Natural Solutions Foundation

The medical industry has allowed itself to become the drug distribution system of the Pharmaceutical industry. And the prestigious and supposedly neutral medical journals are prime tools in that distribution system since they appear objective and are consulted by doctors for trustworthy and accurate information which they can rely upon to guide the treatment of patients. It is therefore both dangerous and ominous to consider the profound lack of objectivity and corruption which permeate even the most respectable of medical journals.

Advertising revenues for drugs keep them in business. Peer reviewers (who are supposed to keep the system honest) have considerable financial ties with pharmaceutical companies – the more revered the reviewer, the more lucrative the ties. “Research studies” are funded by the companies that stand to benefit from positive outcomes with predictable results. In fact, in many cases, senior authors put their names to research they did not conduct and articles written by company ghost writers. To make matters worse, the data of the studies are owned by contract not by the author (as the case used to be) but by the funding organization so results can be manipulated by the funder despite what the did or did not show.
FDA committee and task force members, too, have significant financial ties to industry. Drug related objectivity is, for the most part, in the mind of the beholder since it is not in the bank account of either the journal or the scientist.

Is it any wonder, then, that highly prestigious and [supposedly] objectivemedical journals participate in propagating the on-going poison press designed to wear away America’s allegiance to natural health options?

Our $20 billion per year supplement spending means that people don’t buy as many expensive and dangerous drugs as they would if they were not protecting their health naturally. That is a real problem for the illness care industry since healthy people are bad customers for the illness industry. That means that our supplement habit must be broken for current profits and the future. The Codex agenda is to making nutrients available only at doses so small they have no impact on any human being is to be brought to the US.

You see, the will of the American people and their legislators to keep DSHEA (the 1994 Dietary Supplements Health and Education Act) intact has to be broken, too. DSHEA says that nutrients are considered as foods and, as such, have no upper limit. The Codex Vitamin and Mineral Guideline says that nutrients are to be considered only in terms of their risk; the WHO guidance on the matter says that ANY CHANGE IN A BIO-MARKER (e.g., anything that can be measured) CAUSED BY A NUTRIENT IS AN ADVERSE EVENT!

The propaganda war is on, big time. Read what Peter Chowka, long time health journalist, has to say about the latest participation by the medical journals.

Saturday, Apr. 15, 2006

Recent Negative Studies of Alternative Medicine:
Bad Medicine or Bad Reporting?

© By Peter Barry Chowka

(April 15, 2006) In recent weeks, the news hasn’t been good for alternative medicine. First came the stories, reported prolifically in the mainstream media, that low-fat diets don’t help to prevent breast or colon cancer or heart disease. This reporting was based on three studies that were published in the February 8, 2006 issue of JAMA (the Journal of the American Medical Association), one of the world’s leading medical journals. That same week, another prestigious scientific publication, the New England Journal of Medicine (NEJM), in its February 9 issue published a study contending that one of the most commonly used herbs, saw palmetto, was no better than placebo for the treatment of benign prostatic hypertrophy or enlarged prostate.

That article was the opening salvo in a new, ongoing series of critiques of alternative medicine in the pages of the NEJM. In the February 16 issue, two studies called into question the effectiveness of using vitamin D and calcium to reduce the risks of bone fractures and colorectal cancer – conditions that have been found in previous studies to benefit from calcium and vitamin D supplementation. The following week (the February 23 issue of the NEJM) another study appeared, proclaiming the uselessness of the nutritional supplements glucosamine and chondroitin for osteoarthritis.

What these negative studies have in common is that the diets or supplements that were being tested have all been previously studied or subjected to review, with consistently positive findings. In fact, a list of the positive studies and references indicating the benefits of low-fat diets, calcium, vitamin D, saw palmetto, glucosamine, and chondroitin sulfate would be quite extensive.

But typically, as soon as the media catch wind of (or read a press release about) a negative study, they tend to exhibit selective amnesia, forgetting or ignoring all of the positive studies that preceded it.

The recent negative studies may have attracted the media’s attention because they appear to go against previously held beliefs – particularly in regard to the presumed benefits of low-fat diets and calcium/vitamin D supplementation. If the results of a new study had indicated instead that low-fat diets prevented heart disease or calcium supplements provided bone protection, they would probably never have made it on the nightly network TV newscasts or in wire service stories. Such news would have been met with a ho-hum, “What else is new?” shrug from most mainstream media producers and editors.

As in the case of any scientific study, however, the published results of these recent negative ones were not as black and white as the media portrayed them to be. The inaccurate or incomplete reporting is partly the result of the limitations of the sound-byte driven news business and also accountable to the somewhat misleading way that the researchers reported the conclusions in several of the studies.

