MLM StemTech Rebuttal of Stephen Barrett Claims

Response to Mr. Stephen Barrett of MLM Watch.org
and the National Council Against Health Fraud

Recently, people conducting an Internet search on “stem cell enhancer” were surprised to find an article by retired psychiatrist Stephen Barrett already raising doubts about StemEnhance and stem cell enhancers. We welcome this opportunity to provide you with further information on StemEnhance.

Barrett provides a relatively good background history of StemEnhance and StemTech HealthSciences (STHS). However he makes an inaccurate rapprochement between STHS and Cell Tech. STHS nor Desert Lake Technologies has NEVER been involved in any lawsuit about false claims. The work done by STHS and DLT is based on science, it is completely independent from Cell Tech, and all of our claims are solidly backed by science.

Barrett also claims that blue-green algae based products might contain dangerous toxins. (See below for reports on microcystin and neurotoxicity) There is no excuse at this point in time, nearly a decade after the industry has developed a stringent quality control program, to still repeat such irrelevant allegations. Whereas infection of beef by E.coli is still responsible for more than 20,000 intoxications and nearly 500 deaths every year, whereas aflatoxin in corn, peanuts, milk products, spices and other foodstuff have been responsible for several deaths, and whereas shellfish toxins are still responsible for several deaths every year, blue-green algae has been linked to no ill effect. Like any other food ingredient, if potential contaminants like heavy metals, pesticides, and shellfish toxins are present in quantity below levels established as safe, then the product is deemed safe. Stating that blue-green algae may be dangerous is akin to stating that eating a shrimp cocktail or a hamburger at your favorite restaurant is dangerous. Such a statement reflects a lack of scientific background and knowledge, or deceptive intent.

Barrett states that before taking any product, it is advisable to know whether it has been proven safe and effective for its intended purpose(s), and that with respect to StemEnhance, the following questions would have to be answered.

Questions posed by Barrett about Stem Enhance

1. What evidence shows that taking StemEnhance will improve anyone's health?
2. Has any study shown that people improved their health as a result of taking it?
3. What evidence shows that StemEnhance is safe for long-term use?
4. How can users be certain that long-term use will not cause abnormal tissue growth?
5. For whom is the product advisable?
6. Who should not take it?

1. What evidence shows that taking StemEnhance will improve anyone's health?

Numerous studies performed by various scientific teams throughout the world, including the National Institute of Health[1] have clearly established that the higher the levels of circulating stem cells the better the ability of the body to maintain optimal health. A recent publication in the New England Journal of Medicine[2] reported that the level of stem cells in the blood was one of the best indicators of cardiovascular health. Elevating the number of stem cells in the blood has been shown to improve health in many ways. [3-6] StemEnhance supports the release of stem cells from the bone marrow and increases the number of circulating stem cells by 25-30%, which is bound to assist the body in maintaining optimal health.

As Mr. Barrett must know, given his claimed experience with the FDA, that we cannot make any health claims linked to StemEnhance since it is a dietary supplement and not a drug. Our claims are limited to structure and function claims, which is what we have solidly documented. StemEnhance supports the natural release of stem cells from the bone marrow, thereby assisting the body in maintaining optimal health. We would be delighted to publish the single patient outcomes we have documented, but they could be construed as inferred health claims. Nevertheless, clinical studies are currently in progress involving specific organs and system to further document the mechanics of stem cell physiology, and these studies will be eventually published.

2. Has any study shown that people improved their health as a result of taking it?

Numerous empirical reports and testimonials testify to the health benefits of taking StemEnhance. Many companies have been shut down by the FDA because of inferred health claims linked to documentation of improvements with various diseases. We intend to maintain our message clearly within the boundaries of the Dietary Supplement Health and Education Act, and let StemEnhance speaks for itself. We would be delighted to provide Mr. Barrett with a few bottles of StemEnhance so he can see the benefits on his own health.

3. What evidence shows that StemEnhance is safe for long-term use?

AFA, the raw ingredient from which StemEnhance is derived, has been on the marketplace for more than two decades with a very good track record of safety. A safety study in mice determined that consumption of the equivalent of up to 2,000 AFA capsules daily led to no health problems at all. In fact, the authors claimed that the mice receiving the highest dose of AFA were less aggressive and looked healthier. StemEnhance is a 5:1 concentrate of AFA, and just like 5:1 concentrates of echinacea or grape seed or ginkgo or wheat grass juice that are as safe as the whole plant they are derived from, StemEnhance is as safe as whole AFA. StemEnhance is to whole AFA what carrot juice is to a whole carrot.

The question may also refer to the safety of increasing the number of circulating stem cells everyday by 25-30%. Here also the safety is unquestionable. The normal range for the number of circulating stem cells is between 1.2 and 5.0 stem cells per µL of blood. An increase of 30% in the number of circulating stem cells would at most mean an increase of 1.5 cells per µL, which is well within normal physiological range. Looking at this from a different angle, Krause et al. [7] reported that one single stem cell was enough to reconstitute the entire hematopoietic (red blood cell) and immune systems. If one single stem cell can do this, then the billions of stem cells left in the bone marrow after taking StemEnhance can maintain a healthy and strong bone marrow.

