April 18, 2014

SUPPLEMENT Returns: Spring 2014 Edition now available

Posted in THE SUPPLEMENT - Newsletter of NYBC tagged , , , , at 1:19 pm by jarebe

SUPPLEMENT: Newsletter of the New York Buyers’ Club is back again and feeling the love - thanks to those who made our recent indiegogo campaign a success! All articles are archived here on our blog, or you can download the printer-ready version.

SUPP-APR2014-mini-cover

Click here to open the printer-ready version of SUPPLEMENT No.26

Dallas Buyers Club (The Movie) Meets New York Buyers’ Club (The Reality)

Some ask: Why do we need a buyers’ club, given that HIV meds have advanced so much in the past 20 years? What need does New York Buyers’ Club fill today?

New Research on Depression, and a New Look at Supplements for Mood & Sleep Disorders

New findings turn conventional wisdom on its head, suggest that insomnia can be a cause of depression rather than just a symptom or side effect

We Be JAMA! Report: Multivitamin + Selenium Slows Early-Stage HIV

The findings are especially relevant for early-stage HIV infection, where the combination proved its value in cutting risk of progression


Heartbleed Virus Concerns? NYBC’s Online Store Scores an “A” for Secure Shopping

Shopping online with us is both secure and private. See how we scored! (Link will open independent website testing/security site) You can also verify current SSL security from our site.


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Spring 2014 • Issue No. 26

 

April 9, 2014

New research on depression, and a new look at supplements for mood and sleep disorders

Posted in cognitive health, depression, DHEA, fish oil, GABA, green tea, melatonin, mental health, Omega-3, Probiotics, SAMe, sleep aids, St. Johns Wort, THE SUPPLEMENT - Newsletter of NYBC, theanine, Vitamin B12 at 10:02 pm by jarebe

At the end of 2013, there was much buzz about new studies showing that curing insomnia in people with depression might double the chance of a complete recovery from depression. The studies, financed by the National Institute of Mental Health, were welcomed as the most significant advance in treating depression since the introduction of the “selective serotonin re-uptake inhibitor” (SSRI), Prozac, twenty-five years ago. In effect, the new research findings turn conventional wisdom on its head, since they suggest that insomnia can be a main cause of depression, rather than just a symptom or a side effect, as previously assumed. If you can successfully treat a depressed person’s insomnia, according to the new view, you eliminate one of the main factors causing the depressed state.

New research findings turn conventional wisdom on its head
suggesting that insomnia can be a main cause of depression
rather than just a symptom or a side effect as previously assumed

As we followed reports on this breakthrough research on insomnia and depression, we were especially encouraged to read comments like the one from Washington DC psychiatrist James Gordon, who has advocated an integrative approach to treating depression. Here’s his letter to The New York Times: 

I welcome a new report’s finding that cognitive behavioral therapy is improving the outcome for depressed people with significant insomnia (“Sleep Therapy Seen as an Aid for Depression,” front page, Nov. 19). 

It reminds us that changes in attitude and perspective, and a therapeutic relationship, can right biological imbalances — like disordered sleep — and significantly enhance the lives of troubled people. The study also puts the therapeutic role of antidepressant medication in perspective: the depressed participants who received behavioral therapy did equally well whether or not they were taking the drugs. 

I hope that these results will encourage the National Institute of Mental Health, researchers, clinicians and all of us to expand our horizons. 

There are a number of other nonpharmacological therapies, including meditation, physical exercise, dietary change and nutritional supplementation, acupuncture and group support, that show promise for improving clinical depression and enhancing brain function.

At NYBC we have long believed that non-prescription therapies, such as supplements, are valuable alternatives for treating mood disorders and sleep disorders When the Centers for Disease Control surveyed use of antidepressant drugs in 2008, it found that one in 10 Americans was taking an antidepressant, and many had taken these drugs for years. Over a period of ten years, antidepressant use in the U.S. had shot up by 400%! So the question arises: how much of this spectacular increase represented real gains in treatment, and how much was over-prescribing? As Dr. Gordon mentions in his letter above, in some cases behavioral therapy for depression has worked just as well whether people were taking antidepressants or not—hardly a strong argument for the value of the prescription drugs.

A well-publicized 2008 report in the New England Journal of Medicine
found that pharmaceutical companies had consistently reported

only the most favorable trial outcomes for their popular antidepressants

A well-publicized 2008 report in the New England Journal of Medicine found that pharmaceutical companies had consistently reported only the most favorable trial outcomes for their popular antidepressants, passing over evidence that suggested a more limited effectiveness. Furthermore, as with many drugs, especially those used over a long period, antidepressants have side effects. Higher bone fracture risk and multiple cardiovascular risks have been identified; sexual side effects are common with antidepressants in both men and women; and withdrawal symptoms for those tapering off antidepressants include a long list of problems, such as panic attacks, insomnia, poor concentration and impaired memory.

Turning to the alternatives, we describe below supplements that NYBC has highlighted over the years for sleep and mood disorders. Note cautions about their use, but also note that some of these products may actually carry added benefits, rather than unwanted side effects.

1. Melatonin is a hormone occurring naturally in the body, but some people who have trouble sleeping have low melatonin levels. Melatonin has been used for jet lag, for adjusting sleep-wake cycles for people doing shift work on varying schedules, and for insomnia, including insomnia due to high blood pressure medications called beta-blockers. It is also used as a sleep aid when discontinuing benzodiazepines (Klonopin, Xanax, etc.) and to reduce side effects when quitting smoking.

2. Fish Oil. Epidemiologists have noted that populations that eat fish regularly have low rates of depression. And research has found that omega-3 fatty acids in fish oil supplements can be of benefit in treating depression and bipolar disorder. Fish oil can also be taken with other anti-depressants as an adjunct therapy. Doses found effective in treating depression are quite high, 3 to 9 grams per day, so be aware of potential problems related to the supplement’s blood-thinning properties. Added benefit: fish oil can help manage cholesterol, and supports cardiovascular health.

3. Deficiencies in the B Vitamins, especially B12 and folate, can result in neurologic symptoms — for example, numbness, tingling and loss of dexterity — and the deterioration of mental function, which causes symptoms such as memory loss, confusion, disorientation, depression, irrational anger and paranoia. A number of studies have shown that vitamin B12 is deficient in a large percentage of people with HIV, and the deficiency can begin early in the disease. Supplementing with a B complex protects against deficiency and supports cognitive health and mental function.

4. Vitamin D deficiency has also been linked to depressed states. Lack of the “sunshine vitamin” may be especially associated with Seasonal Affective Disorder (SAD), the “winter blues.” Vitamin D also supports bone health, and may protect against colds and flus.

5. Theanine, an amino acid found in green tea, acts as a relaxing agent by increasing levels of certain neurotransmitters (=brain chemicals that shape your mood), including serotonin, dopamine, and GABA (gamma amino butyric acid). Human studies have been limited to date, but one small study showed that theanine decreases stress responses such as elevated heart rate. Another investigation compared theanine’s calming effect to that of a standard anti-anxiety prescription drug, and found that theanine performed somewhat better. Note that NYBC stocks Theanine Serene (Source Naturals), a combination supplement that includes theanine and GABA.

6. Probiotics. Very recent research has looked into the communication between the digestive system and the brain, with a goal of understanding how gut health may influence chronic conditions, including mood disorders like depression and anxiety. For example, it has been shown that certain probiotics promote production of the calming, anti-stress neurotransmitter GABA in the body, pointing to a direct influence of probiotics on mood. Other potential links between the gastrointestinal system’s microorganisms and brain function are currently being explored.

7. L-Tryptophan and 5-HTP (5-hydroxy L-tryptophan). These closely related supplements are converted in the body to serotonin and to melatonin. (Take L-tryptophan with carbohydrates to make it effective.) Their use as antidepressants has been studied, and they have also been found to aid sleep and suppress appetite. (To minimize appetite suppression, take the supplement an hour before bedtime.)  Although L-Tryptophan and 5-HTP are close relatives, people may respond somewhat differently to them, so it may be worthwhile to try the other if the first doesn’t produce an effect An added benefit: 5-HTP may also decrease symptoms of fibromyalgia and migraine headaches.

