This issue is different than the normal newsletter that comes from my desk. I feel this departure from the normal format is necessary because of some disturbing activity with frightening consequences within the alternative and complementary medicine community. We will return to the normal informational and technical format in the next issue.

Ken is currently not allowed to sell, or in fact, to give away Amygdalin or Hydrazine Sulfate. Also, in a clear violation of the first amendment to the US Constitution Ken is not permitted to contact directly or even to send a newsletter to any of his customers to inform them of what their government has done to them. This was done, according to prosecutors, to "Keep Ken from ‘tampering with witnesses’ by contacting his ‘victims’". This is, of course, absurd. The government has no intention of calling any of Ken’s customers as witnesses. Why would they torpedo their own case? Since Ken has stated emphatically that he will not buckle to federal pressure and take any plea bargain there will be a trial. The federal prosecutors will actually fight tooth and toenail to keep these success stories out of the trial. They do not want efficacy made an issue and claim that it does not matter because their experts say these supplements are worthless. This is in fact at the core of their "new drug" assertion because of the ridiculous definition applied by the FDA to this term. By the admission of FDA criminal division agents, water can be regulated as a drug if it is used to treat conditions like dehydration!

Most of the customers who have contacted Ken since this action have confided that they do, indeed, feel victimized but not by Ken. They feel victimized by a government that makes the absurd claim that Amygdalin and Hydrazine Sulfate and other supplements are legal to obtain, possess and use for self-administration but illegal to sell or for a trained physician administer, thus making it increasingly difficult, if not impossible for them to obtain.

As of this writing all known distributors of these critical supplements are either under a restraining order or other court ordered cessation or have voluntarily closed their doors. This is the darkest period for controversial alternative therapies that I have seen in my 27 years of participation in the industry. This is far worse than the dark days of the mid- and late 1970’s when the previous high tide of government effort to end the availability of these items was seen. This is the first time that the government has successfully been able to stop all distribution simultaneously! The seriousness of this situation is just beginning to be known. By the time everyone is fully alerted to the danger it may be too late.

This effort is only a first step. The FDA claims that their actions are intended to "regulate" these supplements and to "protect the consumer". This is Orwellian double-speak for elimination of vital nutritional supplements which threaten the profits of the multi-billion dollar per year orthodox therapy business. The highly regulated orthodox therapy industry deals in an often highly toxic synthetic product which in many cases can perform great healing feats but also kills, maims and destroys the quality of life of thousands in the US alone every year. Yet the FDA thinks an industry which extracts food fractions from plants and animals and generates only a handful of complaints per year, mostly of a minor nature, should be under the same scrutiny and control. The FDA will stop at nothing to reassert its authority over natural food supplements. They are clearly an agency out of control and they feel emboldened by the apparent reckless disregard for the law of the Janet Reno run Justice Department. The Justice Department has encouraged the FTC and FDA to ignore laws that they don’t like and continue to enforce regulations negated by these laws. This MUST be stopped!

As many of you know, the FDA has recently made several attempts to reassert control over nutritional supplements which was severely restricted under the DHSEA (Dietary Health Supplement Act). There have been several attempts to apply "new drug" labels to items that are clearly covered under the conditions of the DHSEA. Amygdalin is one of these since it is, in fact, a botanical. Companies like Life Extension and Lane Labs and other smaller companies have suffered repeated regulatory harassment in the FDA’s and FTC’s efforts to nullify the DHSEA. If the FDA is successful no form of alternative or complementary therapy is safe.

We believe that an immediate concerted and coordinated effort by patients and physicians to contact their Congressmen and Senators is absolutely necessary. Remember this in an election year! All candidates for public office should be closely questioned by the voters and made to give no-nonsense answers to questions about their support for patients’ right to the therapy of their choice.

Many of you are members of physicians’ advocacy and lobbying groups (e.g. ACAM, FAIM, A4M, NHF, People Against Cancer, etc.) which can be of great service in helping coordinate efforts and get the word out. These groups should be contacted by you and urged to redouble their efforts. We will also be contacting them. We are of the opinion that a class action lawsuit against the FDA and possibly the FTC and Justice Department may be necessary. The time for unity against a common enemy is now! Rival groups, factions within those groups and even commercial competitors must put aside their differences in order to defeat the common enemy! Ken Michaelis requests that any of you with clinical experience with alternative therapies, especially Amygdalin and/or Hydrazine Sulfate volunteer to testify as expert witnesses. Expert testimony is pivotal to defeating the government’s case since their definition of a new drug is based on expert opinion.

We ask that doctors and patients call, write or e-mail their congressmen and senators and demand that they support HR 2635 (House) and S 1955 (Senate) the Access to Medical Treatment Act, which is currently bottled up in committee. Also we urge that you and your patients do the same in support of HR 3677 the Thomas Navarro FDA Patient Rights Act. The Holistic Alternatives website, www.holisticalternatives.net, has direct links to the House of Representatives e-mail site and the Senate directory and you and/or your patients can contact congressman directly and look up Senate and House addresses and websites. Holistic Alternatives’ sight also has links to several important alternative and complementary therapy related sites, like Thomas Navarro, Dr. Burzynski, People Against Cancer, etc. You can also find contact information for legislators directly at www.house.gov and www.senate.gov. Please have copies of all correspondence sent to Representative Dan Burton (R-IN) www.house.gov/burton or contact him via regular mail at 2185 Rayburn HOB Washington, DC 20515. Ask Representative Burton to hold investigative hearings in the House Government Oversight and Reform Committee, of which he is the Chairman, into the recent actions of the Justice Department and the FDA. Also, hearings into the FDA’s and FTC’s repeated violations of the DHSEA should be requested. Also ask him to investigate why the FDA Commissioner, Dr. Jane Henney, has reneged on her pledge to US Senators at her confirmation hearings that she would not try to crush alternative and complementary therapies.

We all have a great deal of work to do and a short time to do it in. We can win if we can make our collective voice heard. Please feel free to contact us with questions or comments and please visit the Holistic Alternatives website.

Chuck Michaelis

President, Rocky Fork Formulas, Inc.