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ABSTRACT: Some vitamin and dietary supplements are sporting a new certification seal from the U.S. Food and Drug Administration (FDA) designated representative in hopes of assuring consumers that the product lives up to its ingredient labeling claims.

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COMMENTARY: The United States Pharmacopeia (USP), an independent agency that serves as the government's official compendium for dietary supplement standards, has begun to issue the certification on hundreds of products that it has independently tested as part of its Dietary Supplement Verification Program (DSVP).

This new program is voluntary and open to all manufacturers of dietary supplements operating in the U.S., a $17-billion-a-year market that includes vitamins, minerals, herbs, botanicals, and sports supplements sold over the counter and consumed by two of every three Americans.

To receive the certification, manufacturers must submit products they select to a "vigorous" seven-step testing and evaluation process that the USP says it ensures meets all labeling claims — first in independent laboratories and then on store shelves. This process includes testing and auditing of declared ingredients, their amounts or dosages, and meeting requirements of limits on contaminants.

So far, hundreds of supplements by two leading manufacturers have been tested and issued the certification. Products that will receive the certification label include those by Nature Made, which just began to hit shelves at some 30,000 stores nationwide, and those under the Kirkland brand, which will be displayed at Costo stores beginning next week.

Together, Nature Made and Kirkland produce about 30% of all vitamins and minerals consumed nationally, and about 20% of the total supplement market, said Richard Wailes, USP's head of sales and marketing. Four other manufacturers have signed up for the certification program and their products will carry the "Dietary Supplement Verified" certification in 2003.

Under the program, manufacturers can submit any products they choose and pay for all testing by USP, which has been establishing drug and other product standards since 1820 and has worked hand-in-hand with the FDA since the federal agency was created in 1938.

Because the FDA regulates dietary supplements as foods and not "conventional" medicines, manufacturers typically do not have to get FDA approval before producing or selling dietary supplements. The FDA can take action only if a product is deemed unsafe and is already on the market.

STUDY: Muscle strength and the degree of abdominal obesity were directly related to BMD

JOURNAL: J Int Med 2002;252:000-000.

AUTHORS: Dr. Kerry J. Stewart

ABSTRACT: Although mild exercise has been shown to reduce the risk of heart disease, it does not appear to be osteoprotective, according to findings from a recent study.

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COMMENTARY: Mild physical activity does not seem to be "sufficient to hold off or attenuate the age-related decline in bone with aging," said lead author Dr. Kerry J. Stewart, from Johns Hopkins University in Baltimore.

While mild activity and aerobic fitness did not affect bone mineral density (BMD), muscle strength and the degree of abdominal obesity were directly related to BMD, according to the report published in the Journal of Internal Medicine.



Although being fat may be good for bone density, gaining weight is not the answer because of the harmful effects of obesity on many other aspects of health.

Dr. Stewart's team studied the effects of mild physical activity in 38 men and 46 women, 55 to 75 years of age, with high normal blood pressure or mild hypertension. None of the participants exercised on a regular basis.

Neither overall aerobic fitness nor participation in mild physical activity had a significant effect on BMD, the researchers note. But muscle strength, as well as abdominal obesity, was associated with denser bones.

They found that being more fat and having stronger muscle, which is common in fatter people, along with hormone replacement therapy, had the most influence on bone. In particular, having more abdominal fat was most strongly linked to bone density.

Exactly how abdominal obesity may promote increases in BMD is unclear, but Dr. Stewart suggested that the hormone leptin may be involved. Leptin levels tend to be higher in obese people, he explained, and findings from animal studies indicate that leptin increases the activity of bone cells.

STUDY: TSH level between 3.0 and 5.0 uU/ml ...should be considered suspect.

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ABSTRACT: Major Reversal at American Association of Clinical Endocrinologists Regarding TSH Levels and Diagnosing Hypothyroidism

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COMMENTARY: In what constitutes a fairly dramatic reversal of its previous doctrine regarding how hypothyroidism should be diagnosed, the American Association of Clinical Endocrinologists (AACE) has said that:

"Even though a TSH level between 3.0 and 5.0 uU/ml is in the normal range, it should be considered suspect since it may signal a case of evolving thyroid underactivity."



This is the first time a conventional U.S. medical organization has acknowledged that the upper half of the TSH test's normal range may not in fact be normal, but rather, evidence of developing hypothyroidism, or a level that is potentially able to cause hypothyroidism symptoms in patients.

The conventional endocrinology doctrine has, for several decades, dictated that a TSH level that is in the so-called "normal range" indicate a "euthyroid" -- or normal -- state for the thyroid, and thus does not warrant treatment, despite clinical symptoms.