8. In research funded by the National Institute of Mental Health, DHEA (dehydroepiandrosterone) was found to be an effective therapy for mild-to-moderate or severe midlife depression, on par with some prescription drugs. Moreover, the research showed that taking DHEA promoted both a significant lifting of depressive symptoms and an improvement in sexual functioning. Note that dosing recommendations vary for men versus women, and DHEA is not recommended for those diagnosed with prostate conditions or cancer.

9. SAMe (S-adenosyl-l-methionine) is produced naturally in the body from the amino acid methionine. Supplementing with SAMe increases concentrations of the neurotransmitters serotonin and dopamine. Several studies show SAMe having an antidepressant effect comparable to that of some prescription drugs. SAMe should be avoided in people with bipolar disorder, and should be used cautiously with other antidepressants, because the combination may push serotonin levels too high. Taking a B-complex vitamin while using SAMe can counter build-up of homocysteine, which has been linked to heart disease SAMe may also support joint health and liver function. Caution: the National Center for Complementary and Alternative Medicine has posted a warning that SAMe may increase likelihood of pneumocystis infection in immune-compromised people. Note: see also Trimethylglycine (TMG), which includes the raw materials that the body uses to manufacture SAMe. TMG is much less expensive than SAMe.

10. St. John’s Wort is a widely used herb with clinically demonstrated (multiple, well-controlled studies, mostly in Europe) anti-depressant effects for mild to moderate depression – generally without the side effects of prescription antidepressants. High doses of the herb may cause a sensitivity to light (phototoxicity), so avoid direct sunlight or sunbathing while using. Do not take St. John’s Wort with 5-HTP, serotonin re-uptake inhibitors (like Prozac), or with protease inhibitors, as it may affect beneficial liver enzymes. St. John’s Wort may also have activity against Epstein-Barr and herpes infections.

11. Finally, we’ll mention another combination supplement that NYBC has stocked: GABA Soothe (Jarrow). The GABA in this supplement is the neurotransmitter that promotes calmness coupled with mental focus. Also included is theanine (see above for a description of its anti-anxiety effects) and an extract of ashwagandha, an herb which has long been used in the Ayurvedic tradition of India to reduce fatigue and tension associated with stress.

 

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This article from the Spring 2014 edition of SUPPLEMENT: Newsletter of the New York Buyers’ Club, available for download at http://www.NewYorkBuyersClub.org

 

References:

CDC statistics on antidepressant use in the US, 2005-2008: http://www.cdc.gov/nchs/data/databriefs/db76.htm

Turner, E et al. Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy. New England Journal of Medicine,  2008; 358:252-260 January 17, 2008 doi: 10.1056/NEJMsa065779

Logan, A.. Omega-3 fatty acids and major depression: A primer for the mental health professional. Lipids Health Dis. 2004; 3: 25; doi:  10.1186/1476-511X-3-25

Sudden cardiac death secondary to antidepressant and antipsychotic drugs, Expert Opinion on Drug Safety, March 2008; 7(2):1081-194

Alramadhan E et al. Dietary and botanical anxiolytics Med Sci Monit. 2012 Apr;18(4):RA40-8.

Rogers PJ, Smith JE, Heatherley SV, Pleydell-Pearce CW. Time for tea: mood, blood pressure and cognitive performance effects of caffeine and theanine administered alone and together. Psychopharmacology (Berl) 2008;195(4):569–77.

Kimura, K et al. L-Theanine reduces psychological and physiological stress responses. Biol Psychol. 2007 Jan;74(1):39-45.

National Center for Complementary and Alternative Medicine at NIH. S-Adenosyl-L-Methionine (SAMe): An Introduction Accessed at http://nccam.nih.gov/health/supplements/SAMe

Carpenter, D J. St. John’s wort and S-adenosyl methionine as “natural” alternatives to conventional antidepressants in the era of the suicidality boxed warning: what is the evidence for clinically relevant benefit? Altern Med Rev. 2011 Mar;16(1):17-39.

Foster, J A et al. Gut-brain axis: how the microbiome influences anxiety and depression Trends in Neuroscience. 2013 May;36(5):305-12. doi: 10.1016/j.tins.2013.01.005.

Rao, A V & Bested, A. A randomized, double-blind, placebo-controlled pilot study of a probiotic in emotional symptoms of chronic fatigue syndrome. Gut Pathog. 2009; 1: 6 doi:  10.1186/1757-4749-1-6

March 24, 2012

ThiolNAC is Back – and Remixed!

Posted in THE SUPPLEMENT - Newsletter of NYBC at 6:23 pm by jarebe

ThiolNAC, custom-manufactured and available exclusively through New York Buyers’ Club, is back in stock after our recent and successful fundraising campaign – thank you!

ThiolNAC is a combination of two powerful agents: N-Acetyl-Cysteine (NAC) and Alpha-Lipoic Acid (ALA). Recently reformulated, three ThiolNAC tablets per day now provide the same exact dose of these key antioxidants, used in Dr. Jon Kaiser’s groundbreaking 2006 study of HIV-positive patients undergoing antiretroviral therapy (ARV), which proved that a combination of micronutrients (vitamins, minerals, and trace elements) and antioxidants could boost CD4 counts (24%, on average). This formula subsequently became the basis for the very popular K-PAX®.

With our new supply of ThiolNAC, the New York Buyers’ Club continues to offer a supplement combination of quality comparable to K-PAX named NYBC MAC Pack (for Multivitiamin-Antioxidant Combintation) – at less than half the price.

Price Comparison: NYBC MAC Pack vs K-PAX

About NAC and ALA

Data show the benefits of NAC in conditions ranging from pulmonary problems to possibly reducing the potential for cancer cells to metastasize. Notably, NAC is effective in replenishing the body’s glutathione (sometimes called the “master antioxidant,” responsible for counteracting many damaging inflammatory processes). Individuals with HIV and other chronic infections often see a reduction in glutathione; by working to replace lost glutathione, NAC may help slow disease progression and lessen some medication side effects, particularly if used as part of a comprehensive plan for managing such symptoms and side effects (read: plays well with others!).

Alpha-lipoic acid (ALA) is a liver protective agent, and has been studied for peripheral neuropathy and lipodystrophy. It may slow HIV replication, and counter HIV-related dementia. ALA is very important in several ways. It easily crosses cell membranes and works as anantioxidant in both lipid (fatty) and aqueous (watery) parts of the body. It is a versatile and powerful antioxidant, both reducing oxidative stress in the body, and indirectly protecting, recycling, or regenerating other major antioxidants.

There is also good evidence that ALA has beneficial effects for those with type 2 diabetes and some of its complications. Its wide-ranging benefits for diabetes, according to recent research, include improved glycemic control, improved insulin sensitivity, as well as reduction of oxidative stress and neuropathy.

Caution

Our colleague Lark Lands, an expert on supplementation for people with diabetes and people with HIV, has drawn our attention to the concern that alpha lipoic acid may produce symptoms of hypothyroidism in some people. Partly due to this concern, NYBC has also reduced ALA in our ThiolNAC, such that 3 tabs/day equals 400mg – below the dosages generally of concern in Lark’s analysis. Symptoms of hypothyroidism may include fatigue, low body temperature, weight gain, hair loss, splitting fingernails, depression, memory problems, muscle weakness, elevated cholesterol, and/or skin that is dry, rough or scaly. NYBC recommends monitoring the thyroid while taking ThiolNAC or ALA by itself. For more on ALA and the thyroid, click here.

August 26, 2011

Instead of Overly Restrictive Rules, Can We Please Have More Useful Research and Education on Supplements from our Federal Agencies?