Low-fat Diet Effects on Heart Disease and Cancer

The Women’s Health Initiative Dietary Modification Trial (which began in 1991), the source of the conclusions in the February 8 JAMA articles, was designed to determine the potential long term effects of a low-fat diet on the risk of heart disease, stroke, breast cancer, and colon cancer in 48,835 postmenopausal women, ages 50-79. The study goal was to decrease total dietary fat to 20% and increase the consumption of fruits and vegetables to five servings daily and whole grains to six servings daily. The dietary intervention group was then compared to a control group of women who were not asked to make dietary changes but who were given diet-related educational materials.

This type of study is problematic for many reasons. In the real world, an individual’s dietary changes are usually made gradually, over a long period of time. In fact, in the JAMA articles, by the sixth year of the study the participants in the low-fat dietary intervention group had only decreased their fat intake by 8.2% and the saturated fat intake (the fat most often associated with heart disease) by only 2.9%. In addition, in the low-fat group there was an average daily increase of only 1.1 servings of fruits and vegetables and 0.5 servings of whole grains. Even with these somewhat subtle dietary changes, however, there was a trend toward decreased heart disease and breast cancer incidence in the study participants who consumed the lowest levels of saturated- and trans-fats and in the ones who ate at least 6.5 servings of fruits and vegetables daily. These positive trends are important since the protective or preventive effects of a low-fat diet can take many years, if not several decades, to be fully realized.

Another significant problem with the negative JAMA studies is that the participants in the dietary-change groups were asked to reduce total dietary fat to 20%. Such a blanket recommendation does not take into account the fact that there are “good fats” and “bad fats.” Thus, this group may have been decreasing heart-healthy omega-3 fatty acids, such as the ones in salmon and other cold water fish. These same fatty acids have been found in numerous studies to help prevent cancer.

Saw Palmetto and Enlarged Prostate

The New England Journal of Medicine kicked off its latest series of articles on alternative medicine on February 9, 2006 with the publication of a study on the herb saw palmetto for the treatment of enlarged prostate (benign prostatic hyperplasia or BPH). The study’s design looked good, the dosage of saw palmetto seemed appropriate, and the herbal product that was used appeared to be of high quality. The study may have been compromised from the outset, however, by the choice of study participants – men with moderate-to-severe prostate enlargement. Previous studies on saw palmetto have usually looked at men with mild-to-moderate BPH.

The design of the February 9 NEJM study brings to mind an earlier one, published in 2002 in JAMA, on St. John’s wort for moderately severe major depression in which the dosage used was one that had been found in previous studies to benefit people with mild-to-moderate depression. Rather than confirm these findings in a group with milder depression or increase the dose to one that had been noted in clinical reports to benefit people with more severe depression, the researchers used the lower dose and then concluded that St. John’s wort was useless for the treatment of depression. A similar negative conclusion (including the failure to indicate that the study was in men with moderate-to-severe benign prostatic hyperplasia) was drawn by the saw palmetto researchers: “In this study, saw palmetto did not improve symptoms or objective measures of benign prostatic hyperplasia.” This conclusion, of course, is the bottom-line one that was fed to the media, most of whose representatives no doubt did not read or carefully analyze the study itself.

It is not unusual for the conclusions of a medical journal’s article or study, or the press release issued by the publication promoting it, to be negative, while the details of the complete study suggest a more nuanced, inconclusive, or even positive picture.

In the case of the NEJM saw palmetto study, it seems doubtful that men who have found that the herb helps to keep them from having to get up five times a night to urinate will stop taking it because of this single study. But the negative reporting will likely deter others who might have experienced benefits from using this safe and effective herbal alternative.

Calcium and Vitamin D for Decreasing
Fracture Risk and Preventing Colon Cancer

The fact that calcium and vitamin D are important to bone health is fairly well established accepted. Less widely known, but supported by significant positive research, is the fact that both calcium and vitamin D appear to offer protection against certain types of cancer, including colon cancer. Therefore, it was surprising when the news reported that a study in the February 16 issue of the New England Journal of Medicine had concluded that calcium and vitamin D do not prevent colorectal cancer or bone fractures.

One of the more questionable reports in the print media about the February 16 study was published in The New York Times on February 15. The Times article, “Study Finds Calcium Supplements Don’t Prevent Broken Bones,” opened with the following statement: “Calcium and vitamin D supplements increased the risk of kidney stones but did not prevent broken bones or colorectal cancer in middle-aged and elderly women, according to an extensive study whose results are to be published Thursday.”