In fact, most patients who have numerous clinical symptoms of hypothyroidism, as well as a family history of thyroid disease -- and even those who have tested positive for the presence of thyroid antibodies indicative of autoimmune Hashimoto's Disease -- are declined treatment by endocrinologists and other physicians unless TSH levels are elevated above the laboratory's "normal range" -- which is typically a TSH level anywhere from 4.7 to 6.0 uU/ml.

Many people who are suffering thyroid symptoms. . . may now be considered hypothyroid and eligible to be diagnosed and treated.

The AACE's acknolwedgement lags years behind the efforts of a number of pioneering physicians and patient advocates -- as well as what patients themselves have suspected.

Almost four years ago, for example, Dr. A P Weetman, a professor of medicine, wrote in the article "Fortnightly review: Hypothyroidism: screening and subclinical disease" which appeared in the 19 April 1997 issue of the British Medical Journal, the following groundbreaking statement:

". . . even within the reference range of around 0.5-4.5 mU/l, a high thyroid stimulating hormone concentration (>2 mU/l) was associated with an increased risk of future hypothyroidism. The simplest explanation is that thyroid disease is so common that many people predisposed to thyroid failure are included in a laboratory's reference population, which raises the question whether thyroxine replacement is adequate in patients with thyroid stimulating hormone levels above 2 mU/l."

"Why are we following a test which has no correlation with clinical presentation? The thyroidologists by consensus have decided that this test is the most useful for following treatment when in fact it is unrelated to how the patient feels. The consequences of this have been horrendous. Six years after their consensus decision Chronic fatigue and Fibromyalgia appeared. These are both hypothyroid conditions. But because their TSH was normal they have not been treated. The TSH needs to be scrapped and medical students taught again how to clinically recognize low thyroid conditions."

Other physicians have been working with antibodies testing to evaluate thyroid function, and in some cases treating patients with normal range TSH values who had thyroid antibodies evident of the autoimmune disease process.

Elizabeth Vliet, MD, who runs the popular women's health centers, Her Place and who is author of the bestselling book, Screaming to be Heard: Hormonal Connections Women Suspect...and Doctors Ignore, has never believed that TSH tests are the indicator of a woman's thyroid health. Since the mid 1990s, Dr. Vliet has been saying that symptoms, along with elevated thyroid antibodies and normal TSH, may be a reason for treatment with thyroid hormone. Here's a quote from her book:

"The problem I have found is that too often women are told their thyroid is normal without having the complete thyroid tests done. Of course, what most people, and many physicians, don't realize is that...a 'normal range' on a laboratory report is just that: a range. A given person may require higher or lower levels to feel well and to function optimally. I think we must look at the lab results along with the clinical picture described by the patient...I have a series of more than a hundred patients, all but two are women, who had a normal TSH and turned out to have significantly elevated thyroid antibodies that meant they needed thyroid medication in order to feel normal. This type of oversight is particularly common with a type of thyroid disease called thyroiditis, which is about 25 times more common in females than males...a woman may experience the symptoms of disease months to years before TSH goes up..."

The current TSH levels used by laboratories to define the "normal" range of thyroid function, and the use of the TSH test as primary means of diagnosis need to be significantly reevaluated. The .5 to 5.5 "normal range" for thyroid function is just not enough information for diagnosis anymore.

Research reported in the British Medical Journal found that TSH levels above 2 are likely not normal, and instead include people at high risk to develop thyroid disease. This means that the real "normal range" is probably far narrower, and more concentrated in the lower end of the range.

New studies need to be conducted to look at this issue comprehensively, evaluating the true normal range for a population of individuals who have no thyroid antibodies, and who do not ever go on to develop thyroid disease in their lifetimes.

In February of 2000, a groundbreaking study estimated that as many as 13 million Americans had undiagnosed thyroid disease. The vast majority of these people would be women, suffering from undiagnosed hypothyroidism. This Colorado Thyroid Disease Prevalence Study used the standard diagnostic criteria to define hypothyroidism -- that the TSH had to exceed the lab's normal range, which for the purposes of this study, was 5.1 uU/ml. Broadening the lab diagnostic criteria then, to levels above 3 would mean that the Colorado Thyroid Disease Prevalence Study suggests that many more than 13 million Americans are likely to be defined as hypothyroid.

STUDY: Frequent jolts, vibration may cause abnormalities in scrotum.

JOURNAL: Annual meeting of the Radiological Society of North America.

AUTHORS: Dr. Ferdinand Frauscher

ABSTRACT: Frequent mountain-biking may reduce fertility in men, according to a small Austrian study that adds fodder to a debate over cycling and male sexual function.