Posted in FDA, hepatitis, HIV, liver disease, THE SUPPLEMENT - Newsletter of NYBC tagged , , at 4:35 pm by jarebe

The New York Buyers’ Club Co-Op’s Treatment Director advocates for more useful research on supplements from the federal government, and shares his long expertise and personal experience in managing liver health with supplements:

Instead of Overly Restrictive Rules, Can We Please Have More Useful Research and Education on Supplements from our Federal Agencies?

The Food and Drug Administration (FDA) recently released a proposed new rule, which many believe could unnecessarily restrict consumer access to supplements introduced after 1994. (Access to supplements on the market before 1994 is generally protected by the Dietary Supplements Health and Education Act, passed that year.)

Perhaps the greatest concern is the form of vitamin B6 known as pyridoxal- 5′-phosphate or P5P. (Used for example, in the MAC-Pack, NYBC’s low-cost alternative to the K-PAX multivitamin/antioxidant combination for people with HIV.) There has been a concerted effort by pharmaceutical companies over the years to turn this vitamin into a drug, thus restricting access to it, and likely raising the price.

Overall, it is unclear what benefit the proposed new FDA rule would have for supplement users—if any. Certainly we believe there is much the FDA can do for consumers, including a robust program to test supplements for identity, potency and purity and broadcast the results quickly and widely. And, turning to the major health research agency of the federal government, we would welcome the National Institutes of Health (NIH) conducting more clinical trials to assess benefits and limitations of supplements. This type of research can answer important clinical questions and truly help consumers.

I am living with hepatitis C and without health insurance, and have relied on diet, lifestyle changes and supplements—identified through years of personal research–to normalize my liver enzymes, slow disease progression and keep my viral load fairly low while I try to enroll in a clinical trial. * Why can’t our federal agencies promote more research on supplement combinations like the ones I have used and circulate useful knowledge about the results, rather than wasting resources on restricting access to widely used supplements like the form of vitamin B6 mentioned above?

George Carter

*You can find a pocket guide to my recommendations for using supplements for liver health in NYBC’s Summer 2010 Supplement Special Issue, 50+ Ways to Love Your Liver.

You can also find a library of other useful guides to using supplements to maintainn and improve your health at NYBC’s SUPPLEMENT Archive Page:

http://newyorkbuyersclub.org/supplement/index.html

January 31, 2011

Supplements for Liver Health

Posted in alpha lipoic acid, hepatitis, Hepatoplex, liver disease, silymarin, THE SUPPLEMENT - Newsletter of NYBC, Traditional Chinese Medicine tagged , , , , , , , at 1:19 pm by jarebe

NYBC has published an online guide to Liver Health, which you can access at

SUPPLEMENT No. 17 Summer 2010

Liver Health

And, yes! You’ll find liver healthy supplements like silymarin, alpha lipoic acid and Chinese herbal formulas, all described in detail with usage recommendations in a special section of the NYBC catalog pages:

http://nybcsecure.org/index.php?cPath=57

November 20, 2010

Regulatory Issues: The Long Version

Posted in THE SUPPLEMENT - Newsletter of NYBC at 8:02 pm by jarebe

Supplements and Regulations

The FDA is going to ban all supplements! The Codex Alimentarius is going to cause supplements to be prescription-only here in the U.S.! Supplements are horribly dangerous! Supplements have no physiologic effects whatsoever!!

Sorting through the truth about what supplements can do, how and when they can help and what the laws are all about regarding them is no easy task. Pools of interested parties compete for our attention. The manufacturers and purveyors of dietary supplements resist regulation. Some trade organizations, such as the Council for Responsible Nutrition accept the need for some regulation (e.g., for quality products and ethics). By contrast, some in the government and some consumer advocate organizations would like to place heavy restrictions upon them and even deny access altogether (e.g., to herbs considered dangerous, such as chaparral, comfrey and others). Yet others, notably in the drug industry, fear their potential to compete with highly profitable, costly and often toxic drugs.

So who to believe? There is yet another pool of interested people. Those of us who USE these interventions: the consumer. Here at NYBC, we are living with chronic diseases such as HIV, hepatitis C, chronic fatigue, Lyme disease, among others, not to mention the simple fact we’re all getting older. So while we sell supplements, we do so both as a non-profit and as people living with chronic disease. Where vitamin stores may try to get you to buy more and more, we are more interested in understanding if, when, how and why to use supplements to manage health, offset side effects all while trying to assure it fits in your budget. Is it a help? Is it a waste of time? And for this article—is the very access to supplements under threat?

Basics
The term dietary supplements has a specific meaning within the laws and regulations of the Food and Drug Administration (FDA) of the United States government. By the FDA definition, a dietary supplement “is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.” Further, it:
• is intended for ingestion in pill, capsule, tablet, or liquid form.
• is not represented for use as a conventional food or as the sole item of a meal or diet.
• is labeled as a “dietary supplement.”
• includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).

Regulations for dietary supplements were carved out in legislation known as the Dietary Supplement Health and Education Act of 1994 (DSHEA) that President Clinton signed into law in 1994. It was an amendment to the 1938 Federal Food, Drug and Cosmetic Act, which gave FDA the authority to evaluate the safety and efficacy of a range of products on the market. The provisions of DSHEA define dietary supplements and dietary ingredients; establish a new framework for assuring safety; outline guidelines for literature displayed where supplements are sold; provide for use of claims and nutritional support statements; require ingredient and nutrition labeling; and grant FDA the authority to establish good manufacturing practice (GMP) regulations. The law also requires formation of an executive level Commission on Dietary Supplement Labels and an Office of Dietary Supplements within the National Institutes of Health. (Source: http://www.cfsan.fda.gov/~dms/dietsupp.html, 3/7/2006).

Current Efforts to Reform/Amend DSHEA
Often, we hear that dietary supplements live in some kind of wild west of no regulations and freewheeling. This is inaccurate. Indeed, the DSHEA gives FDA numerous opportunities to oversee what is on the shelf—but they have failed to do so. To the extent that FDA exerts such powers, it has been largely to go after supplement companies who make claims that a product can affect a disease condition. We look at this more in a moment.

One widely-shared concern about ALL products is quality, including:
Identity – it is what it says it is;
Purity – it doesn’t have adulterants or contaminants (and the label FULLY explains all ingredients)
Potency – it has the amount claimed (i.e., 500 mg of acetyl-L-carnitine, not 425 or 900)

On FDA’s website, they note
Does FDA routinely analyze the content of dietary supplements?
In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. …

In other words—they COULD be evaluating supplements—but they’ve never bothered to lobby Congress for the funds, equipment and people-power to do so! Why not? This is the kind of jobs creation America needs! This is the kind of effort that will assure that our food, dietary supplements AND drugs are in what they say they are and excellent quality. THIS is how it would be nice to see our tax dollars spent; employing more people to do the good work of assuring the safety and quality of the products we consume, that our very LIVES depend upon!

Once the product is in your hands and you are consuming it, other aspects come into play, including Safety, Bioavailability and Efficacy. Safety refers to the potential for ANYTHING one consumes to cause problems. A drug like AZT can have a range of side effects. And a peanut can be lethal if you have an extreme allergy. For the most part, dietary supplements are much safer than over-the-counter medications, though problems may arise if too much is used (e.g., high doses of selenium are toxic); it may have side effects (as mild as GI upset to liver toxicity) or it may interact with medications (like St. John’s wort).

FDA has developed a system to enhance reporting of adverse events related to a dietary, but it is a passive effort. If you think a supplement has caused some kind of negative effect, you and/or your physician may report this. While for the most part, the potential for side effects is pretty well understood for the majority of dietary supplements (as they are defined at the outset, from historical empiric observation, to be Generally Recognized As Safe (GRAS)), some newer agents and even older ones may present with hitherto unobserved effects. Understanding the complete range of potential side effects is critical to making a rational assessment of therapeutic options. That doesn’t mean something should be removed from the market. For example, people with peanut allergies can face death and, understanding their risk, assiduously avoid peanuts. Those that can consume them safely may continue to do so. In the meantime, it remains unclear how robust this new system is or how it is working.

