a cold among elderly nursing home residents.” Zinc was also mentioned in the FOX report as a possible overdose candidate, but levels required to reach the negative side effects mentioned are between 150-450 mg per day, again requiring a consumer to take several capsules to achieve this. The highest potency I have ever seen (in 35 years) was 75 mg, though 15-50 mg products are relatively common. Yet the median intake among American adults is just over 2/3 of the Daily Value, making deficiencies far more common than overdoses. Again, the FOX report ignored the common, greater danger in favor of sensationalizing a remote possibility of overdosing. Zinc is essential for many biochemical reactions in the body, and is most notably associated with immune function and wound healing. Yet isn’t FOX essentially warning people against taking zinc, hinting that they may be in danger but without any hint of the true risks and benefits? A dietician in the report stated that there is no proof that taking extra vitamin C shortens or prevents colds. That should come as news to the researchers at the University of Pittsburgh Medical Center. Publishing results of a Review Study in the medical journal American Family Physician in February 2007, these physicians reported that, “Thirty trials involving 9,676 cold episodes showed a statistically significant decrease in illness duration with vitamin C taken before onset of symptoms…. Likewise, 15 trials involving 7,045 cold episodes demonstrated a decrease in severity scores and in days confined to the home.” While there is some little evidence (not none) that vitamin C can prevent the incidence of colds, there is significant evidence that it can shorten the duration and severity of colds. Don’t you think that the FOX report is irresponsible by highlighting rare nutrient overdoses while ignoring common deficiencies? Also, why would one person’s opinion that vitamin C is worthless against colds trump the collective evidence of 30 clinical studies that met the strict criteria of a review study? Given these gross errors, I suggest that FOX assigns fact-checkers to review all medical and health reports. Let’s put an end to the flawed practice of naively taking the word of health professionals who appear not be up-to-date on what’s published in the medical literature. This is most important when demonstrably false blanket statements are made that inappropriately dismiss the safety and efficacy of essential nutrients that are known to be deficient in most Americans’ diets. REFERENCES: http://www.myfoxchicago.com/myfox/pages/Home/Detail;jsessionid=BF06BF0BCA71AE327C05A6BA65DEB517?contentId=5757535&version=2&locale=EN-US&layoutCode=VSTY&pageId=1.1.1&sflg=1 Vitamin E Fact Sheet NIH Office of Dietary Supplements Zinc Fact Sheet NIH Office of Dietary Supplements “Thirty trials involving 9,676 cold episodes showed a statistically significant decrease in illness duration with vitamin C taken before onset of symptoms: an 8 percent decrease (95% confidence interval [CI], 3 to 13 percent) in adults and a 13.5 percent decrease (95% CI, 5 to 21 percent) in children. Likewise, 15 trials involving 7,045 cold episodes demonstrated a decrease in severity scores and in days confined to the home. Vitamin C did not decrease the incidence of cold in the general population. However, a subgroup of six trials involving runners, skiers, and soldiers participating in subarctic exercises demonstrated a 50 percent relative reduction in the risk of developing a cold (95% CI, 32 to 62 percent).” Simasek M, Blandino DA. Treatment of the common cold. Am Fam Physician. 2007 Feb 15;75(4):515-20. Review. PMID: 17323712 [PubMed - indexed for MEDLINE]. Hathcock JN, et al. Vitamins E and C are safe across a broad range of intakes. Am J Clin Nutr. 2005 Apr;81(4):736-45. Review. PMID: 15817846 [PubMed - indexed for MEDLINE] Dial S, Eitenmiller RR. 1995. Tocopherols and tocotrienols in key foods in the U.S. diet. In: Ong ASH, Niki E, Packer L, eds. Nutrition, Lipids, Health, and Disease. Champaign, IL: AOCS Press. Pp. 327–342. Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids (2000). Institute of Medicine JASPREET K.C. AHUJA, JOSEPH D. GOLDMAN, and ALANNA J. MOSHFEGH. Current Status of Vitamin E Nutriture. Ann NY Acad Sci 2004 1031: 387-390. Erwin RB, et al. Dietary intake of selected minerals for the United States population: 1999-2000. Adv Data. 2004 Apr 27;(341):1-5. PMID: 15114720 [PubMed - indexed for MEDLINE] Meydani SN, et al. Vitamin E and respiratory tract infections in elderly nursing home residents: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):828-36. Erratum in: JAMA. 2004 Sep 15;292(11):1305. JAMA. 2007 May 2;297(17):1882. PMID: 15315997 [PubMed - indexed for MEDLINE] Meydani SN, Han SN, Hamer DH. Vitamin E and respiratory infection in the elderly. Ann N Y Acad Sci. 2004 Dec;1031:214-22. Review. PMID: 15753147 [PubMed - indexed for MEDLINE]

