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Operation Cure All

Something very disturbing happened recently. The long arm of the government just got longer. Going by the name of Operation Cure All, the FDA and the FTC have launched a campaign to cure themselves of all competition. Apparently, the growing popularity of alternative medicine and sales of health products are putting a dent in big medicine's pockets. So much so, that they've launched a serious campaign on and offline against it. The government's proclaimed goal is protecting the health of citizens. To that end, testimonials are basically deemed unsubstantiated and deceptive unless they follow stringent rules and legalities set up by the government. One of these rules is that testimonials and endorsements must be backed up by "competent and reliable scientific evidence" (i.e., scientific tests, analyses, research, and studies). While this sounds commendable, what does this really mean?

It means that unless there are clinical studies, research, tests and analysis behind even the most mundane statement, it cannot be used. Most of us are not qualified to do scientific research, nor do we have the money to hire a scientist to do it for us every time we want to give a testimonial. The government requires that testimonials cannot imply that they treat, cure, prevent, or mitigate any disease. What makes it difficult is that exactly what is permissible and what is not is extremely complex and baffling. The average person could not possibly understand the 50 pages the FDA takes up explaining the regulations and all their intricacies without a skilled lawyer. In addition, there are only certain ways testimonials can be structured, called "structure/function" rules. In most cases, a genuine statement from an average person would not fill the criteria of "structure/function."

Even if someone were aware of the stringent rules that applied, it would be very difficult for anyone but a skilled lawyer to give an acceptable testimony. Since very few testimonies are legal, this nearly completely and conveniently eliminates using them. As an added burden, if all the correct documentation exists and the testimony is structured correctly, a report must be filed with the FDA within 30 days of using the testimony. It appears the government has found a way to tie the hands of Internet health companies so that testimonies about their products cannot be heard. Another one of the new regulations is under the guise of 'deception.' While I agree that advertising should not be misleading, it is now illegal for health websites to mention the name of a condition, such as 'headache,' 'arthritis,' 'heart disease,' or even 'pain' anywhere, not only in testimonials. Symptoms relating to diseases also cannot be used because they IMPLY a disease condition.

Even a factual statement such as, "According to the National Cancer Institute, ingredient X protects smoker's lungs," is considered an impermissible disease claim. Basically, no relationship can exist between a supplement and a disease condition. Even natural states such as pregnancy, menopause and menstrual cycles qualify as diseases! All I can say is, its going to be very hard for alternative health websites to explain their products in anything but the most watered-down of terms. The other major area of concern is that the FDA has taken the position that Internet advertising qualifies as labeling, and therefore falls within its scope of its authority. So, if someone makes a claim that a supplement will treat, cure, prevent, or mitigate a disease, the supplement loses its status as a supplement and is then categorized as a drug.

And, all drugs must pass the FDA's review process to ensure that they are safe and effective for their represented uses. This is a rigorous and incredibly expensive and lengthy review process that nobody really wants to go through - not even the drug companies! But until it is completed, the FDA considers the product to be an unapproved new drug, which may not be marketed. And putting some teeth into their decree, the FDA has the authority to seize the product if it is distributed to the public. Now that's power! Designed to make Internet health marketers shake in their boots, no doubt. The FDA and FTC take the position that they have the jurisdiction to control freedom of speech for the sake of protecting public health. They argue that 'deception' is misleading the public. They are doing their best to discredit promotions that use words like "exclusive products," "secret ingredient" or "ancient remedy" - claiming that these are meaningless scientific terms.

As far as I know, nobody was ever trying to call them scientific terms. They are marketing terms, pure and simple. They were never meant to be scientific. Would you really mistake "secret ingredient" or "ancient remedy" for a scientific term? You'll find these terms in many books on headlines and sales letters. I don't think anyone would be foolish enough to go searching for them in a researcher's study. The government knows these are advertising tools. They allow advertising in every other field. Are they assuming you can't tell the difference? Or are they just trying to confuse you into believing you are being deceived? The government gave their approval for drug companies to advertise their prescription medications in TV commercials and in magazine ads. TV viewers are blasted with them every night. But they want to make sure that information about natural products is suppressed. It doesn't take a rocket scientist to figure out what's going on here.