Bioavailability refers to how well one’s body absorbs the substance or, in the case of a botanical (or “herb”), some active constituents. Efficacy is whether it does what it claims to do. It’s that “claim” bit that gets regulators in a tizzy—and also some in the pharmaceutical industry who view with some considerable agitation the potential threat that any competition represents to their profits.

Claims about the effect of a dietary supplement are limited to “structure and function.” For example, one can talk about vitamin D3 and calcium sustaining bone strength. Any such claims on an effect on structure or function must be accompanied by a statement prescribed by DSHEA, one you have no doubt seen many times: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

By contrast, claims about Efficacy to treat, mitigate or cure a disease are forbidden without the FDA’s approval. This approval can only be undertaken should the supplement be classified as a drug and undertake all the onerous and costly steps of new drug approval, including extensive clinical trials. The “wild west” that we live in is one where pretty much only for-profit companies (and the hospitals, physicians and clinics they buy), can bring a drug to market. If the drug is one for which there is no exclusivity of a patent, they cannot “corner the market” (and extract whatever price “the market will bear”) for that product. This horrifying state of affairs has resulted in clinical trials for pharmaceutical drugs being degraded into mere tools for marketing rather than a robust approach to evaluating the benefits, limits and risks of any intervention, let alone outrageous pricing.

Should a company decide to advertise a supplement (or food) has a benefit, say for lowering cholesterol, the Federal Trade Commission (FTC) may get into the act, along with the FDA. In many cases, this is undoubtedly a legitimately used tool to address some of the outrageous claims made about some dietary supplements. However, the agency has also gone after companies who have provided scientific support for an intervention’s efficacy. This is the risk and the constant battle.

Unfortunately, with either structure/function claims or efficacy, the FDA has basically done little since DSHEA was enacted in 1994. There are only a few approvals of efficacy for supplements or structure/function claims have been made in the past 16 years. We urge FDA to develop a mechanism and methodology to assemble experts to evaluate the literature and make approvals of claims in a timely fashion.

Robust rulemaking for complete transparency regarding any potential conflicts of interest for government employees is of course critical to assuring public trust. Such rules exist but are haphazard and relatively weak—we’ll consider them in another piece. This can be compromised by the revolving door from government into industry and the noxious influence of industry insiders writing self-serving legislation. A fascinating list of officials who moved into highly lucrative private companies may be found by clicking this sentence.

New Legislation
The Senate Food Safety Modernization Act bill (S.510) and its companion House bill HR875 is essentially designed to address issues arising out of incidents like the recall of billions of eggs in the summer of 2010 for salmonella contamination, among other issues (such as E. coli contaminated spinach and so on). It would amend the Federal Food, Drug, and Cosmetic Act and provide regulators with the capacity to punish offenders with increased fines and prison sentences of up to 10 years. It has yet to be voted upon as of early November, 2010. [You can read the Summary here http://www.govtrack.us/congress/bill.xpd?bill=s111-510&tab=summary as well as the full text.] Part of the issue here is that it is being merged with language from S.3767, Senator Patrick Leahy’s original bill. S.510 essentially had exempted dietary supplements from the purview of the bill, but the original Leahy bill did have relevant language.

The Bill may have an impact on organic farmers by requiring potentially duplicative oversight. On the other hand, potentially onerous user fees have been rejected. Other more legitimate criticisms with regard to food are articulated by Organic Consumers organization. While a complaint that some of the bill’s language may be onerous for smaller businesses to fully comply with, by contrast, the need for assuring safe and pure products is unquestioned and in principle we support the bill. There are concerns all over the internet that the bill would prohibit any growing of anything from seeds and sharing food from your garden without federal oversight. This is simply right-wing hysteria and outright lies.

With regard to dietary supplements, the problems have been to what degree FDA may be given powers that are beyond the law’s intended purview—the language of the bill may sound good but the devil is in the interpretation. For example, the Leahy bill includes language that would seek jail terms for people who knowingly or recklessly adulterate or misbrand products. Which sounds eminently reasonable! What would not be so reasonable is if FDA were to interpret this to mean they have latitude to threaten imprisonment to anyone who cited scientific literature to discuss a product as a form of “misbranding.” Thus, the concerns turn on the precise definitions of “misbranding” and “adulteration” which some view as potentially being distorted by overly FDA zealous officials to use the law and its threat of incarceration to cow anyone who would dare share scientific data that underscores a therapeutic effect.

The definitions for these terms are found in the Food, Drugs and Cosmetics Act, specifically Sec. 403 [21 USC §343] Misbranded Food and 402 [21 USC §342] Adulterated Food. Each of these has specific language for dietary supplements. Misbranding means that a product is not what it says it is. To comply with the law, a label must have certain information that should reflect the actual contents, including:

(s) Dietary supplements.
If—
(1) it is a dietary supplement; and
(2)(A) the label or labeling of the supplement fails to list—
(i) the name of each ingredient of the supplement that is described in section 201(ff); and
(ii)(I) the quantity of each such ingredient; or
(II) with respect to a proprietary blend of such ingredients, the total quantity of all ingredients in the blend;
(B) the label or labeling of the dietary supplement fails to identify the product by using the term “dietary supplement”, which term may be modified with the name of such an ingredient;
(C) the supplement contains an ingredient described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived;
(D) the supplement—
(i) is covered by the specifications of an official compendium;
(ii) is represented as conforming to the specifications of an official compendium; and
(iii) fails to so conform; or
(E) the supplement—
(i) is not covered by the specifications of an official compendium; and
(ii)(I) fails to have the identity and strength that the supplement is represented to have; or
(II) fails to meet the quality (including tablet or capsule disintegration), purity, or compositional specifications, based on validated assay or other appropriate methods, that the supplement is represented to meet.
A dietary supplement shall not be deemed misbranded solely because its label or labeling contains directions or conditions of use or warnings.

(t) Catfish. 6 If it purports to be or is represented as catfish, unless it is fish classified within the family Ictaluridae.

With regard to adulteration:
(f) Dietary supplement or ingredient: safety.
(1) If it is a dietary supplement or contains a dietary ingredient that—
(A) presents a significant or unreasonable risk of illness or injury under—
(i) conditions of use recommended or suggested in labeling, or
(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use;
(B) is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;
(C) the Secretary declares to pose an imminent hazard to public health or safety, except that the authority to make such declaration shall not be delegated and the Secretary shall promptly after such a declaration initiate a proceeding in accordance with sections 554 and 556 of title 5, United States Code, to affirm or withdraw the declaration; or
(D) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.
In any proceeding under this subparagraph, the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis.
(2) Before the Secretary may report to a United States attorney a violation of paragraph 4 (1)(A) for a civil proceeding, the person against whom such proceeding would be initiated shall be given appropriate notice and the opportunity to present views, orally and in writing, at least 10 days before such notice, with regard to such proceeding.

(g) Dietary supplement: manufacturing practices.
(1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by the Secretary under subparagraph (2).
(2) The Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology. No standard of current good manufacturing practice may be imposed unless such standard is included in a regulation promulgated after notice and opportunity for comment in accordance with chapter 5 of title 5, United States Code.

Interestingly, the definition of adulteration allows specific exclusion for pesticide chemical residue on unprocessed or raw agricultural items, food and color additives as well as new animal drugs (like meat filled with antibiotics).

Specifically, one trade industry group, the Alliance for Natural Health says, “the FDA contends that any food or supplement producer who mentions the potential of a product to prevent or treat disease is guilty of misbranding—even if they have piles and piles of scientific research from Harvard or some other top institution. So this bill would create a potential ten-year jail term simply for citing the best science.” There is a clear distinction between misbranding that is outright fraudulent (i.e., selling black cohosh that is actually lawn clippings) and good faith efforts to provide information about the relative scientific merits of a potentially therapeutic effect. Clearly, if a manufacturer sells products with adulterants in it or made out of grass clippings, we say “nail ‘em!” But good faith efforts to discuss scientific evidence should not be prosecuted with threats of jail time if there is a good faith effort to provide clear references to scientific data. UPDATE: It appears the Food Safety Law passed WITHOUT the onerous prison sentences…

A good overview of the various US government agencies, including the USDA, FTC and Dept. of the Treasury, that oversee food to assure it is not adulterated or misbranded is here.

