FDA Regulations - please write

[Guest guest]

> OPERATION CURE.ALL -- WHO'S CURE?

> by Ruth James

>

> Something very disturbing happened this week. The long arm of

> the government got longer. Going by the name of Operation

> Cure.All, the FDA and the FTC have launched a joint 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 explaning 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 health websites, including

> mine, to explain their products in anything but the most

> watered-down 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. I mean, would you 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. Why is the government implying

> there is deception here?

>> 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 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? No. 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 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 cancelled 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!

>> Doesn't this beg the question, " Is treatment from a doctor

> safe? " Yet I do not see the government addressing this issue in

> any way.

>> 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 in

> 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

> send 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.

>

> -

> Right now there is no coalition to fight the new regulations.

> There is no advocate to represent nutritional companies in

> Washington DC. 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/

>

> FTC Announcement

> http://www.ftc.gov/opa/2001/06/cureall.htm