~ Dietary Supplements Attacked by the Media, Part 2

Biased attack on glucosamine

The next victim of the media’s witch hunt was glucosamine, which was one of several agents tested as a treatment for osteoarthritis of the knee.

The media’s deceptive stories were based on a study of people with mild to severe knee pain who were given a form of glucosamine not normally found in dietary supplements. Some participants received this form of glucosamine by itself, while others were given chondroitin sulfate by itself, a combination of glucosamine and chondroitin, or the drug Celebrex®.

The results of this study were encouraging, but the media distorted the findings in a way that made it appear that glucosamine-chondroitin supplements were of little value. A number of media outlets proclaimed that arthritis sufferers were wasting their money by taking glucosamine. While this made compelling headlines, it did not accurately convey what was written in the actual study.

The findings from the actual scientific study made it clear that glucosamine and chondroitin taken together were effective in those with moderate to severe arthritis of the knees. 59

Media may not have read glucosamine study

The media appears to have relied on a biased editorial that accompanied the actual scientific report on glucosamine. For instance, the New York Times said the following about this arthritis study:

“No effect was found for glucosamine, chondroitin, or the combination of both.” 60

Yet on page 804 of the study (which was published in New England Journal of Medicine, the following was stated about patients with moderate to severe arthritis of the knee who took glucosamine-chondroitin therapy:

“…combined treatment was significantly more effective than placebo” 59

The actual study went on to say that in those with moderate to severe arthritis, the combination of glucosamine-chondroitin resulted in a 24.9% to 26.4% improvement in pain relief. This result exceeded the 20% response to treatment measurement that the scientists themselves stated would prove efficacy. 59

As far as reversing the structural damage inflicted to the knee by osteoarthritis, the scientists stated:

“Treatment with chondroitin sulfate was associated with a significant decrease in the incidence of joint swelling, effusion, or both.” 59

In their concluding remarks, the scientists stated:

“Our finding that the combination of glucosamine and chondroitin sulfate may have some efficacy in patients with moderate-to-severe pain is interesting, but must be confirmed by another trial.” 59

As anyone who understands the English language can read, even this different form of glucosamine, when combined with chondroitin sulfate, demonstrated efficacy in patients most in need, i.e., those with moderate-to-severe pain! The media overlooked these clearly written findings in their haste to viciously attack glucosamine and chondroitin dietary supplements.

Better than Celebrex®

One of the arms in this arthritis study was given 200 mg a day of Celebrex®, an FDA-approved arthritis drug.

In patients with moderate to severe knee pain, however, the only treatment that showed significant benefit was glucosamine-chondroitin.

The media, however, chose to tout the mediocre benefits that Celebrex® showed in this study. For instance, in a widely distributed Associated Press story, the following was stated about Celebrex®:

“The drug Celebrex did reduce pain -- 70 percent reported improvement -- affirming the study's validity.” 61

The inclusion of Celebrex, in fact, did not affirm the study’s validity considering that 60 percent of the placebo group also reported improvement. The authors of this study stated that compared to placebo, Celebrex® was “ not significantly better.” 59

In the concluding remarks, these scientists stated:

“However, even the effects of celecoxib (Celebrex®) were smaller than those seen in other studies.” 59

The media exaggerated the benefits of Celebrex while vilifying glucosamine-chondroitin, carrying on a long tradition of bias against dietary supplements.

The arthritis study’s disappointing findings

The data that caused these negative media stories involved study subjects with mild knee pain. The scientists noted that in these patients, “differences between placebo and the various agents were relatively small.” 59

As compared to placebo, here were the pain score percentage point improvements for overall groups within this study: 59

Therapy

Improvement in Primary Pain Score

Improvement in Secondary Pain Score

Glucosamine HCL only (note this is not glucosamine sulfate)

3.9%

3.7%

Chondroitin sulfate only

5.3%

6.6%

Glucosamine HCL + chondroitin sulfate

6.5%

8.5%

Celebrex®

10%

10.4%

The scientists who conducted this study appropriately noted that only three of the above changes were significant overall. Furthermore, for the primary outcome in the combined glucosamine + chondroitin group, the results were very close to reaching statistical significance. For the secondary outcome, it did reach significance!