Overall, we at NYBC support the Food Safety bill, particularly if language can be added that clarifies that FDA should not abuse its authority or waste precious resources on assaulting legitimate efforts to sustain our health. Indeed, we support a positive role of government in weeding out and, where necessary, prosecuting the unscrupulous. As noted, we advocate significantly increased resources for FDA to set up labs around the nation to routinely evaluate dietary supplements found on the market, publishing ALL data and findings transparently on a website and issuing alerts for products found to be inadequate or adulterated or also if they passed the tests.

The International Situation
Laws affecting what we here in the US refer to as dietary supplements vary from nation to nation. We will touch on a few of concern to people living with chronic diseases, but a more complete survey is beyond the scope of this article.

In Europe, member nations of the European Union are having their laws harmonized with respect to a wide range of policies. The two main pieces of legislation we briefly review here are the Codex Alimentarius and the Traditional Herbal Medicinal Products Directive (THMPD).

The Codex is “a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety” (For more info, click here). Overall, the general principles of assuring food safety are sound and important. However, a fly in the ointment arose when a delegation from Germany insisted that dietary supplements should be reclassified as drugs. This happened in 1996 and while it was agreed to, loud protest halted its implementation. In 2005, “Guidelines for Vitamin and Mineral Food Supplements was adopted by the Commission. These guidelines were ostensibly meant to help prevent people from overdosing on vitamins, claims the UN’s Food and Agriculture Organization (FAO) and to assure the product safety. (Obviously, in nations with robust, comprehensive healthcare for all, getting a prescription and having it covered under the national health program would be a boon in some respects. We don’t have that here so we argue that if you’re going to start harmonizing, we should have a) health care for EVERYONE, b) access to providers informed about the use of dietary supplements and c) complete coverage.)

To the extent that this concern is true, it is rational. To the extent that these Guidelines may serve as a stepping stone to more restrictive laws that prohibit access to supplements, we object. Each EU nation is grappling with this—but sadly, it would appear that science is left in the lurch, as are we who are trying to survive and thrive despite chronic disease.

In the United States, there is a concern expressed by many that the Codex will somehow affect access to supplements by forcing us to change our laws to “harmonize” with the Codex Guidelines. One consumer protection group, the Center for Science in the Public Interest, has analyzed the potential and points out ways in which the Guidelines may be addressed in a June 1997 report. This group sees Codex as potentially diluting some of the more stringent standards in the US (e.g., for bottled water). By contrast, CSPI supports MORE restrictive laws for dietary supplements. Interestingly, they note that “The U.S. delegation told the Committee that herbal medicines in the U.S. are regulated as dietary supplements pursuant to the DSHEA, and need not be reviewed for safety or approved by the FDA prior to marketing. The U.S. delegation, however, did not fully inform the committee about the difficulties that the FDA has had trying to restrict the sale in the U.S. of harmful herbs such as ephedra, chaparral, comfrey, and other substances.” This hardly paints a picture of an overly draconian FDA! (By contrast, as with substance like tobacco and alcohol, restricting the sale of substances should not be in the purview of the government. Assuring adequate labeling to identify risks is what is important. Ephedra is safe in normally used doses for most people; athletes or others who use excessive doses do so at their own risk…as people do when they smoke, drink, bungee jump, etc. Prohibition may be good for the prison industrial complex but it doesn’t solve anything. However, not all of us at NYBC agree with this idea and some feel that FDA has a duty to restrict sales of harmful products…yet, while tobacco has fallen under their purview in recent years, and cigarettes clearly kill, they remain for sale…but the topic is clearly controversial!)

A second area of concern is the Traditional Herbal Medicinal Products Directive (THMPD), destined to become law on April 1, 2011. This EU law was designed explicitly to address the use of botanical agents, requiring “herbs” have licenses in order to be sold on the market. While it has relatively successfully been able to evaluate and license many European botanical agents, it has left aside botanicals from other nations—and thus the benefits of entire realms of healing knowledge as reflected in the systems of Chinese medicine and Indian traditional systems of medicine like Ayurveda, Siddha and Tibetan medicine.

While practitioners may be able to prepare their own formulae of raw herbs, finished products will not be permitted. Thus, if you live in Britain or France and want to use Health Concerns’ Marrow Plus, for example—you will be “protected” from doing so by the EU government, unless they are able to obtain a license which doesn’t seem likely. (Currently, the EU Commission is also negotiating a “free trade” deal with India that may have the horrific impact of denying their capacity to make available antiretrovirals as generics with generic pricing; to our way of thinking, this is akin to a form of economic genocide). Whether this law will impact the United States is unknown, however you can be sure regulators will be watching keenly to see how it plays out in Europe.

Finally, one serious concern has been raised with regard to harmonization of laws, specifically regarding free trade agreements with central America (CAFTA). Some concern has been raised that passing CAFTA will result in a requirement to harmonize laws, which may represent a bigger threat than Codex if a Central American member nation has more stringent laws about dietary supplements that we have to match. Unfortunately, the major proponent of this view is Ron Paul, the libertarian representative from Texas. While in general we view the effects of free trade agreements as being deleterious most frequently to the poor and working classes both here and in affected Central American nations, it remains unclear how much of a risk CAFTA would pose to domestic law. The US Trade Representative disputes this flatly.

In all, the stew of laws and regulations bear close watching. We must advocate from our perspective of consumers and users of dietary supplements (and mainstream drugs!) We want to know what we use is safe and of good quality, whatever the source. The recent fine of $750 million levied against Glaxo SmithKline for knowingly distributing contaminated and falsely labeled drugs being a prime recent example.

And there’s more. We advocate for comprehensive, robust and ongoing evaluation of the identity, potency and purity of products by the FDA. For NIH, we advocate for funding for more clinical studies to evaluate dietary supplements. We want an even more robust, better funded National Center for Complementary and Alternative Medicine (NCCAM) to conduct clinical studies on the efficacy and limitations of micronutrients, botanicals, hormones like DHEA, fatty acids and other agents.

We further advocate for a more streamlined and appropriate process for FDA to review both structure/function and therapeutic claims. It took FDA nearly 40 years, despite mountains of data, to recommend folic acid supplementation for expectant mothers to prevent neural tube defects—it’s hardly as though there are not myriad other ways dietary supplements can help and improve our lives.

We know. We see it every single day.

April 30, 2010

THE SUPPLEMENT – NYBC’s newsletter -Spring 2010

Posted in cardiovascular health, diabetes, garlic, insulin resistance, THE SUPPLEMENT - Newsletter of NYBC, Vitamin D tagged , , , , at 10:45 am by jarebe

The latest issue of the New York Buyers’ Club newsletter is now available. This issue’s feature stories include:

Vitamin D: A Supplement for All Seasons? No longer just a cold & flu remedy!

Diabetes: Facts & Figures from the Epidemic With an information sheet on the key supplements that have been studied for diabetes/insulin resistance.

Blog on! Intriguing report on our blog readers’ most-used search terms.

The Power of Garlic Quite a career for the humble garlic bulb: from folk remedy, to Chinese medicinal herb, to a 2006 NIH/American Heart Association reseach study of its effect on cardiovascular function!

NEW @ NYBC A roundup of new botanicals and other supplements now available from NYBC–and why the co-op has chosen to carry them.

