The struggle for freedom of medical choice is THE political issue of the new millenium. Therefore, it is extremely important that consumers, healthcare professionals, and legislators be both educated to, and aware of, the current progress & obstacles regarding the growing global acceptance of alternative medical therapy, and its ability to compliment allopathic medicine. This web page will provide a small portion of this type of information, featuring "Alternative Medicine in the Spotlight".

THE ACCESS TO MEDICAL TREATMENT ACT

Please take the time to educate yourself on this legislation, and please email your congressman and senators with your views of this important Act.

The United States leads the world in exceptional medical care, and the Food and Drug Administration (FDA) plays an essential role in evaluating the safety and efficacy of medical treatments to protect our citizens. The current health care delivery system, however, effectively excludes the development and utilization of non-harmful alternative medical treatments that may help patients, contain costs, and generate new approaches to treating illness and chronic conditions. In a free market system, it makes good sense to open up the health care delivery system to alternative treatments, under carefully-circumscribed conditions.

The FDA approval process discourages innovation. The time and expense currently required to gain FDA approval of a treatment (an average of 10 years and $300 million) works to limit participation in this system to only large pharmaceutical companies and to only those products that can eventually be patented. It effectively precludes the innovative contributions of individual practitioners, scientists, and smaller companies that do not have the financial resources or expertise to complete the arduous FDA approval process. It also prevents many low-cost, natural and holistic treatments from gaining access to the market.

Current medical approaches are not making sufficient progress toward combating degenerative and chronic diseases. Pharmaceutical drugs and high tech approaches have proven quite effective in treating many infectious, communicable diseases such as pneumonia, meningitis, and smallpox, in responding to medical emergencies. They have not been nearly as effective in treating degenerative diseases such as arthritis, Alzheimer's, heart disease, diabetes or cancer. Greater attention should be devoted to the growing need to develop new and more effective ways to treat these chronic conditions that plague millions of Americans.

This legislation would allow consumers to be treated by any health care practitioner who is legally authorized to provide professional health services in their state, with any method of medical treatment the individual desires, so long as:

• the treatment causes no harm more serious that reactions experienced with routinely used medical treatments for the same condition;
   
• the patient is fully informed about the treatment and its possible side effects;
   
• the patient is fully informed that the treatment has not been approved by the FDA; and
   
• there is no advertising or marketing of the product or treatment.

FDA's role remains the same. The Access to Medical Treatment Act would not dismantle the FDA nor allow pharmaceutical companies to circumvent the agency. The FDA would attempt to open up a closed system to the utilization of alternative and complementary treatments. The strict claims restriction in the bill is designed to ensure that no incentive exists for major marketing efforts of non-FDA approved treatments, and should address the legitimate concern that this legislation merely establishes a "bypass" for the FDA approval process. In addition , the Federal Trade Commission Act prevents pharmaceutical companies from marketing and advertising non-FDA approved drugs.

This is a freedom of choice issue. Freedom of choice is one of the bedrock principles upon which our nation rests. Permitting the use of alternative medial treatments, provided that individual are not misled or misinformed , extends freedom of choice to American consumers, ensures their access to the full range of therapies, increases their heath care options, may significantly lower health care costs, and increases market competition. This legislation stems from the conviction that an individual suffering from a life-threatening or otherwise serious disease, for which conventional medicine offers limited hope or unacceptable side-effects, should not be denied access to a non-conventional treatment, it there is no evidence that it is harmful and every expectation that if could be efficacious.

Not all Representatives nor Senators have email addresses, but here is a link to a good listing of those that do:

http://www.webslingerz.com/jhoffman/congress-email.html

For specific information from the major proponent of this legislation:

Oregon Rep. Peter Defazio: pdefazio@hr.house.gov

Support the newly introduced Access to Medical Treatment Act bill now under discussion in the U.S. House of Representatives (HR 746) and the Senate (S578) by writing your U.S. Representatives and expressing your desire to have this bill passed into law. This bill will allow an individual to be treated by any licensed or legally authorized health care practitioner of any treatment method desired.

Codex Alimentarius Commission - Global Plot to Suppress Herbs?
 

The future availability and legal status of herbs in the U.S. may be determined by the standards set by a 146 member nation committee called the Codex Alimentarius Commission operating in conjunction with the United Nations and the World Health Organization (WHO). According to critics, under the guise of protecting public safety by standardizing food and botanical codes, the Commission may be a tool of the international pharmaceutical industry that is intent on making herbs available by prescription only.

The Commission was established in 1962 to set international standards and codes for foods. Since then, it has published 237 food standards, 41 hygienic codes, and safety regulations for food additives and pesticides. In 1995, the Commission's German delegation introduced a set of proposed draft guidelines for dietary supplements to the Codex Committee on Nutrition and Food for Special Dietary Uses.

These codes were based on how things work in Germany where the major drug companies have managed to make a great number of supplements available only by prescription. If passed, the German regulations could block the use of supplements for preventive or therapeutic purposes, severely hamper consumer access by stipulating acceptable potencies and dosage levels, and become the International Reference Standard for the U.S. through its preexisting trade treaties such as NAFTA and GATT. All new dietary supplements would be automatically banned unless they passed the Codex approval process, potentially as burdensome and expensive as that of the FDA for new drugs. In effect, the Codex regulations would reposition supplements as drugs.