The media misinterpreted these findings and used them as ammunition to attack the efficacy of glucosamine and chondroitin supplements.

Conflicts of Interest

The New England Journal of Medicine recently enacted a policy of mandating disclosure of potential financial conflicts of interest amongst the authors of the studies it publishes. The reason for this was past instances of questionable articles supporting the safety-efficacy of drugs authored by doctors who were financially beholden to pharmaceutical companies that made the drugs.

What follows are the potential conflicts of the authors of the negative glucosamine study as reported by the New England Journal of Medicine:

“Drs. Bingham, Brandt, Clegg, Hooper, and Schnitzer report having received consulting fees or having served on advisory boards for McNeil Consumer and Specialty Pharmaceuticals. Drs. Brandt, Moskowitz, Schnitzer, and Schumacher report having received consulting fees or having served on advisory boards for Pfizer. Dr. Brandt reports having equity interests in Pfizer. Drs. Moskowitz and Weisman report having received lecture fees from Pfizer; Dr. Brandt, lecture fees from McNeil Consumer and Specialty Pharmaceuticals; Drs. Bingham, Clegg, Hooper, Jackson, Molitor, Sawitzke, and Schnitzer, grant support from Pfizer; and Dr. Bingham, grant support from McNeil Consumer and Specialty Pharmaceuticals. Dr. Brandt reports having received royalties from books related to osteoarthritis. Dr. Moskowitz reports having served as an expert consultant for Pfizer.” – pp. 807 “Dr. Hochberg reports having received consulting fees from Pfizer and Merck and speaker’s fees from Merck and Institut Biochimique.” 59

Arthritis drugs are (or have been) huge moneymakers for the pharmaceutical companies. These same companies have paid monies to doctors who designed, oversaw, and authored the New England Journal of Medicine study and the negative editorial about glucosamine. Readers can make their own determination if this represents frank bias or, at a minimum, a disingenuous approach to scientific research.

The encouraging findings from the arthritis trial

As noted earlier, significant benefits were seen in patients with moderate to severe arthritis of the knee in the glucosamine-chondroitin group. Compared to placebo, the pain score percentage point improvements in the moderate to severe arthritis group were as follows: 59

Therapy

Improvement in Primary Pain Score

Improvement in Secondary Pain Score

Glucosamine HCL only (note this is not glucosamine sulfate)

11.9%

17.1%

Chondroitin sulfate only

7.1%

10%

Celebrex®

15.1%

18.1%

Glucosamine HCL + chondroitin sulfate

24.9%

26.4%

In patients with moderate to severe knee pain, Celebrex® provided modest relief, whereas glucosamine-chondroitin showed significant reductions in pain scores. It is interesting that Celebrex® was not criticized by the media, even though it failed to produce the expected results in this sub-group of patients suffering with moderate to severe pain.

Wrong form of glucosamine used

A troubling flaw in this study is that the wrong form of glucosamine was given to the study subjects. Glucosamine sulfate is the most prevalent form of glucosamine used in dietary supplements. Most of the studies showing significant efficacy used glucosamine sulfate, but the form used in the New England Journal of Medicine study was glucosamine hydrochloride.

Since the study subjects received glucosamine hydrochloride, they were not obtaining the joint-protecting benefits conferred by the sulfur found in the “sulfate” part of the glucosamine compound. The anti-arthritis benefits of sulfur are so well documented that many arthritis patients find relief with a low-cost supplement called MSM (methylsulfonylmethane), which is a concentrated source of sulfur. 62-72 The anti-arthritic properties of SAMe (s-adenosyl-methionine) are also thought to be related to its high sulfur content. 73-79

In this New England Journal of Medicine study that made headline news around the world, the subjects taking glucosamine only were getting no supplemental sulfur. Even the group getting the glucosamine and chondroitin was only getting a small amount of sulfur (from the chondroitin sulfate only).

Why the media attacked glucosamine

In an editorial appearing in the same issue of the New England Journal of Medicine, glucosamine was harshly criticized. It was obviously a lot easier for the media to echo one doctor’s condemnation than to take the time to read the actual study itself.