—-

You can read and/or download the latest issue of the NYBC newsletter THE SUPPLEMENT at:

http://www.newyorkbuyersclub.org/supplement/index.html

December 1, 2009

NEW! Managing and Preventing HIV Med Side-Effects

Posted in Acetylcarnitine, acidophilus, alpha lipoic acid, anxiety, B vitamins, bone health, calcium, cardiovascular health, Carnitine, cholesterol, Chromium, Coenzyme Q10, depression, DHEA, diabetes, diarrhea, digestive enzymes, fatigue, fish oil, Florastor, GABA, gastrointestinal health, Glutamine, hepatitis, HIV, immune support, insulin resistance, K-Pax alternative, lecithin, lipodystrophy, liver disease, mental health, milk thistle, Multivitamins, NAC (N-acetylcysteine), nausea, neuropathy, Niacin, Omega-3, pantethine, PharmaNAC, Probiotics, Saccharomyces boulardii, SAMe, sexual function, silymarin, sleep aids, sterols, THE SUPPLEMENT - Newsletter of NYBC, theanine, ThiolNAC, Traditional Chinese Medicine, triglycerides, Tryptophan, Vitamin B12, Vitamin C, Vitamin D tagged , , , , , , , , , at 12:18 pm by jarebe

To mark its fifth anniversary, the New York Buyers’ Club has prepared a special edition of SUPPLEMENT. In it you will find a concise Guide to managing and preventing HIV medication side effects with supplements and other complementary and alternative therapies.

This is an invaluable introduction to how nutritional supplements can be used to counter those side effects that can make life miserable–or even disrupt treatment adherence–in people taking antiretroviral medications for HIV.

Read about approaches to dealing with diarrhea, nausea, heart health issues, diabetes, insomnia, fatigue, liver stress, lipodystrophy, anxiety and depression.

This FREE Guide is available online at:

http://newyorkbuyersclub.org/

On the NYBC website you can also SUBSCRIBE to the nonprofit co-op’s quarterly FREE newsletter, THE SUPPLEMENT, which continues to offer a unique perspective on current evidence-based use of supplements for chronic conditions including cardiovascular disease, diabetes/insulin resistance, hepatitis and other liver conditions, anxiety/depression, osteoarthritis, cognitive and neurorological issues, and gastrointestinal dysfunction.

September 1, 2009

NYBC’s Quick Guide to Gastrointestinal Health

Posted in calcium, diarrhea, digestive enzymes, gastrointestinal health, Glutamine, HIV, Mastic Gum, nausea, Probiotics, Saccharomyces boulardii, THE SUPPLEMENT - Newsletter of NYBC, Traditional Chinese Medicine tagged , , , , , , , , , , , , , , at 3:27 pm by jarebe

A number of NYBC members and visitors to our website and blog have asked us to reprint the NYBC “Quick Guide to Gastrointestinal Health,” which first appeared in the Winter 2009 issue of our free newsletter THE SUPPLEMENT:

NYBC’s Quick Guide to Gastrointestinal Health

Gastrointestinal or gut health is basic to overall health, whether you’re talking about how well you feel on a daily basis (nausea, cramps, diarrhea, etc. being among our least favorite experiences), or the importance of properly absorbing food that you eat and thereby supplying your body with the nutrients it needs to stay healthy over the long term.

Gastrointestinal health can also be a complicated issue, since gut disturbances may stem from many different causes, whether it’s a bug picked up from poor food handling practices, a side effect of medications, or one of the symptoms of an underlying disease or infection (such as HIV) that requires treatment in itself. Identifying the root cause or causes of gastrointestinal problems can be a major challenge, and of course we urge you to work with your healthcare provider to sort that question out, especially if your condition lingers, becomes acute, or has an impact on your ability to go about your daily life.

Below we present various tips, tricks, news and research notes, all designed to help you maintain good gastrointestinal health, or find help when things are not going so well in your digestive tract.

Probiotics. These are “friendly” microorganisms that can re-balance the ecology of your gut. Probiotics are well-known for their benefit to digestive health, and especially for their ability to resolve some types of diarrhea. Here are the major types stocked by NYBC: bifidus (as Bifidus Balance/Jarrow); lactobacillus/bifidus (as Jarrodophilus/Jarrow—needs refrigeration); lactobacillus/bifidus (as Jarrodophilus EPS–needs no refrigeration); and Saccharomyces boulardii (as Florastor from Biocodex—needs no refrigeration).
Some NYBC members find that using Jarrodophilus every other day keeps diarrhea away. (And it’s actually cheaper than getting the probiotics from yogurt—though admittedly not quite so tasty or nutritious.) Another approach: try the green foods supplement Pro Greens (Nutricology), which has a rich variety of nutrients, but also includes a substantial lactobacillus/bifidus component. The BioCodex product Florastor, meanwhile, is most often used for antibiotic-associated diarrhea or to avoid “traveler’s diarrhea” (when started in advance of the trip).

Research note, as reported last year by John James in the online AIDS Treatment News Daily Alerts. The note deals with C. difficile, a diarrhea-producing infection that’s on the rise, and is often a lingering byproduct of antibiotic treatment: “A recent meta-analysis of 31 studies compiled and published in the American Journal of Gastroenterology concluded that S. boulardii is the only probiotic that is effective in fighting recurrent C. diff-associated disease. […] ‘Because Florastor (S. boulardii) is a yeast and not a bacteria, it is not killed by the strong antibiotics that are being used to kill the C. diff bacteria, so it survives in the digestive tract,’ says [researcher] Dr. Raymond. ‘When the ‘baby’ C. diff emerge from their spores, they are greeted by a well-colonized gut, rather than an empty playground.’”

Glutamine and other supplements to prevent diarrhea and maintain body weight. In the era of antiretroviral therapy, weight loss has become less of a problem for people with HIV. Yet maintaining muscle mass over time remains a big concern, and one key to that is controlling diarrhea, which deprives the body of needed protein and other essential nutrients.

One frequently used remedy for diarrhea is the amino acid glutamine. It has been studied for leaky gut syndrome, which results when intestinal tissues are damaged, and also has a long history of application to maldigestion in people with HIV. Anecdotally, people with protease-inhibitor diarrhea find relief using 30-40 grams per day. Start with about 15 grams per day and increase the dose until the diarrhea is controlled. A daily maintenance dose is about five grams a day. Note that glutamine is best taken in three daily doses.

Research note: A well-designed study published in the journal Nutrition found that a glutamine-antioxidant regimen was effective at helping HIV+ people with weight loss to regain body weight. The regimen included glutamine (40 g per day), along with vitamin C (800 mg), vitamin E (500 IU), beta-carotene (27,000 IU), selenium (280 mcg), and N-acetylcysteine (2,400 mg). People who took the supplements showed significant weight gain in 12 weeks, while participants taking a placebo did not.

Other supplements have also been used to counteract malabsorption and diarrhea associated with HIV and/or HIV medications:

Calcium: two Canadian studies from 2004 and 2005 re-affirm the thinking that calcium carbonate can be useful in controlling protease inhibitor-related diarrhea. Calcium supplements have long been used for this purpose by buyers’ club members; see the recommendations under “Digestive Maintenance” on the NYBC website for details.

Soluble fiber such as apple pectin, oat bran, and flax seed. For some people, soluble fiber can help food stay in the digestive tract for longer periods of time, increasing the amount of nutrients that are absorbed, and lessening bowel frequency.

Traditional botanicals/remedies for gastrointestinal health. NYBC stocks two formulas produced by the well-regarded California-based developers of herbals, Health Concerns and Pacific BioLogic. Both formulas are derived from traditional schools of herbal medicine (Chinese or Tibetan), but are also informed by modern clinical practice. Here are the indications for use supplied by the manufacturers:

Quiet Digestion (Health Concerns). Used to reduce gastric distress including pain, cramping, nausea, vomiting, diarrhea, regurgitation, poor appetite; addresses viral or bacterial gastroenteritis as well as motion sickness, hangover and jet lag effects.

GI Tract: Gastro Regulator (formerly Digest Ease) from Pacific BioLogic. Derived from a Tibetan medicine formula, it is designed to help the function of the gastrointestinal tract, helping to optimize the course of digestion and colonic function, particularly problems arising from bad dietary habits. There may be a brief period of diarrhea or constipation at the beginning of using this product.