The FDA claims it is afraid that "people could cancel their surgery, radiation or chemotherapy in favor of herbal cures that cost hundreds of dollars." I'd like to ask if the government has totaled up the cost of surgery, radiation and chemotherapy lately? These established medical treatments total up into the tens of thousands, not hundreds, per person. But I don't see the government concerned about these skyrocketing costs. After all, there's a whole industry out there profiting from it. Think of all the hospitals and cancer centers in existence with all the equipment they purchase and all the people they employ. Think of all the companies that manufacture this specialized equipment. And think of all the medical schools and nursing schools that train doctors and nurses to use it. Think of the drug companies that manufacture chemo and all the money they make from it. And don't forget the insurance companies.

When you think of all this, you can get a picture of the scope of just the 'cancer industry' alone. Yet the government is afraid a few people might spend a few hundred dollars on natural substances? No, they are afraid the cancer industry might lose money. They are afraid that since the sales of health items are increasing, they are losing their edge - that their brainwashing of the public is growing thin. Hence, they have come out with a new campaign of fresh ideas for re-brainwashing the public. Also targeted is a device that delivers a mild electric current that purportedly kills the parasites causing such serious diseases as cancer and Alzheimer's. I tried such a device personally. Did it work? Not in the long run. But I'm glad I had the freedom to try it and find out for myself. The mild electric current didn't hurt me and the cost was insignificant. I also tried colloidal silver and found it didn't work for me. Nor did it harm me.

I really don't need the government's protection for something that is harmless. And I don't need the government making my decisions for me. The FDA and FTC are also concerned that those with HIV or AIDS could use St. John's Wort as a treatment for the disease. And that St. John's Wort is known to interfere with proven HIV/AIDS medications. I seriously doubt that very many HIV or AIDS patients would use St. John's Wort as their sole treatment. But if they do, why should the government prohibit them? Why shouldn't they have the choice? I picked up an issue of 'People' magazine the other day. I was astounded when I opened to a very convincing full-color, two-page ad placed by the government discrediting what they called 'unsubstantiated and undocumented' claims by health companies. They urged readers not to try any health product without discussing it with their doctor first and going to the government website.

Discussing it with your doctor? We can pretty well predict how that will turn out. How many doctors know anything about all the health products available? How many doctors even know anything about nutrition, considering doctors are only required to take one course on nutrition? How many doctors are interested in anything natural, considering they are trained to dispense drugs, and are given bonuses and incentives to do so (even all-expense paid vacations to exotic locations for 'training')? How many doctors even care that the medicine they give you for your heart may damage your nerves or your liver? Several times, I have refused medication due to side effects. I was treated with utter disgust and contempt by the doctors and their staff. A friend of mine canceled surgery on her nose for a skin problem, only to receive an irate call from her doctor who blamed her for negatively impacting his income!

Not only that, but I have seen many of my friends and relatives go through chemo. I've seen what it can do to the body and the brain. And I've seen too many young women die horrible deaths shortly after starting chemo. And still others died the second time around, because the chemo-treated cancer returned. Yet the only three legal treatments for cancer in this country are chemotherapy, surgery, and radiation. Does the government require doctors to give you the rates of failure with chemo or the side-effects of radiation? Does the government even require the doctors to tell you that there were 17,000 deaths from Aspirin alone last year? How about the fact that doctors are the third leading cause of death in America today?

That's right, according to the "Journal of the American Medical Association" Vol. 284 July 26, 2000, things like unnecessary surgery, medication errors, negative effects of drugs, etc., cause almost as many deaths as heart disease and cancer. This comes to a total to 250,000 deaths per year from iatrogenic causes! Iatrogenic means it was caused by a physician's activity, manner, or therapy. And these estimates are for deaths only and do not include negative effects that are associated with disability or discomfort! It is a known fact the US health care system is the most expensive in the world, yet the quality of health in the US rates poorly. In a recent comparison of the health care in 13 countries, the United States ranked an average of 12th (second from the bottom) for 16 available health indicators. In another study by the World Health Organization of 25 industrialized countries, the US ranked 15th.

