|LE Magazine November 2000 |
Can You Trust The Government's Database?
When searching for medical information, a popular place people check out is a database called MEDLINE, which is maintained by the National Library of Medicine. This free service provides instant access to abstracts published in more than 4,000 scientific journals. While MEDLINE can provide valuable information, it is by no means the final word as it relates to scientific validation. There are other medical databases, sometimes emanating out of Europe, which contain published studies that MEDLINE often omits.
If you are seeking an important piece of medical information, you may miss it if you rely strictly on MEDLINE. The problem of omitted studies on MEDLINE was the subject of an article that appeared in The Journal of the American Osteopathic Association.(1) The doctors writing this article used MEDLINE to find 19 clinical trials supporting the use of saw palmetto extract in the treatment of benign prostate enlargement. These 19 studies alone were quite impressive, but this article showed that there were 39 published studies about saw palmetto on other databases that were not found on MEDLINE. The doctors pointed out that MEDLINE only listed 33% of the total published studies on the clinical use of saw palmetto in the treatment of benign prostate enlargement.
What does this mean to the person seeking novel methods for preventing or treating disease? First of all, when you hear some “expert” being interviewed by the media on a medical topic, you should know that the expert is usually relying on MEDLINE as their source. In 1994, a major television network was trying to attack The Life Extension Foundation for promoting saw palmetto extract. The network had found a Harvard professor who said there was no evidence that saw palmetto was effective. We conducted a worldwide database search in 1994 and found 28 published studies substantiating the benefits of saw palmetto. Upon presenting this scientific evidence to the TV network, the issue was immediately dropped. If we had to rely on MEDLINE back in 1994, the evidence would have been skimpy. By using European databases, we documented saw palmetto’s efficacy and prevented the media from destroying the credibility of this important herbal supplement.
Protecting the First Amendment
Dr. Julian Whitaker, Durk Pearson and Sandy Shaw and others have sued the FDA to force the agency to allow a health claim that saw palmetto extract is effective in helping to alleviate urinary symptoms associated with benign prostate disease.
The FDA’s position is that saw palmetto cannot be sold as a dietary supplement if a claim is made that it has been shown to ameliorate symptoms related to prostate disease. The FDA is not saying that saw palmetto is ineffective or dangerous. Instead, the FDA’s contention is that saw palmetto has to go through the tortuous new drug approval process if health claims are to be made for it. This flies in the face of the meaning of laws passed in Congress in 1991 (NLEA) and 1994 (DSHEA ) that specifically permit these types of health claims on dietary supplements.
If the FDA has its way in Federal Court, no one will be able to inform Americans about the published studies supporting the efficacy of saw palmetto extract and many other natural supplements that cannot be patented. If a supplement cannot be patented, no one is going to spend the money taking it through the FDA’s drug approval quagmire. This means that under the FDA’s current legal theory, Americans are to be denied access to information about natural approaches to alleviating disease symptoms and instead should rely exclusively on expensive, side-effect prone, FDA-approved drugs.
We view the FDA’s position as blatantly unconstitutional, since the agency’s basis for denying consumer access to saw palmetto extract is based solely on the fact that a certain health claim is being made. Consumers fought long and hard to convince Congress to deny the FDA the ability to embargo sales of dietary supplements based solely on health claims. The FDA is now seeking to circumvent the will of Congress and the people by stating that the First Amendment does not apply to certain types of health claims (even if the claims are true) on dietary supplements. Up until now, the Federal Appeal’s Courts have ruled against the FDA on this issue.
We view the FDA’s latest attempt at censorship to be particularly egregious considering that millions of American men are already using saw palmetto extract to alleviate urinary discomfort. We hope the Federal Courts will continue to rule in favor of the First Amendment as it relates to health claims, instead of allowing the FDA to censor truthful information at the behest of drug companies who seek to deny Americans access to low cost herbal remedies.
Meanwhile, back in the real world of science, a new study published in the Journal of Urology showed that saw palmetto extract caused a specific contraction of epithelial prostate gland tissue. This new finding may indicate a mechanism to explain the clinical efficacy of saw palmetto.(2) This placebo-controlled study, conducted at the UCLA School of Medicine, adds to the growing body of evidence supporting the safety and efficacy of standardized saw palmetto extracts. In a recent German study, Dr. H. Schilcher makes an interesting comparison between drug and herbal based prostate therapies in the following statement:(3)
“All and all, far more experimental and clinical studies have been conducted with herbal prostate drugs than with ‘fashionable’ drugs, such as alpha 1-receptor antagonists and finasteride (Proscar) . . . .”
As most Foundation members know, saw palmetto extract was approved as a drug in Europe to alleviate urinary miseries in the early 1980’s. Yet, here we are in the year 2000 battling the FDA in the Federal Courts just to be able to convey the results of published studies to the American consumer.
