Resource Centers:(News, information, and tools to support your practice)
June 2008
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Attack on alternative medicine: Is the clock ticking on alternative healthcare?
According to the March 2003 issue of the AARP Bulletin, the American healthcare system is in a state of collapse. In a comparison of quality healthcare by the World Health Organization (WHO), the United States ranked 37th, coming in behind such nations as Andorra, Malta, Oman and Singapore.
Despite the average $4,600 per capita spent for healthcare in the United States — which is more than twice the average of other countries, such as France ($2,125) and Japan ($1,759) — our healthcare system is faltering while costs keep rising.
In most developed nations the government controls and administers some form of socialized healthcare. Costs are carefully controlled and all viable alternatives to expensive allopathic protocols and drugs are considered.
By comparison, healthcare in the United States is in the domain of those enterprises that stand to benefit from expensive medical practices, despite the fact that the American public is developing a thirst for alternative healthcare, as indicated in a 1998 survey reported in the Journal of the American Medical Association, which found that 60 million were using alternative therapies.
FDA actions: At odds with its mission
The power of the medical and pharmaceutical industries has infiltrated agencies of the government that are supposed to protect and serve the interests of the public, not of the industries they regulate. The Food and Drug Administration (FDA) is a prime example of this phenomenon.
The stated mission of the FDA is to protect the public health. The agency is also responsible for helping to speed innovations that make medicines and foods more effective, safer and more affordable.
Yet, on June 15, 1993, the FDA Dietary Supplement Task Force published its report on developing public policy on nutritional supplements and stated, “The Task Force considered various issues in its deliberations, including what steps are necessary to ensure that the existence of dietary supplements on the market does not act as a disincentive for drug development.”
It would seem, then, that the unstated mission of the FDA is to protect drug-industry profits against competition from more effective, safer and less expensive natural alternatives. To illustrate, here are some examples of FDA actions that have not been in the best interests of the American public:
• L-Tryptophan. This is an essential amino acid and a very effective serotonin producer. Elevated levels of serotonin in the body often result in the relief of depression, as well as substantial reduction in anxiety and stress.
In late 1989, the FDA recalled L-Tryptophan. The agency said that this amino acid had caused a rare and deadly flu-like condition. The Centers for Disease Control and the Mayo Clinic investigated the cause of the flu-like condition and did trace its outbreak to contaminants found in batches of L-Tryptophan — manufactured by a Japanese company.
The FDA, however, completely and arbitrarily banned the public sale of dietary L-Tryptophan on March 22, 1990.
Coincidentally, on March 26 — four days following the ban of L-Tryptophan – Newsweek featured a lead article praising the virtues of the anti-depressant drug Prozac. This drug, as well as other anti-depressant drugs such as Paxil and Zoloft, is a serotonin-enhancer, working on whatever amounts of serotonin already exist in the body.
In contrast, ingested L-Tryptophan is a serotonin-producer, making it superior to its drug counterparts.
A 100-count bottle of 500mg capsules of L-Tryptophan sold for $17. A 90-count bottle of 25mg of Prozac sells for $257.
Today, L-Tryptophan is a legal prescription drug sold through a network of compounding pharmacies at approximately $85 for one hundred 500mg capsules — nearly five times more than when it was a dietary supplement.
• Stevia. This is a safe and intensely sweet herb. In Europe and in the Far East, it is a popular non-caloric sweetener and it could hold that potential in this country as well.
However, in 1991 the FDA banned Stevia as an “unsafe food additive.” Thanks to the 1994 dietary supplement law (DSHEA), which allows supplements sold before 1994 to remain on the market unless the FDA can prove they are unsafe, Stevia is now sold as a dietary supplement. The FDA’s stubborn position, though, prevents this herb from being used commercially to sweeten soft drinks or foods and replace less healthful chemical sweeteners now used.
• Kava Kava. This herb has been revered as a calming social beverage in island communities of the South Pacific for nearly three millennia. It gained prominence in the early ‘90s when Germany’s Commission E, a panel of herbal experts in the fields of medicine and pharmacy, evaluated it and approved its use as a nonprescription medicine for “nervous anxiety, stress and restlessness.”
The herb came under fire in November of 2001 when the German government announced that over several years it had found 24 adverse event reports of liver damage reportedly associated with oral use of medicinal kava preparations.