This prompts me to ask, who is the government protecting? And why?

I'll never forget one brave woman with cancer that I knew who chose to die naturally, without chemo or radiation. She died in peace, surrounded by her loving family, with all her wits about her. In contrast, I remember the horrible deaths of my friends who received full doses of chemo and died anyway. They had loving families too, but they did not die gracefully or in peace. The chemo had affected their mental (and emotional and physical) faculties and they lost touch with the world long before it seemed right. And then, I read about how 'required' food labels, mandated by the FDA, are concealing a hardened killer - trans fat, found primarily in baked foods and snack foods. The labels are not required to mention trans fat. Yet trans fat is considered worse than saturated fat by some scientists. It elevates bad cholesterol; lowers good cholesterol; increases triglycerides; and makes blood platelets stickier, increasing the chance of clots. Even if the saturated fat content of a food is low, the trans fat content can be very high.

Back in 1999 a cost-benefit analysis done for the FDA estimated that labeling trans fat would save $3 billion to $8 billion annually in averted heart disease costs. And labeling would save from 2,000 to 5,000 lives a year. But the FDA has not yet required industrial trans fat to be listed on labels. This means the labels are actually MISLEADING heart patients, diabetics, athletes and millions of other consumers who watch their fat intake. But the FDA has been reluctant to require labeling. Aren't they concerned that 'Nutritional Facts' labels on foods are misleading? Perhaps their logic is, why should they bother the big snack food manufacturers? After all, they insure the hospitals get plenty of patients. And nobody knows about trans fat anyway. It's so much easier to target the health food and supplement industry. It's so much easier to declare that websites are a form of 'labels' and slap on regulations. And its easy to discredit a smaller industry that is concerned about real health.

Every time the FDA attempts to require that nutritional supplements be obtained by prescription only, there is tremendous public outcry. Petitions are circulated, letters are sent in, calls are placed. The government is forced to back off due to public indignation. Now, they have found a way to gain a stronghold. They have found a way to slip suppression of nutritional information past the public. They are hoping you never know of this. And that you don't notice what is not being said so that they can creep a little further, with each new regulation, into taking your health choices away until they are eventually controlling all your health decisions. Ask yourself, whose health is the government really concerned about? Yours or the pockets of the drug and medical industry? Don't let them take your choices away from you.

If we don't speak out individually and collectively, the government will take further infringements upon our freedom of choice in health. If you would like your voice to be heard, please contact your federal representatives and complain. You can find the names and contact information of your representatives here: http://www.house.gov and your senators here: http://www.senate.gov/. And why not send a copy of your letter to the FDA: Gary Dykstra, Deputy Associate Commissioner for Regulatory Affairs, FDA, email: [email protected] (But please don't send this article to the FDA)

Rufina James

P.S. Here's a list of URLs where you can find more information:

The article "Operation Cure.All" targets Internet Fraud" at: http://www.mlmlaw.com/news/opcureall.html

Essential reading - "My testimonial" (discusses use of testimonials) found at:
http://www.mlmlaw.com/saleswatch/saleswatch105a.html#MyTestimonial

Excellent examples given here; legalities explained: (This is a pdf file and requires Abobe Acrobat to view. Well worth it)
http://www.mlmlaw.com/saleswatch/StructureFunctionRule.pdf

More info: http://www.mlmlaw.com/saleswatch.html

Government Sites:

http://www.ftc.gov/opa/2001/06/cureall.htm
http://www.fda.gov/fdac/features/2001/501_war.html

FTC's Virtual Health Treatments website:
www.ftc.gov/healthclaims

FDA's Buying Medicines and Medical Products Online websites:
www.fda.gov/oc/buyonline
www.healthfinder.gov
http://www.fda.gov/opacom/laws/fdcact/fdcact1.htm
http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm

Copyright 2001 Rufina James
www.therealessentials.com

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