This one doctor, by the way, receives consulting fees from Pfizer and Merck. In fact, a number of the authors of the glucosamine study published in the New England Journal of Medicine receive compensation from big pharma, mostly from Pfizer, which is the maker of Celebrex®. None of the study’s authors had an economic interest in glucosamine or chondroitin. Some in alternative medicine have said this is equivalent to having an opposing team’s referees dictate the outcome of a sporting event.

What most people don’t realize, however, is that it is not the obligation of the media to provide accurate reporting. The media is responsible for generating profits for its shareholders, which means they have to grab the public’s attention with sensational headlines that sell newspapers, TV viewing time, etc.

Reporting on the positive parts of the New England Journal of Medicine study would not have motivated many people to buy a newspaper. After all, there are dozens of studies substantiating the anti-arthritic properties of glucosamine sulfate and chondroitin sulfate. 59, 80-110 One more new study is hardly a newsworthy event.

There are now millions of Americans using glucosamine-based dietary supplements. These are the seventh most popular dietary supplement sold in the United States. There are over 20 million Americans affected by osteoarthritis. 111 So when the largest newspaper in the United States ran the headline, “Two Arthritis Drugs Found To Be Ineffective,” they knew it would catch a lot of attention. The fact that glucosamine and chondroitin were labeled as “drugs” is an indication of how little time this newspaper spent evaluating the actual study.

How effective is glucosamine-chondroitin?

In previous issues of Life Extension magazine, we have discussed the studies indicating a significant benefit to arthritic patients who take glucosamine sulfate and chondroitin sulfate. 112-113 It is because of these successful earlier studies that this latest study published in the New England Journal of Medicine was conducted.

While glucosamine-chondroitin have documented efficacy, many arthritis sufferers need to take a broader approach to relieving inflammation, immobility, and chronic pain. Fish oil, for instance, has been shown to help reduce pro-inflammatory eicosanoids such as prostaglandin E2 and leukotriene B4, along with pro-inflammatory cytokines such as TNF-alpha and IL-1b. 114-116 These inflammatory factors play a major role in degenerative joint disease. Over the past 10 years, we have published findings showing benefits when combinations of fish oil, borage oil, glucosamine, and other nutrients are taken together. 117 Sulfur for the Joints

One of the flaws in the New England Journal of Medicine study may have been that the form of glucosamine used did not provide any sulfur.

Animal studies have shown that joints affected by osteoarthritis have lower sulfur content, 118 and that arthritic mice given a sulfur-containing nutrient (MSM) experience less joint degeneration. 119 In a double-blind trial in people with osteoarthritis, study participants who received MSM by itself experienced significant pain relief. 120

In a study published in 2004, the combination of glucosamine with MSM was found to more effective in improving the signs and symptoms of osteoarthritis than either agent alone. 62 After 12 weeks of treatment, the average pain score in the glucosamine-only group dropped from 1.74 to 0.65…a 63% reduction. In the MSM-only group, it fell from 1.53 to 0.74...a 52% reduction. However, in the group taking glucosamine and MSM, the average pain score dropped from 1.7 to 0.36…an astounding reduction of 79%! The researchers also found that the combination therapy had a faster effect on pain and inflammation than either glucosamine or MSM alone.

It is important to point out, however, that some studies have used glucosamine HCL to effectively relieve arthritis pain.

Media tries to bury saw palmetto

More than 20 published studies show that saw palmetto alleviates symptoms associated with benign prostate disease such as frequent urination, low urine stream, and a feeling of not completely emptying the bladder. 121-141

A recent study however, found saw palmetto to be ineffective in men with moderate-to-severe benign prostate hypertrophy. As a result of this one study, the media declared saw palmetto useless.

The doctors who conducted this negative saw palmetto study received financial compensation from Merck (which makes Proscar®), GlaxoSmithKline (which makes Avodart®), and TAP Pharmaceuticals (which makes Lupron®). Proscar and Avodart are drugs that directly compete against saw palmetto, whereas Lupron is used mostly by men who develop prostate cancer.

Some in the alternative medical community have cried “foul,” in as much as the doctors overseeing this negative saw palmetto study received financial compensation from the same pharmaceutical companies that stood to gain the most from discrediting non-prescription herbal therapies such as saw palmetto.