Wednesday, February 06, 2008

More about steroids and DSHEA

The fact that CNN removed the video and corrected its text report on DSHEA by substituting some of the original quotes with quotes from US regulatory agencies adequately confirms that my original criticism was both factual and confirmable. Make no mistake; it is currently illegal - under DSHEA - to put undeclared ingredients like steroids and steroid precursors in a dietary supplement. The fact that some outlaws have made supplements containing illegal drugs - without declaring them on their labels - is not a reflection on the legally operating dietary supplement industry; any more than a drug smuggler hiding contraband in a teddy bear is representative of all teddy bear manufacturers or a hollowed-out book is representative of all publishers. My contention is that steroids are often being deliberately and illegally added to “spike” certain dietary supplements, which are not "contaminated" in the sense that the substance was not accidently added. The addition of an undeclared active ingredient is "adulteration" under DSHEA, whether deliberate or accidental, and adulteration is quite clearly illegal. The FDA has full power to remove adulterated substances from the market under DSHEA and other laws; there is absolutely no legal protection for these unlawful “supplements”. It’s not a law’s fault if a government regulatory agency fails to vigorously enforce it, despite having clear authority in that area to act. Yet that’s precisely the kind of misdirected criticism that some critics of the industry propose: blaming weak enforcement on a perceived legal emasculation which simply isn’t there. This, despite the fact that the dietary supplement industry’s legislative allies have introduced bills to add funding to the FDA specifically so the agency could enforce DSHEA more strictly; which is additional proof that the industry does not avoid reasonable regulation and in fact prefers it to false claims of being “unregulated”. The Dietary Supplement and Nonprescription Drug Consumer Protection Act now requires all serious adverse events to be reported to the FDA within 15 business days. The supplement industry also supported this Act, knowing that it had to prove the safety of its products and show responsibility to the public and to lawmakers. The fact that supplement manufacturers supported the Anabolic Steroid Control Act of 2004 (HR 3886), banning androstene-type substances, should also reflect favorably on their commitment to responsible regulation and a desire to protect the public health. Even that has not quieted some critics. It is precisely an industry revulsion to outlaws posing as legitimate manufacturers that has repeatedly prompted industry support for additional government regulation. Industries do not typically request more regulation, so this stance should be more notable. Still, in my opinion it is illogical to blame a law for the actions of outlaws. Outlaws fill a perceived need at a high price, just like other drug dealers, but to consider their products to be accidentally “contaminated” is naïve, at best. Under authority granted to it by DSHEA, and after years of industry prodding, the FDA has only recently rolled out mandatory current good manufacturing practices (cGMPs), requiring safety and identity testing. There are a number of manufacturers already certified as operating under independently certified GMPs, giving consumers a high assurance against inadvertent contamination. Steroids and anabolic steroid precursors are currently regulated as prescription drugs. So no dietary supplement manufacturer has any legitimate, legal reason to use these controlled substances in any of their products, whether on or off the label, making accidental contamination quite implausible. The FDA has not claimed that DSHEA blocked its ability to regulate dietary supplements. Actually, several FDA commissioners have testified to Congress that they already had adequate enforcement powers under DSHEA; and that was before the introduction of additional regulation such as cGMPs, adverse event reporting, the anabolic steroid precursor ban, etc. It is irresponsible to continue to echo allegations that have already been disproved, taking on faith the word of cheaters who have been revealed and are trying to point the blame elsewhere. It’s ludicrous to try to shift blame on a law passed some 13 years ago, a law that specifically prohibits adulterated products. I think that the baseball player’s union leader successfully did just that, knowing that he had a receptive audience in a leading DSHEA critic. But the resulting publicity, repeating the tired old complaint of supplements being “unregulated”, does not constitute any form of real evidence, flying in the face of so many contrary facts. If you are still in doubt, don’t take my word for it. Please read the various pieces of legislation or check the websites of the regulating agencies and see for yourself. I have done both and base my writings solely on these demonstrable facts and reputable references, including official government agencies.