It’s not hard to understand why the media would get it so wrong since the concluding statement in the official abstract of the published study, “Calcium plus Vitamin D Supplementation and the Risk of Fractures,” states: “Among healthy, postmenopausal women, calcium with vitamin D supplementation resulted in a small but significant improvement in hip bone density, did not significantly reduce hip fracture, and increased the risk of kidney stones.”

A closer look at this study reveals that it was also part of the Women’s Health Initiative (described above in the section on the low-fat diet studies). The bone fracture-colon cancer study included 36,282 postmenopausal women, ages 50-79 years. They were randomly assigned to receive either 1,000 mg of calcium in the form of calcium carbonate and 400 IU of vitamin D or placebo pills. The study’s protocol was confusing and the conclusions raised more questions than they answered.

Many of the women (16,089) were also enrolled in the hormone replacement arm of the study, confounding the results because hormone replacement can have a significant effect on bone density. Women in both the calcium/vitamin D group and the placebo group were also allowed to take personal calcium supplements (up to 1,000 mg daily) and vitamin D supplements (up to 600 IU daily – 1,000 IU daily after 1999) outside of the study as well as other medications for bone health.

Despite all of these significant variables, the study resulted in a 12% overall lower rate of hip fracture in the calcium and vitamin D treated group compared with the placebo group. The study’s authors deemed this result to be not statistically significant. However, when the supplement group was analyzed for compliance it was determined that participants in the group who took at least 80% of the assigned supplements had a 29% decrease in hip fractures. A major question is why non-compliers were even included in the final analysis. In addition, when the women were stratified according to age, those age 60 and older – the group most likely to suffer from hip fractures – experienced a 21% decrease in hip fractures, even when the study didn’t remove the non-compliers.

The calcium/vitamin D group had a 17% greater likelihood of kidney stones. While the increase in kidney stone rate was reported widely, none of the positive results reached the attention of the mainstream media, even though the increased likelihood of kidney stones was less than the improvement in the hip fracture prevention rate. It should also be noted that the form of calcium used in the study was calcium carbonate, one of the more poorly absorbed forms of calcium. Had the researchers used a more absorbable form of calcium, for example, calcium citrate, they would probably have gotten better results and even decreased the risk of kidney stones, since citric acid (citrate) has been found to help prevent the most common type of kidney stone.

Since this same group of people was analyzed for the effects of calcium and vitamin D on colorectal cancer, some of the same problems with the study design apply – for instance, the fact that the placebo group was also allowed to take significant amounts of personal vitamin D and calcium. In addition, the study lasted seven years and, due to the length of time it takes for cancers to develop, this may have been too short a period to observe a truly beneficial effect of vitamin D and calcium in preventing cancer – a fact that was acknowledged by the researchers (but not in most media reporting).

Glucosamine and Chondroitin for Arthritis

In the study on glucosamine and chondroitin published in the February 23 issue of the New England Journal of Medicine, these two commonly used nutritional supplements for arthritis were compared to the anti-inflammatory medication celecoxib or to placebo. The study randomly assigned 1,583 people with osteoarthritis of the knee to receive 1,500 mg glucosamine HCl, 1,200 mg chondroitin sulfate, a combination of glucosamine and chondroitin, 200 mg celecoxib, or placebo for 24 weeks. People in all groups were allowed to take up to 4,000 mg acetaminophen (Tylenol) daily if necessary. The groups were further divided according to pain severity with 1,229 in a group with mild pain and 354 in a group with moderate-to-severe pain.

The study design was reasonable, although one might ask why glucosamine HCl was used, rather than glucosamine sulfate, since the majority of positive studies of glucosamine for arthritis used the sulfate form. The results reported by the researchers seemed accurate and relatively unbiased, and included the following conclusions: “Glucosamine and chondroitin sulfate alone or in combination did not reduce pain effectively in the overall group of patients with osteoarthritis of the knee. Exploratory analyses suggest that the combination of glucosamine and chondroitin sulfate may be effective in the subgroup of patients with moderate-to-severe knee pain.”

In fact, the combination supplement was significantly effective in the group of participants that needed it most – the ones with the most severe pain. On the scales used to analyze benefit, those taking the combination of glucosamine and chondroitin experienced significant benefit – 24.9 percentage points higher than placebo. This improvement was compared to the effects observed in the group taking the anti-inflammatory drug celecoxib that resulted in only 15.1 percentage points improvement over placebo. Yet, the mainstream media reportage on this study was simply that glucosamine and chondroitin don’t work for arthritis. There was no mention that it does work in those who need it most or that celecoxib may not work so well, either.