Flaws in saw palmetto study

One of the defects of the negative saw palmetto study is that it evaluated men who had more advanced prostate disease than did most of the participants in the favorable saw palmetto studies. In the numerous European studies that documented saw palmetto’s efficacy, most of the men evaluated were considered to have moderate prostate disease. The study used to attack saw palmetto, on the other hand, looked at men with moderate-to-severe prostate disease. Researchers long ago determined that men with moderate-to-severe benign prostate disease need aggressive therapy to achieve effective relief. This is why recent studies showing positive benefit to herbal prostate remedies have used saw palmetto combined with nettle root. 142-146 This fact raises questions as to why so much money was spent funding a study of men with significant prostate disease using only saw palmetto, when European doctors prescribe combination herbal therapies to treat benign prostate disease.

Another flaw of this study is that the group assigned the saw palmetto had more pronounced prostate disease than did the placebo group. For instance, the group receiving saw palmetto had a BPH Impact Score that was statistically significantly worse than the placebo group at baseline. Whether these baseline differences had an impact on the study’s outcome is unknown. By placing men with more severe prostate disease in the saw palmetto group, however, the study was biased against saw palmetto from the beginning. The Overlooked Effects of Estrogen on the Prostate

Mainstream medicine remains fixated on the role of testosterone and dihydrotestosterone in promoting prostate gland overgrowth. Prostate disease, however, does not strike young men with high testosterone levels

The overlooked fact is that as men grow older, they produce less testosterone and a lot more estrogen. Prostate cells contain estrogen receptor sites, demonstrating that the gland can respond directly to the growth-promoting effects of estrogen. Recent data suggest that estrogens play a role in prostate disease. 147-149

Aging men, in particular those with the so-called pot belly (abdominal obesity), often have excess levels of the aromatase enzyme that converts testosterone into estrogen. The prostate itself expresses aromatase that can convert testosterone into estrogen within the gland itself. Two herbal extracts used extensively in Europe (pygeum and nettle root) have demonstrated aromatase-suppressing effects in vitro, especially when they are used together. 150

Why this study is irrelevant to aging men today

European doctors use various combinations of pygeum, nettle root, beta-sitosterol, saw palmetto, and other herbs to treat benign prostate disease. Despite numerous scientific studies indicating that treatment of prostate enlargement should include a combination of herbal extracts, the doctors who designed the one recent negative study choose to test saw palmetto in isolation.

Based on evidence that prostate disease is caused by several different factors, it would appear that the recent study that used only saw palmetto to treat men with moderate-to-severe prostate disease was designed to fail. The study therefore has no relevance to men taking combination supplements that provide nettle root (Urtica dioica), pygeum, beta-sitosterol, and other plant extracts that have proven efficacy in dozens of published scientific studies. 151-181

It is important to also note that this is only one study of a relatively small group of men with moderate-to-severe prostate enlargement who were only allowed to use saw palmetto. Ten times as many men with varying degrees of prostate disease have participated in other studies that showed even saw palmetto taken by itself to be highly effective. 121-141

Exposing the recent media attack against dietary supplements

Over the past several months, the media has questioned the efficacy of several popular dietary supplements. In the upcoming June 2006 issue of Life Extension magazine, we dissect these negative media reports down to the bone to reveal the hard scientific facts.

In doing so, we expose the absurdity of the headline-hungry media making proclamations such as “another natural remedy bit the dust” when describing the recent glucosamine study. We also reveal the inappropriateness of conventional doctors, with little knowledge about the proper use of nutrients, but with strong financial ties to the pharmaceutical industry, conducting studies that contain so many flaws that their findings are largely irrelevant.

The Life Extension Foundation helps people discover the science behind the headlines in order to avoid being victimized by the medical establishment’s ominous propaganda machine.

P.S.- At the beginning of this letter, I stated that the front page of the Wall Street Journal featured an article stating:

“Design problems in all the trials means the results don’t really answer the questions they were supposed to address. And a flawed communications effort led to widespread misinterpretation of the results by the news media and the public.” 1

It is important to note that like other media outlets, the Wall Street Journal (in other articles) regurgitated the same negative reports about dietary supplements as did the New York Times, Washington Post, Associated Press, et al.

References . . .


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