GALILEO'S LAWYER:
Courtroom Battles in Alternative Health, Complementary Medicine and Experimental Treatments

"Galileo's Lawyer tells the story of medical mavericks, that is to say health care practitioners who use unconventional, alternative, unapproved, experimental or integrative medical modalities on conditions like cancer, heart disease, fibromyalgia, multiple sclerosis, Lou Gehrig's disease and other conditions. Many of these practitioners use dietary or nutritional supplements, herbal remedies or homeopathic products to treat disease or for disease prevention. Many of the treatments used by medical mavericks are not approved by the FDA (Food and Drug Administration). The government, insurance companies and the medical establishment sometimes try to stop these practitioners from treating patients through the use of medical board proceedings, criminal actions and civil lawsuits. This book tells the story of the fight between alternative or complementary health practitioners, their patients and the government." - Richard Jaffe

We, Mark and Marianne Hershiser, husband and wife, own and operate Native Essence Herb Company, located just outside Taos, New Mexico. We started this small, family business in 1993 and have enjoyed running it ever since. We have always ran a good, honest, ethical business. Recently, the Federal Trade Commision (FTC) made accusations that "native essence has engaged in unfair or deceptive acts or practices... by claiming that [cat's claw, astragalus, maitake, etc.] can, among other things, prevent, treat, and/or cure, serious diseases..." The FTC's claim of "unfair or deceptive acts or practices" was based on the posting on our website of truthful, educational information on the well documented, traditional and historic use of these herbs.

We believe the FTC's prohibition of this kind of truthful, educational information is unreasonable and unconstitutional so we have filed a suit to strike down the FTC's guidelines. (see complaint)

In addition to posting information, the FTC also advised our attorney that is illegal for us, or any other company which sells herbs to the public, to have a link to any site, even a not-for-profit educational site, if the site states or implies that an herb can assist in the prevention or cure of a disease. This would also include a truthful statement that an herb or plant has a documented historical native use for the treatment of disease. Thus, if we were to have a link to an educational, herbal information site such as the American Botanical Council (ABC) and that site indicated that Traditional Chinese Medicine used astragalus root for the treatment of disease, the FTC would view us as acting illegally for making an unsubstantiated health claim.

Here is a specific FTC "violation" regarding the use of Chinese astragalus root, this is the information we had posted on our website: "Astragalus root has also been indicated as an aid in the side effects of chemotherapy as well as having the ability to inhibit tumor growth. If taken cumulatively, especially with Chinese Ligustrum (Privet) fruit, it shows marked anti-tumor properties."

Here is information regarding Chinese astragalus root that is available at the National Center for Complimentary and Alternative Medicine (NCCAM), a federal government website, the site also states "Duplication is encouraged": "Historically, astragalus has been used in traditional Chinese medicine, usually in combination with other herbs, to support and enhance the immune system. It is still widely used in China for chronic hepatitis and as an adjunctive therapy in cancer." "A few studies have shown potential benefits for using astragalus—in combination with another herb, glossy privet (Ligustrum lucidum)—as an adjunctive therapy for cancer."

Here is information the American Cancer Society (ACS) has available on their website regarding Chinese astragalus root: "May improve functioning of the immune system and might possibly enhance the effect of conventional immune therapy for some cancers. There is some suggestion that it may enhance the effects of certain chemotherapy (cancer treatment) drugs, but more testing is needed. The herb is promoted to kill cancer cells, reduce the toxic effects of chemotherapy..."

In an effort to "redress injury to consumers" allegedly caused by the information that we provided on our website, as shown above, the FTC threatened to sue Native Essence Herb Company, as well as myself and my wife as owners/operators of our small, family run business. Please note, we have been in business for 15 years and have never received a single customer complaint regarding this, the only complaint comes from the FTC, so it was not clear what injuries this money was to redress. Certainly if our customers had complaints or injuries this might make sense, but there have been none.

With no complaints, and no injuries, the FTC still forcibly proposed a settlement. They suggested a settlement would be much easier on us than a lawsuit against us, a lawsuit that was implied to be expensive, uncomfortable, time consuming and life changing. Their proposed settlement included our signing an order that would permanently censor us, as well as force us to forfeit all revenues earned through the lawful sales of these herbs. Failure to comply with these demands and settle or pay this (undisclosed, without our first providing detailed personal and corporate financial disclosure statements) amount of money within 10 days of receipt of documents could result in a court order to seize our company, to appoint a receiver to "exercise control over [Native Essence Herb Company] while this matter is pending" and to freeze our assets, which would deprive us of the ability to defend ourselves in any FTC proceeding. Apparently, this is common practice with the FTC, to freeze the assets of small companies without a trial, hearing, or any due process whatsoever, eliminating the ability of small companies to properly defend themselves. Thanks to Richard Jaffe, our attorney, this didn't happen.

Perhaps this is why this issue has never been litigated in a court of law and why Congressman Ron Paul felt the need to introduce into congress the Health Freedom Protection Act, H. R. 2117, ("...to amend the Federal Trade Commission Act concerning the burden of proof in false advertising cases..."). To quote Congressman Ron Paul from his speech to congress regarding this issue:

"This legislation also addresses the FTC’s violations of the First Amendment. Under traditional First Amendment jurisprudence, the federal government bears the burden of proving an advertising statement false before censoring that statement. However, the FTC has reversed the standard in the case of dietary supplements by requiring supplement manufactures to satisfy an unobtainable standard of proof that their statement is true. The FTC’s standards are blocking innovation in the marketplace."

"The Health Freedom Protection Act requires the government bear the burden of proving that speech could be censored. This is how it should be in a free, dynamic society. The bill also requires that the FTC warn parties that their advertising is false and give them a chance to correct their mistakes."