4. How can users be certain that long-term use will not cause abnormal tissue growth?

The release of stem cells from the bone marrow and their migration to tissues is a natural process that happens everyday. StemEnhance simply supports that natural process and tips the balance toward health everyday. StemEnhance does not do anything that the body does not already do everyday. So far, no instances of cancer or any similar problem have ever been observed when using in vivo natural release of stem cells from the bone marrow. Abnormal cellular growth has only been seen when manipulating stem cells in test tubes.

5. For whom is the product advisable?

Since StemEnhance supports the natural release of stem cells from the bone marrow, which is turn travel throughout the body to maintain the health of various organs and tissues. StemEnhance is the optimal daily support for the maintenance of optimal health. It is for everyone interested in giving their body an extra boost toward daily renewal of cells throughout the body. It is for anyone interested in supporting his or her body’s natural renewal system.

6. Who should not take it?

StemEnhance naturally contains a significant amount of vitamin K. Therefore, anyone taking anticoagulant medication should consult their doctor in order to adjust the medication, if necessary. StemEnhance could also be contraindicated for anyone having a disease of the bone marrow, though this is solely speculative and is not based on any observation of ill effect.

AFA contains phenylethylamine (PEA), known as the “molecule of love” or the “molecule of joy”. PEA is a natural compound made by the brain whenever one feels content, happy. Deficiency in PEA has been linked to problems of concentration and low mood, and oral intake of PEA has been shown to improve these conditions. StemEnhance concentrates PEA at about 5mg/g. PEA is responsible for the immediate feeling of well-being that one experiences after taking StemEnhance. Because of the effect of PEA in the brain, StemEnhance could be contraindicated for people suffering from severe manic depression.

Finally, Barrett states that “A few studies—most of them done in laboratory animals—have shown that circulating stem cells from bone marrow can develop into a few other types of mature cells. As far as I know, however, no study has demonstrated that increasing the number of circulating cells is safe or makes people healthier.” This is certainly the most eloquent expression of Barrett’s lack of expertise in this field.

Anyone interested to see if there are only “a few studies” showing that circulating stem cells can develop into “a few other cell types”, can simply do a search on Medline to see the thousands of article on that topic. Or simply refer to the study of Krause[7] in which bone marrow stem cells were seen to become functional cells of the skin, liver, colon, intestine, stomach, esophagus, kidney and lung. Bone marrow stem cells have also been documented to become brain cells,[8] heart cells,[1] muscle cells,[9] pancreatic cells[10]… virtually any cell type in the body. As to the second statement that to Barrett’s knowledge “no study has demonstrated that increasing the number of circulating cells makes people healthier,” one only needs to refer to the studies by Orlic at the NIH[1] and that of Werner et al.[2] Barrett could have done a simple search at the NIH library with the key words “circulating stem cells healing” (PubMed) and he could have avoided misleading people as he did.

I believe it is important for the sake of ethics and public integrity to end this discussion by putting these comments from Stephen Barrett, as well as all other comments by him, into a bigger context. Barrett is a retired psychiatrist who has not had many positive comments about dietary supplements and over the years has waged a little vendetta against anything that comes through any Network Marketing company. He would probably be against peanut butter if it were to be sold through an MLM. His attacks against natural approaches such as homeopathy and herbal medicine constituted a rather eloquent display of his ignorance.

He created the so-called National Council Against Health Fraud, which ironically is itself rather fraudulent and misleading, as it does not represent any objective and expert council, it does not represent any official national organization, and it provides rather biased information. Barrett claims to have several links with the FDA and a great expertise in FDA matter. We will let Judge Fromholz of the California Superior Court Case shed some light on Mr. Barrett. As stated by the Judge, Barrett’s motives appear to be more linked to personal financial gain than generous public education.

Below is an excerpt from Judges decision rendered against NCAHF 12/17/01 by Judge Framholz in California Superior Court. You can read the complete transcript, "A Judges View of the Quackbusters"

“Dr. Barrett was offered on several issues by the Plaintiff, but the Court found that there was substantial overlap on the issues that he and Dr. Sampson were asked to address. “Thus, in order to avoid duplicative or cumulative evidence (see Cal. Evidence Code §§ 352, 411, 723), Dr. Barrett's testimony was limited by the Court to the sole issue of FDA treatment of homeopathic drugs. The relevancy of this issue was questionable at best, since the Plaintiff had previously asserted that its case did not depend on or seek to establish any violation of federal food and drug laws or regulations. Nevertheless, Plaintiff elicited testimony from Dr. Barrett on his experience with the FDA as it relates to regulation of homeopathic drugs.

“Dr. Barrett was a psychiatrist who retired in or about 1993, at which point he contends he allowed his medical license to lapse. Like Dr. Sampson, he has no formal training in homeopathic medicine or drugs, although he claims to have read and written extensively on homeopathy and other forms of alternative medicine. Dr. Barrett's claim to expertise on FDA issues arises from his conversations with FDA agents, his review of professional literature on the subject and certain continuing education activities.