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COMMENTARY: The research suggests frequent jolts and vibration caused by biking over rough terrain may cause abnormalities, including small scars within the scrotum and impaired sperm production.



The abnormalities were found in professional mountain bikers and other “extreme” bikers who logged at least 3,000 miles yearly — or an average of more than two hours a day, six days a week.

Dr. Ferdinand Frauscher, a urology-radiology specialist at University Hospital in Innsbruck, Austria, said he studied about 55 avid mountain bikers and found nearly 90 percent had low sperm counts and scrotal abnormalities.

Only 26 percent of the 35 non-bikers he studied had similar damage, according to research presented at this week’s annual meeting of the Radiological Society of North America.

Whether the abnormalities were severe enough to make fathering a child difficult is uncertain, though some of the bikers studied had already experienced difficulty conceiving.

Participants were aged 17 to 44. His study looked at fertility rather than impotence, which was linked to recreational cycling in research heavily publicized in 1997. The earlier findings, by Boston University impotence specialist Dr. Irwin Goldstein, were construed by many cycling aficionados to suggest that men should avoid any cycling sports.

Some doctors thought Goldstein’s findings were overstated, but the issue has prompted a mini-industry of bicycle seats designed to avoid the compression of penile arteries that Goldstein said occurs during cycling.

Such problems may occur on narrow, racing-type seats, Frauscher said. Some newer, wider designs feature holes or gaps to avoid pressure, but these likely would have no effect on the scrotal damage found in the Austrian study, which may be caused by jolting over rough terrain rather than artery compression, Frauscher said.

Frauscher said men shouldn’t avoid mountain biking because of the study, but should perhaps consider investing in bikes with shock absorbers or suspension systems designed to reduce the jolting.



Stanford University urologist Dr. Robert Kessler said he was skeptical of Frauscher’s findings. Scrotal varicose veins, which were among the abnormalities Frauscher linked to mountain biking, are usually congenital and not linked to trauma, Kessler said.

Dr. Eduardo Randrup, a urologist at Ochsner Clinic in New Orleans, said the link is plausible but not necessarily cause for alarm. The damage Frauscher found “may well be reversible” and likely would not occur from recreational cycling, Randrup said.

Dr. Sangili Chandran, a sports medicine specialist at Christ Hospital and Medical Center in the Chicago suburb of Oak Lawn, said other studies have found similar results but, like Frauscher’s, have been too small to be conclusive.

Even if the results are corroborated in future studies, very few mountain biking enthusiasts are logging enough miles to worry about any fertility impairment.

STUDY: Production of cytokines to blame

JOURNAL: Am J Respir Crit Care Med 2002;166:1055-1061

AUTHORS: Dr. E. Rand Sutherland

ABSTRACT: The production of cytokines after melatonin stimulation by mononuclear cells from patients with asthma suggests that melatonin may exacerbate their symptoms, according to a report in the American Journal of Respiratory and Critical Care Medicine.

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COMMENTARY: Patients with nocturnal asthma show circadian variations in airflow limitation, the authors explain, and melatonin is a key regulator of circadian rhythms as well as an important immunomodulatory in allergic diseases.

Dr. E. Rand Sutherland and colleagues from National Jewish Medical and Research Center and the University of Colorado Health Sciences Center in Denver, Colorado evaluated the effect of melatonin stimulation on peripheral blood mononuclear cell (PBMC) cytokine production at 4 a.m. and 4 p.m. in 5 normal control subjects, 6 patients with nocturnal asthma, and 12 patients with non-nocturnal asthma.

Melatonin stimulation significantly increased the production of IL-1, IL-6, and TNF-alpha by zymosan-stimulated PBMCs in all subject groups at both stimulation times, the authors report.

Nocturnal asthma patients had higher IL-1 production levels than normal subjects did, the report indicates, though (for both groups) 4 a.m. and 4 p.m. levels did not differ. Patients with non-nocturnal asthma had IL-1 production levels similar to controls subjects at 4 a.m., but these levels increased nearly 5-fold at 4 p.m.

Melatonin-stimulated IL-6 production patterns were very similar to those seen with IL-1 production, the results indicate.

In contrast, both nocturnal asthma patients and non-nocturnal asthma patients showed substantially higher melatonin-stimulated TNF-alpha production at 4 p.m. than at 4 a.m., the researchers note, whereas control subjects showed similar increases at both times.

These results suggest differential immunomodulatory effects of melatonin based on asthma clinical phenotype and may indicate an adverse effect of exogenous melatonin in asthma. For these patients, avoidance of melatonin may be appropriate until further information about the clinical effect of melatonin in asthma becomes available.