Recently an NYBC member called our attention to Mastic Gum, a resin traditionally used in the Eastern Mediterranean as a remedy for heartburn, and generally to protect the stomach and duodenum. Now there’s intriguing new research supporting use of mastic for gastrointestinal health and perhaps additional purposes as well:

1. A study published in 2007 found evidence that mastic could help prevent or manage prostate cancer. This prostate-protective effect may be achieved via an inhibition of nF-KB–interestingly, that’s a cellular protein that HIV also hijacks to help produce more of itself.

2. Another recent study looked at use of 2.22 grams of mastic/day among patients with Crohn’s disease (a chronic, debilitating bowel disorder). Not only did this dosage help in this small pilot study, but two markers of inflammation were significantly reduced: interleukin-6 and C-reactive protein. Again, it’s of interest that both markers are also often elevated in HIV disease.

TheBody.com booklet: “The HIVer’s Guide to Coping with Diarrhea & Other Gut Side Effects.” NYBC recommends this thorough and easy-to-read booklet, which has been reviewed by HIV specialist physicians, and also includes case studies of people with HIV who have worked through some typical gastrointestinal problems. It can be read online, or ordered from thebody.com at http://www.thebody.com/content/art13137.html.
Here’s a capsule summary of the 29-page booklet:

Gastrointestinal or gut problems–diarrhea, nausea, indigestion, gas, loss of appetite–are very common for people with HIV, with consequences ranging from temporary to very serious. This booklet takes you through the common causes: HIV meds, other meds or supplements, the effects of HIV itself, your diet, psychological triggers, or other health problems (such as parasites). It then sorts through some of the most used remedies, including over-the-counter drugs, supplements, prescription meds, or changing your diet or your HIV drug regimen.

For further information, please also see individual product entries in the “Digestive Maintenance” section of the NYBC catalog. In addition to the items mentioned above in our “Quick Guide,” you’ll also find here our recommendations in the category of digestive enzymes:

DIGESTIVE MAINTENANCE

August 20, 2009

SUPPLEMENTS AND OTHER SMART STRATEGIES FOR LONGER LIVING – A panel discussion on traditional, complementary and alternative treatments for HIV

Posted in alpha lipoic acid, cardiovascular health, Carnitine, Coenzyme Q10, diarrhea, fatigue, HIV, insulin resistance, lipodystrophy, Nepal, neuropathy, THE SUPPLEMENT - Newsletter of NYBC, Traditional Chinese Medicine tagged , , , , at 10:54 am by jarebe

We reprint below our report on this June 2009 forum, which brought together a range of views on managing HIV:

SUPPLEMENTS AND OTHER SMART STRATEGIES FOR LONGER LIVING was the title of a panel discussion on traditional, complementary and alternative therapies for HIV presented on June 25, 2009 by the New York Buyers’ Club in celebration of its fifth anniversary. The event brought together experts whose knowledge spans East and West, and whose experience ranges from community organizing and scientific writing, to clinical research and the practice of medicine, whether as an M.D. or as a licensed acupuncturist and specialist in Chinese herbalism.

NYBC was especially proud to host our Guest of Honor, Sunil Pant, the first openly gay Member of Parliament in Nepal, and Founder/Director of the HIV-support organization the Blue Diamond Society, which was recognized by the International Gay and Lesbian Human Rights Commission in 2007 as “one of the most effective human rights groups in the world.” At the start of the panel discussion, our Guest of Honor gave a moving account of the work he and his organization have done over the last decade in securing rights for sexual minorities in Nepal, and in fighting for decent treatment of Nepalis with HIV/AIDS. Sunil also took a moment to recall the many years he has known and worked with our own George Carter, who has directed NYBC efforts to provide supplements and other aid to BDS.

We also felt privileged to hear from our other panelists: Dr. Paul Bellman, a NYC physician who has been treating people with HIV/AIDS since the start of the epidemic; Tim Horn, President and Editor of AIDSmeds.com; Alex Brameier, a licensed acupuncturist and herbalist; and George Carter, Director of the Foundation for Integrative AIDS Research. It’s true that the first two of these panelists are in the mainstream of AIDS treatment practice, by which we only mean to say that their main area of expertise is antiretroviral pharmaceuticals. Yet Dr. Bellman also spoke of the usefulness of several supplements that NYBC and its predecessor DAAIR have long recommended: alpha lipoic acid, carnitine, and CoQ10. Tim Horn, whose website focuses largely on pharmaceutical treatments, nevertheless also acknowledged that the “holistic” approach to long-term health for people with HIV makes a lot of sense. And he went on to say that he recognizes that a whole range of “therapies” (including even diet and exercise) may be needed to address worrisome trends in heart and lung disease among people with HIV who are taking ARVs.

Alex Brameier, the Lic. Ac. on our panel, engaged our audience with an impromptu survey on how people view their acupuncture treatments. She then discussed some of the conditions that lend themselves to acupuncture, based on clinical experience: pain relief, stress reduction, neurological and musculoskeletal disorders, to name a few. Very useful as well was the contrast she drew between acupuncture as practiced in China and Japan (where treatment may be daily or every other day), and the West, where time and financial constraints often dictate otherwise. Her tips on how to get the best out of acupuncture and how acupuncture and herbs can work together were also very valuable.

Last but not least among our contributors was George Carter, who’s had two decades of experience with supplements, from clinical research to acting as NYBC Treatment Director. George, as all who know him can attest, is nothing if not thorough, and for this event he prepared a “Short Primer on Side Effects,” a compact but comprehensive review of HIV medication side effects, ranging from malabsorption/diarrhea//nausea, to lipid abnormalities (of concern for cardiovascular health), to fatigue and insomnia, to insulin resistance/diabetes, to liver damage, to bone issues, to peripheral neuropathy. We hope to produce this super-useful handout as a handy pocket guide in the near future, so stay tuned.

An inspirational, lively, and (if we do say so ourselves) immensely informative event. If you were there, thanks for coming! And if not–we certainly hope to see you at the next one.

Reprinted from the SUMMER 2009 SUPPLEMENT: Newsletter of the New York Buyers’ Club, which can be read in its entirety at

http://newyorkbuyersclub.org/supplement/index.html

In addition to the piece above, this issue contains a report on how research on diet and nutrition has led to new knowledge about supplements (“Are You Ready to Join the Food Revolution?”), and a short review on HIV and cognitive impairment.

Note: Email subscriptions to THE SUPPLEMENT are free to NYBC members.

June 10, 2009

June 24: NYBC 5th Anniversary Birthday Party!

Posted in hepatitis, HIV, mental health, Nepal, THE SUPPLEMENT - Newsletter of NYBC, Traditional Chinese Medicine tagged , , , , , , , , , , , , , , , , , , , , at 10:13 am by jarebe

NYBC-5thAnniv-Poster.indd

New York Buyers’ Club Presents:

 “Supplements and Other Smart Strategies for Longer Living”

 A Free Panel Discussion with Experts on Both Eastern and Western Approaches to Treating HIV
––––––––––––––––––––––––––––––––––––––––––––––––––––––––
DATE: Wednesday June 24th, 7:00pm – 10:00pm
PLACE: The Center, 208 West 13th Street, New York City
MORE INFO: www.NewYorkBuyersClub.org/5

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

The New York Buyers’ Club (NYBC), a nonprofit nutritional supplements information exchange and purchasing co-op, celebrates its fifth anniversary with a free public forum entitled “Supplements and Other Smart Strategies for Longer Living.” Co-sponsored by Gay City News and POZ magazine, this event promises to be both informative and lively, with panelists including Sunil Pant, the first openly gay Member of Parliament in Nepal and an internationally recognized advocate for people with HIV/AIDS; Tim Horn, President and Editor-in-Chief of AIDSmeds.com; noted NYC physician Paul Bellman, who has specialized in caring for people with HIV since 1986; Ann (“Alex”) Brameier, a licensed acupuncturist and herbalist; and George Carter, Director of the Foundation for Integrative AIDS Research and Treatment Director of NYBC. The forum will be moderated by NYBC President Carola Burroughs, who has worked in the field of HIV education for two decades.