“As for his credential as an expert on FDA regulation of homeopathic drugs, the Court finds that Dr. Barrett lacks sufficient qualifications in this area. Expertise in FDA regulation suggests a knowledge of how the agency enforces federal statutes and the agency's own regulations. Dr. Barrett's purported legal and regulatory knowledge is not apparent. He is not a lawyer, although he claims he attended several semesters of correspondence law school. While Dr. Barrett appears to have had several past conversations with FDA representatives, these appear to have been sporadic, mainly at his own instigation, and principally for the purpose of gathering information for his various articles and Internet web-sites. He has never testified before any governmental panel or agency on issues relating to FDA regulation of drugs. Presumably his professional continuing education experiences are outdated given that he has not had a current medical license in over seven years. For these reasons, there is no sound basis on which to consider Dr. Barrett qualified as an expert on the issues he was offered to address. Moreover, there was no real focus to his testimony with respect to any of the issues in this case associated with Defendants' products.

“Furthermore, the Court finds that both Dr. Sampson and Dr. Barrett are biased heavily in favor of the Plaintiff and thus the weight to be accorded their testimony is slight in any event. Both are long-time board members of the Plaintiff; Dr. Barrett has served as its Chairman. Both participated in an application to the U.S. FDA during the early 1990s designed to restrict the sale of most homeopathic drugs. Dr. Sampson's university course presents what is effectively a one-sided, critical view of alternative medicine. Dr. Barrett's heavy activities in lecturing and writing about alternative medicine similarly are focused on the eradication of the practices about which he opines. Both witnesses' fees, as Dr. Barrett testified, are paid from a fund established by Plaintiff NCAHF from the proceeds of suits such as the case at bar. Based on this fact alone, the Court may infer that Dr. Barrett and Sampson are more likely to receive fees for testifying on behalf of NCAHF in future cases if the Plaintiff prevails in the instant action and thereby wins funds to enrich the litigation fund described by Dr. Barrett. It is apparent, therefore, that both men have a direct, personal financial interest in the outcome of this litigation. Based on all of these factors, Dr. Sampson and Dr. Barrett can be described as zealous advocates of the Plaintiff's position, and therefore not neutral or dispassionate witnesses or experts. In light of these affiliations and their orientation, it can fairly be said that Drs. Barrett and Sampson are themselves the client, and therefore their testimony should be accorded little, if any, credibility on that basis as well.”

References

[1] Orlic D, Kajstura J, Chimenti S, Limana F, Jakoniuk I, Quaini F, Nadal-Ginard B, Bodine DM, Leri A. & Piero Anversa. (2001) Mobilized bone marrow cells repair the infracted heart, improving function and survival. PNAS 98(18):10344–10349.

[2] Werner N, Kosiol S, Schiegl T, Ahlers P, Walenta K, Link A, Bohm M, Nickenig G. (2005) Circulating endothelial progenitor cells and cardiovascular outcomes. N Engl J Med. 8;353(10):999-1007.

[3] Bozlar M, Aslan B, Kalaci A, Baktiroglu L, Yanat AN, Tasci A. (2005) Effects of human granulocyte-colony stimulating factor on fracture healing in rats. Saudi Med J. 26(8):1250-4.

[4] Kong D, Melo LG, Gnecchi M, Zhang L, Mostoslavsky G, Liew CC, Pratt RE, Dzau VJ. (2004) Cytokine-induced mobilization of circulating endothelial progenitor cells enhances repair of injured arteries. Circulation. 110(14):2039-46.

[5] Eroglu E, Agalar F, Altuntas I, Eroglu F. (2004) Effects of granulocyte-colony stimulating factor on wound healing in a mouse model of burn trauma. Tohoku J Exp Med. 204(1):11-6.

[6] Tomoda H, Aoki N. Bone marrow stimulation and left ventricular function in acute myocardial infarction. Clin Cardiol. 2003 Oct;26(10):455-7.

[7] Krause DS, Theise ND, Collector MI, Henegariu O, Hwang S, Gardner R, Neutzel S, Sharkis SJ. (2001) Multi-organ, multi-lineage engraftment by a single bone marrow-derived stem cell. Cell 105:369-77.

[8] Eglitis MA and Mezey VA. (1997) Hematopoietic cells differentiate into both microglia and macroglia in the brains of adult mice. Proc. Natl. Acad. Sci. USA Vol. 94, pp. 4080–4085.

[9] Camargo FD, Green R, Capetenaki Y, Jackson KA, and Goodell MA. (2003) Single hematopoietic stem cells generate skeletal muscle through myeloid intermediates. Nature 9(12):1520-27.

[10] Ianus A, Holz GG, Theise ND, and Hussain MA. (2003) In vivo derivation of glucosecompetent cells from bone marrow without evidence of cell fusion. J. Clin. Invest. 111:843-850.