The standards would probably be more restrictive than anything the FDA has yet proposed, states Frank Cuny of California Citizens for Health in Oroville, California. "It will limit our freedom of choice here in America and in other free nations. It would be a disaster to the health food stores and the health food industry." That view is shared by John Hammell, political coordinator for the Life Extension Foundation in Hollywood, Florida, which distributes supplements and a health magazine. "The German proposal threatens to destroy the dietary supplement industry, enabling the pharmaceutical industry to take over all natural products as expensive, patented drug analogs," says Hammell.

According to Hammell, although U.S. representatives to the Commission (including FDA officials) have opposed the German guidelines, the U.S. has only one vote on the Commission. In October 1996, the Canadian delegate, Mary Cheney, M.D., of that government's Health Protection Branch, proposed creating a list of herbs from which the public needs protection; this proposal was supported by Elizabeth Yetley, M.D., of the FDA.

In Hammell's view, this represents the early stage of "a con job on a global scale, a shell game" in which the international drug cartel would shift the regulation of herbs and supplements away from the Commission (which would regulate them as "foods") to WHO jurisdiction (which would see them as "drugs").

The German and Canadian proposals, if passed, would constitute an effective end run by the drug companies around the medical rights of Americans. "They wouldn't dare do in the U.S. what they are attempting to do here because there would be such a public uproar it wouldn't go through," observes Mark Davidson, D.O., of the Circle of Life Health Center in Asheville, North Carolina.

The drug companies are planning a "global takeover of the vitamin-herb industry" in the next few years by regulating access and pushing competitors out of the field, says Dr. Davidson. "They are planning to do it quietly and carefully through GATT and the Codex Commission and they will succeed if they are not exposed and their plan given national headlines."

SOURCES: Life Extension Foundation, P.O. Box 229120, Hollywood, FL 33022-9120; tel: 800-841-5433 or 954-766-8433; fax: 954-761-9199; website: http://www.lef.org. California Citizens for Health, P.O. Box 2260, Boulder, CO 80306; tel: 800-357-2211 or 303-417-0772; fax: 303-417-9378; e-mail: cfh@ares.csd.net.

Express your dissatisfaction with developments at the Codex Alimentarius Commission by writing the U.S. and Canadian representatives. Elizabeth Yetley, M.D., Director, Office of Special Nutritionals, HFS-45, U.S. Food and Drug Administration, 200C St. S.W., Washington, DC 20204; tel: 202-205-4168; fax: 202-205-5295. Mary Cheney, M.D., Chief, Nutrition Evaluation Division, Food Directorate, Health Protection Branch, Tunney's Pasture, Postal Locator 2203A, Ottawa, Ontario K1A 0L2 Canada; tel: 613-957-0352; fax: 613-941-6636.
 

Herbal Medicine and the FDA
On December 14-16, 1994, in Washington DC, there was a symposium on Botanical Medicine sponsored by the National Institute of Health (NIH), the office of Alternative Medicine (OAM), and the Food and Drug Administration (FDA). The purpose of the meeting was to better define how herbs can be integrated into conventional healthcare.

The main discussion revolved around a couple of very important issues, namely establishing the safety and efficacy of herbs, how to regulate herbal medicine, and whether herbs need to be classified as drugs. Devra Lee Davis, who is the senior advisor to the assistant secretary of health, emphasized that the government would like to forge ahead with a scientific agenda to establish the credibility of herbal medicine. She pointed out that cancer therapy has not changed much in the last 30 years and that herbal medicine contains great promise for that and other diseases.

Many of the discussions that followed pointed out that herbs are useful for treating many diseases but they are also dangerous if improperly used or if there is no quality control employed in their manufacture.

Current U.S. regulations require the proper documentation of research to show the validity of effect and the safety of the product. If one wishes to label an herbal product as being effective to treat a medical condition it would fall into the category of a drug and would have to show valid research. The FDA explained that according to the new Dietary Supplement Bill that passed Congress in 1994, herbs are in the Category of "dietary supplements" and can be marketed freely as long as there is no medicinal claim made on the label. If there is a claim then it is illegal to market the product unless it has been approved as either an Over the Counter or Prescription drug. The FDA urged people to do responsible research and validate their claims. They also expressed the same desire as the herbal medicine industry to find new medicines that are safe and relatively free of side effects.

The main example of herbal medicine that was debated was garlic. Proponents of herbs argued that if garlic is useful to lower cholesterol then it would suddenly become a drug. The FDA countered by saying that was true, but only if the garlic was available in bottles with labels that claimed that it was effective for lowering the cholesterol. In the absence of claims on the label, the FDA indicated that they have no jurisdiction.

There will be a presidential commission to research the subject and hopefully this was the beginning of establishing a meaningful dialogue.

Clearly the key to integrating herbs into the healthcare system of American will be research done using the double blind randomized trials. In the absence of research, health claims will not be able to be made. For Chinese herbs that come in bottles, the label will not be allowed to include indications.

The FDA assured the acupuncture community that they do not regulate medical practitioners and they have no problem with acupuncturists giving herbs to their patients, however, they stated that they would urge caution in using all herbal medicines from China as they feel there is no quality control and some products contain drugs or toxic ingredients that have been shown to be dangerous or even fatal.

For the next two years, Chinese herbs will be classified as "Dietary Supplements" and will be regulated as such.

Go to Top