Government may be underestimating life expectancy
According to a study published in the prestigious journal Nature, life expectancy in the U.S. and other industrialized nations will continue to rise, with no slowdown in sight. The researchers who conducted the study forecast that the average life span is well past age 80 in seven nations, which exceeds government predictions.(4)
In Japan, life expectancy may be an astounding eight years longer than currently predicted—about age 91, rather than 83. The Japanese are already the world’s longest-lived people, and some studies suggest that the isoflavone and polyphenol-rich Japanese diet plays a role in their remarkable longevity. In the U.S., the average life span of adults may be closer to 83 rather than to the government’s estimate of about 80 years.
The investigators in the Nature study found that in each country, death rates for all age groups dropped exponentially at a constant rate. With the amazing series of discoveries in medicine in the last century, the researchers report, there is no compelling reason that the future will be different. The investigators attribute the increased life expectancy to progress against heart disease, stroke and other aging-related killers. These investigators predicted that further medical advances should allow even better control of age-related diseases in the future, making it possible to sustain the rapid pace of mortality decline.
We at Life Extension believe that these revised numbers carry significant implications for the future of government programs for the elderly. This means the Federal government should be looking at more aggressive ways of keeping people healthy as they age to prevent a healthcare economic meltdown.
One way of accomplishing this is to recommend that older people protect their immune function by consuming low cost supplements such as zinc and selenium. A new study shows that certain nutrients influence the number and function of natural killer cells—immune cells that defend the body against some tumors and infections.(5) Advanced age is associated with impaired function of natural killer cells and this immune dysfunction makes the elderly particularly vulnerable to influenza, pneumonia and certain cancers.
To explore the connection between nutrition and natural killer cells, the researchers studied northern Italian men and women who lived independently and who ranged in age from 90 to 106 years. All were in good health and were apparently well nourished. The investigators found that many of these individuals had deficiencies of certain nutrients. Selenium deficiency was found in about 50% of both men and women. For zinc, 52% of the men and 41% of the women were deficient. Deficiencies were also noted in vitamins A, E, B6 and folate, as well as in coenzyme Q10. The percentage of natural killer cells was higher when blood levels of zinc were higher in the men and women studied, and when the level of selenium was higher in women. In women only, the activity of the natural killer cells was greater when blood levels of vitamin E and CoQ10 were higher.
This latest report on the effects of nutrition on immune function confirms a previous study showing that seniors taking modest doses of a multi-nutrient supplement containing zinc and selenium showed a general reduction in infection and required antibiotics for significantly fewer days.(6) Another well-designed study found that seniors taking zinc and selenium cut the number of infections by nearly two thirds compared to placebo.(7) A follow-up study demonstrates that elderly people supplementing with zinc and selenium show improved antibody response to the flu vaccine.(8)
While politicians are seeking tax-payer subsidies to help the elderly pay for prescription drugs, the fact is that the health care system is being bankrupted by aging people contracting expensive illnesses that are largely preventable with the use of affordable supplements. Instead of advocating that people protect themselves against nutrient deficiency, the FDA continues to campaign against low-cost, natural methods of preventing disease.
This issue of Life Extension provides an update on the best documented nutrients to reduce one’s risk of developing degenerative disease. The scientific evidence to support these new findings comes exclusively from published studies obtained from the worldwide medical databases, in addition to MEDLINE. We at The Life Extension Foundation learned long ago that the government’s MEDLINE database provided only a limited amount of the information needed to develop a comprehensive program to keep members in an optimal state of health.
Only a handful of people are paying the legal costs of battling the FDA's attempt to deny the public access to truthful, non-misleading scientific information. The First Amendment victories over the FDA to date have been remarkable, but the FDA continues to squander tax dollars in an effort to protect the drug companies against low-cost dietary supplements. You can help support litigation being spearheaded by Durk Pearson, Sandy Shaw, Julian Whitaker and others by sending a donation to:
Pearson and Shaw Litigation Fund
Emord and Associates
5282 Lyngate Court
Burke, VA 22015
All of the legal briefs filed for Durk and Sandy by Jonathan Emord and Associates can be found at www.emord.com.
1. J Am Osteopath Assoc 2000 Feb;100(2):89-96.
2. J Urol 2000 May;163(5):1451-6.
3. Wien Med Wochenschr 1999;149(8-10):236-40.
4. Nature 2000;405:789-792.
5. American Journal Clinical Nutrition 2000;71:590-598.
6. Lancet 1992 Nov 7;340(8828):1124-7.
7. Ann Nutr Metab 1997;41(2):98-107.
8. Archives of Internal Medicine 12 Apr 1999, 159/7 (748-754).