Since its inception in 2004, NYBC has been a source of information on alternative and complementary therapies, especially for people with HIV and/or hepatitis (see its comprehensive website at http://www.NewYorkBuyersClub.org). It has also functioned as a buyers’ co-op, making a unique catalog of supplements available to its US and international membership at very low cost. NYBC endorses a holistic approach to health and healing, embracing both traditional bodies of botanical knowledge and modern evidence-based research findings, and in general stressing the need to integrate diet/nutrition, mental health and physical health, appropriate supplementation and standard pharmaceuticals. Like its predecessor DAAIR (Direct Action Alternative Information Resources), NYBC also believes that everyone has the right to actively engage in researching and understanding their healthcare options, and that we all gain by learning to critically evaluate healthcare information provided by the media, the government, “Big Pharma,” or supplement manufacturers.

After statements from the participants and a moderated panel discussion, the floor will be open for a Q&A session, followed by champagne (or cider) and cupcakes in celebration of New York Buyers’ Club’s fifth anniversary.

Supplements and Other Smart Strategies for Longer Living
Wednesday June 24th, 7:00pm – 10:00pm
The Center, 208 West 13th Street, New York City
http://www.NewYorkBuyersClub.org/5

Meet the Panelists:

Guest of Honor Sunil Babu Pant is the first openly gay Member of the Constituent Assembly (Parliament) of Nepal, and the Founder and Director of the Blue Diamond Society (BDS), a community-based organization that has worked for the rights of sexual minorities and people with HIV since 2001. BDS played an active role in Nepal’s transition from a conservative (and homophobic) monarchy to a federal republic in 2006-7, and subsequently has been successful in several advocacy campaigns, including the effort to legalize gay marriage, making Nepal the first Asian country to do so. Now counting more than 150,000 members, BDS continues to provide care and support to Nepalis with HIV/AIDS, while also working to reduce stigma and discrimination against the Himalayan nation’s sexual minorities. In 2007, BDS received the Felipa de Souza award from the International Gay and Lesbian Human Rights Commission, which called it “one of the most effective human rights groups in the world.”

Paul Curtis Bellman, MD is a physician whose private practice in Greenwich Village, New York, has specialized in caring for HIV-positive patients since 1986. Dr. Bellman is a board certified internist and currently an associate attending in the Department of Medicine at St. Vincent’s Manhattan and a senior lecturer in the Department of Immunology at Weill Cornell Medical College in New York. He is a 1982 graduate of the New York University School of Medicine and has been involved in the clinical care of HIV-positive people since the epidemic began. Bellman actively participates in clinical research as well as the clinical practice of HIV medicine.

Ann Brameier, L. Ac. (known by all as Alex) is an herbalist and acupuncturist, licensed in New York since 1992. Certified by the National Certification Commission for Acupuncture and Oriental Medicine in both acupuncture and Chinese herbal medicine, she practices an individualized combination of acupuncture, acupressure, tuina and Chinese herbal medicine. Says Brameier: “Combining these modalities can address a myriad of health complaints to achieve a speedier resolution of the patient’s issues than might be achieved by application of only one of these ancient traditions.”

NYBC’s George M. Carter is the Director and Co-Founder of the Foundation for Integrative AIDS Research (FIAR), and has been an AIDS activist for nearly 20 years. His work has focused on research on the use of integrative, traditional, complementary, and alternative medicine therapies for HIV/AIDS and Hepatitis C, as well as the pathogenesis of HIV disease. Mr. Carter has attended numerous national and international conferences on HIV/AIDS, and has served as a civil society delegate for UNGASS sessions at the United Nations. Mr Carter serves as Treatment Director for New York Buyers’ Club.

Tim Horn is president and editor-in-chief of AIDSmeds.com. He has worked as a writer, editor and educator for a number of other AIDS organizations, including Physicians’ Research Network (PRN), the American Foundation for AIDS Research (amfAR), the AIDS Treatment Data Network, and the PWA Health Group. Tim is a member of the AIDS Treatment Activists Coalition and has also done an extensive amount of HIV education and advocacy-related work in Mexico, where he lived for 18 months, and was a founding board member of Aid for AIDS. He has been living with HIV since 1992.

September 13, 2008

Many Ways to Love Your Liver

Posted in alpha lipoic acid, Antioxidants, hepatitis, Hepatoplex, HIV, liver disease, SAMe, silymarin, THE SUPPLEMENT - Newsletter of NYBC, ThiolNAC, Vitamin C tagged , , , , , , , , , , , at 3:45 pm by jarebe

Many Ways to Love Your Liver

(reprinted from the NYBC SUPPLEMENT, Summer 2008)

Liver impairment is a frequent concern for people with HIV. There are many different causes, including co-infection with hepatitis, HIV meds that put added stress on the liver, excessive alcohol or recreational drug use, opportunistic infections, repeated resort to antibiotics, or just consuming big doses of the over-processed, nutrient-poor junk that too often passes for food these days! (By the way, we like the rule of thumb for choosing good stuff at the supermarket: if your grandmother wouldn’t recognize the item as “food”—then it’s probably not very good for you.)

The liver is crucial for processing and breaking down wastes, whether those produced by normal body functioning or those absorbed into the system in the form of drugs, alcohol, or toxins. So keeping it in good repair is essential for health. One specific strategy to support liver function is to maintain levels of the intracellular (= “found within cells”) antioxidant glutathione, which plays a key role in protecting the liver as it performs its detoxification duties. Here is a short list of nutritional supplements that are frequently recommended for this purpose: Vitamin C (2–6 grams per day, in divided doses); N-acetyl-cysteine, or NAC (500 mg, 3 times per day); alpha-lipoic acid (300-600 mg, twice daily). (Note that NAC and Lipoic can be taken in the combination form ThiolNAC, one of the key supplements stocked by NYBC.)

Another worthy option for countering stresses to the liver is an herb called Milk Thistle (Silybum marianum), which has a long tradition of use as a botanical remedy. Modern research has isolated compounds referred to as silymarin within this plant, and many studies have pointed to silymarin’s effectiveness in protecting liver cells from toxic chemicals, and even in stimulating the repair and regeneration of liver cells. In 2007, a federally funded investigation identified one component of milk thistle as a potent anti-cancer agent, and suggested that it held much promise in protecting against or treating liver cancer. Be advised that if you consult sources such as the Canadian AIDS Treatment Information Exchange (CATIE) website, you may encounter concerns about whether silymarin interferes with HIV meds. But here’s what one National Institutes of Health study concluded: “Milk thistle in commonly administered dosages should not interfere with indinavir therapy in patients infected with the human immunodeficiency virus.” This and other research, we believe, suggests that milk thistle-HIV med interference is not actually a very signficant issue.

Now here’s a rather unusual dietary supplement that has been investigated for liver health: S-adenosylmethionine (SAM-e). First isolated by Italian researchers in the 1950s, SAMe is synthesized by living cells from the amino acid methionine and can’t be supplemented from food sources. In several European studies of people living with hepatitis B or C, it has been shown to help reduce jaundice, fatigue, and other symptoms. And it’s also been applied to treating alcohol-related damage to the liver. The unusual aspect of SAMe is that there’s also a great deal of published research on its value as an antidepressant and as a treatment for arthritis—so it’s quite a versatile molecule! (See the NYBC Blog at http://www.nybc.wordpress.com for more details.)

Last, we note that the New York Buyers’ Club, like its predecessor DAAIR, has carefully followed the modern, US-based study and dissemination of traditional Chinese herbal remedies for liver disease. For example, NYBC stocks Pacific Biologic’s Hepato-C and Hepato-Detox, and, more recently, has added Health Concern’s Hepatoplex One and Hepatoplex Two to its product list. Both of these California-based companies have a very good reputation for quality, and both have devised blends based on Traditional Chinese Medicine as well as current clinical experience by licensed practitioners. (Please consult the NYBC website for more information about the specific herbs in these formulas, as well as recommendations for their use.) Of course we’re always interested in hearing about the experience of our members in using these products, and so we welcome your comments and questions—just email us at contact@newyorkbuyersclub.org.

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