We received no such warning. The FTC attorney's said they sent a warning email in August 2007 to our commercial email address. Unfortunately, we never saw this email and unfortunately, we get alot of spam at our commercial email address. We believe the FTC should be required to send a certified return receipt letter through the US Postal service to insure that parties such as us actually receive these warnings if they believe their warnings address legitimate public health issues that allegedly cause "injury to consumers."

We definately received the threatened lawsuit papers, certified return receipt, multiple physical copies to multiple physical addresses, in April 2008. We do not believe the information we posted caused any injury to consumers, and we do not believe the FTC attorney's thought so either. If FTC attorney's beleived we were providing "false and misleading information" that was causing "serious and immediate harm" in August 2007, they would have had us remove the alleged false information in August 2007, not in April 2008.

None of the information we posted, or linked to, was false or misleading, the information was historically factual and certainly not exclusive to us or our website. All the information can be readily found throughout the internet as well as in books and printed material available at bookstores and libraries. Much of the information is available on Federal Government websites such as this information on astragalus available here, provided at the National Center for Complimentary and Alternative Medicine (NCCAM), or this information on kelp available here, that comes from the National Library of Medicine (NLM). Even the National Cancer Institute (NCI) claims shiitake, kelp, sorrel, turkish rhubarb, red clover, watercress and blessed thistle, may have anticancer effects. There are many more examples of information such as we posted available at sites such as the American Cancer Society, Memorial Sloan-Kettering Cancer Center, etc. This educational information was not misleading in any way and has never caused any injury to any consumers. Furthermore, we believe we have the right to share this type of truthful, historical use information with our customers.

The Supreme Court has spoken clearly on this issue of the right of the public to truthful, commercial information:

"If the First Amendment means anything, it means that regulating speech must be a last - not first - resort."

"We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information."

"Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring ... a warning that the drug had not undergone FDA testing and that its risks were unknown." - US Supreme Court

(Thompson v. Western States Medical Center - 01-344, decided on April 29, 2002 - 535 U.S. 357)

To clarify our intentions regarding the information we presented, every page of our website had a detailed warning/disclaimer stating the information presented was anecdotal, that these herbs had not been proven by scientific clinical trials and were not intended to be used in place of a licensed medical practitioner. The disclaimer reads as follows:

Important notice:

This information is to be used for educational purposes only and has been based solely on the traditional and historic use of a given herb, or on clinical trials that are generally not recognized by any US government agency or medical organization. This information has not been evaluated by the US Food and Drug Administration, nor has it gone through the rigorous double-blind studies required before a particular product can be deemed truly beneficial or potentially dangerous and prescribed in the treatment of any condition or disease.

Furthermore, the information presented here is not presented with the intention of diagnosing any disease or condition or prescribing any treatment. It is offered as information only, for use in the maintenance and promotion of good health in cooperation with a licensed medical practitioner. In the event that any individual should use the information presented on this website without a licensed medical practitioner's approval, that individual will be diagnosing for him or herself. No responsibility is assumed by the author, publisher or distributors of this information should the information be used in place of a licensed medical practioner's services. No guarantees of any kind are made for the performance or effectiveness of the preparations mentioned on this website.

End of Notice.

Was this disclaimer not clear enough? What more exactly should we have said to better convey this information to visitors of our site? We certainly never intended for anyone to feel "misled or decieved" in regards to the historical use information we presented and our customers have never felt they were "misled or deceived." (See customer feedback)

Until this matter is resolved, and as a sign of good faith, we have removed all links, all customer comments, and all traditional and historic use information from our website. Our removal of this information in no way constitutes an admission of any wrongdoing, violation of any law, or that the information was misleading in any way.

My wife and I do not believe we have done anything wrong and neither do our customers (see customer feedback). Therefore, we have decided not to settle with the FTC, and instead have filed a suit (see complaint) to overturn the FTC's advertising guidelines and seek a judicial ruling allowing ourselves and all other sellers of herbal remedies to provide consumers with information found on government websites such as the National Center for Complimentary and Alternative Medicine, the Office of Dietary Supplements, the National Library of Medicine, Pub Med, etc., as well as other well recognized, legitimate sources such as the American Botanical Council, Natural Standard (the NIH source of information), Natural Medicines Comprehensive Database, etc., and well respected publications such as Herbal Drugs and Phytopharmaceuticals, the Encyclopedia of Dietary Supplements, the Scientific Validation of Herbal Medicine, etc.

In a two hour conference call with myself, my attorney, and two western division FTC attorney's, the FTC attorney's stated that if we were to post, or provide a link to, the herbal information available on government websites, they would not "personally" come after us. They stated that since the information was provided by another government agency, it was probably truthful and accurate. They did not agree with the information, but they did not believe they were in the position to dispute it. They would not put this in writing, as our attorney requested, all they would say was that we had their "personal assurance" that we would not be attacked by these two FTC attorney's in the future, if we posted this information, or provided a link to it, on our website. Information not unlike the information we were previously providing. When asked if the FDA might view this information as illegal, they stated we would have to ask the FDA ourselves, they were not sure what the FDA's position would be on this. How reassuring? When our attorney questioned whether this "personal assurance" would extend to future FTC personnel, should these two FTC attorney's that were offering us this personal deal retire or go into private practice while we were still in business, they said we should not concern ourselves with that as they will not be leaving the FTC anytime soon.

In this conference call the FTC attorney's also agreed to settle with us for an undisclosed amount of money? The undisclosed amount would be based on our first providing detailed personal and corporate financial disclosure, this before they could give us a final settlement amount. They assured us this was not a fine as the money would not go to the treasury, but rather would be used for consumers that might have injuries due to the truthful information we provided. Again, they did not cite a single customer complaint or injury.

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