When the FDA heard of this “reportedly adverse event” involving an herb that was known to be effective, safe and less expensive than a comparable synthetic drug, it immediately notified the media and sent out letters indicating that it was investigating whether the use of kava-containing dietary supplements caused liver damage.
The FDA announcements
Prior to the FDA’s pronouncement, kava ranked ninth in sales of all herbal dietary supplements — it has now fallen into disfavor due to the intense media attention fomented by the FDA.
Meanwhile, some over-the-counter painkillers containing acetaminophen were responsible for thousands of liver poisonings a year and were determined to be the leading cause of liver failure in the United States, according to a 2002 study published in the Annals of Internal Medicine. The FDA, however, has never notified the media or sent out letters indicating it was investigating whether the use of acetaminophen-containing OTC drugs caused liver damage.
• Ephedra. also known as Ma huang, it has been a lightning rod for controversy.
This herbal weight-control supplement has been in use continuously for at least 5,000 years and is the oldest medicinal plant of which we have written records. This incredible herb promotes weight loss by producing a thermogenic and fat-metabolizing effect and acts as an appetite suppressant. It works. It is safe under normal conditions of use, has no contraindications and is inexpensive.
In 2001 a carefully conducted, independent, double-blind, randomized, placebo-controlled study reported in the International Journal of Obesity found that the group taking ephedra had significantly greater reductions in waist and hip circumference than the placebo group, with no adverse effects on the subjects during the trial.
Most of the publicized abuses concern the drug ephedrine, which is an alkaloid that constitutes less than 3 percent of the whole ephedra herb.
One of the most publicized cases concerning ephedra was that of Baltimore Orioles player Steve Bechler, who died of organ failure brought on by heat stroke when his body temperature reached 108 degrees.
Bechler had pre-existing high blood pressure, was overweight and had extraordinary demands placed upon him as a professional athlete. He also used an ephedra-containing product, which the medical examiner cited as a “probable contributor” to his death.
The sensationalism surrounding ephedra has been biased and exaggerated – and so successful that even alternative health practitioners now believe this valuable herb is dangerous.
To date, no deaths have been directly attributed to the herb ephedra. By comparison, the drug industry is still smarting from the infamous Fen-Phen scandal, the diet pills that promised weight loss but delivered heart and lung disease instead. Some 300 deaths were attributed to the pills before they were taken off the market. And the danger imposed on the public was for nothing: An independent follow-up study later showed they didn’t even reduce weight.
Newest attack: S 722
Congress is now considering Senate Bill 722, the Dietary Supplement Safety Act of 2003. The bill would amend the Federal Food, Drug and Cosmetic Act to require manufacturers of dietary supplements to submit to the Food and Drug Administration reports on adverse experiences with dietary supplements. (See “Supplements under federal scrutiny” in Newsflash, Issue 11, Chiropractic Economics or at www.chiroeco.com/news/supplement-scrutiny.html.)
The underlying purpose of this bill is to move the burden of proof from the FDA to show that a supplement is not safe to the manufacturer to show that it is safe.
The methodology of this bill hands the FDA a blank check for removing any supplement it chooses from the marketplace, because the report of a single “serious adverse dietary supplement experience” would enable the FDA to require the manufacturer to submit safety data on that product.
S 722 defines “adverse experience” as a negative health experience that is associated with but not necessarily caused by a dietary supplement. The FDA would have the authority to decide whether that safety data was adequate. Given the FDA’s hostile stance on alternative medicine, it is reasonable to predict that the passage of this bill will spell the death sentence for natural alternatives to drugs and consumer choice.
The American public deserves inexpensive and effective alternatives; it deserves to have a choice about its healthcare.
What can we — all of us — do? Several things:
• Band together. In unity there is power. It is time for alternative health practitioners and the natural food and supplement industry to band together.
• Become politically active. Force your Congressional leaders to listen.
• Educate your patients and customers. Tell them the facts about the AMA and the drug industry. Even give them a copy of this article. This may be the most important thing you can do.
It is now the eleventh hour. Don’t let the clock strike twelve.
Galen O. Ballard, PhD, has been with Titan Laboratories since its inception in 1988. In 1999 he was promoted to president .
Dr. Ballard's education includes undergraduate studies at the University of Denver with graduate work at the Universities of Wisconisn and Maryland. He also holds a law degree from Blackstone School of Law in Chicago. He can be contacted by e-mail at gballard@titanlabs.com.
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